Background and Aims

To evaluate the safety and efficacy of insulin pump therapy in Iranian people with type 1 diabetes on an insulin regimen with multiple daily injections.

Methods

This study was an observational, non-interventional, prospective, multicentre survey with 6 month-follow-up time in subjects with type 1 diabetes on multiple daily insulin injections (MDI) for whom a continuous subcutaneous insulin infusion (CSII) therapy was recommended. Accu-Chek Combo system insulin pumps were used.

Results

A total of 20 patients were included. The mean age was 12.6 ± 0.61 years. The mean duration of diabetes was 5.7 ± 0.54 years. The mean HbA1c was 9.72±0.5% at baseline, whereas this figure was reported to be 7.58±0.28% by the end of the study. A mean absolute change of -2.14% was observed from baseline. The proportion of patients reaching the target of HbA1c<7% was 30% at month 6. The rate of major and nocturnal hypoglycemia was 41.7 (CI: 5.9 – 77.4) per 1,000 person-months.

Conclusions

Insulin pump therapy effectively reduced HbA1c in Iranian patients with type 1 diabetes with acceptable safety profile.

Background and Aims

Treatment with continuous subcutaneous insulin infusion (CSII) in children with type 1 Diabetes (DM1) may lead to changes in glucose monitoring data and health-related quality of life (HRQOL).

A study was designed to assess differences in glucose monitoring data and HRQOL according to HbA1c as indicator of glycemic control.

Methods

Glycemic metrics were recorded from glucose monitoring devices of 157 children aged 8 to 18, treated with CSII or multiple dose injection (MDI) in 8 Pediatrics Diabetes Units in Spain. These patients filled up DCGM-12 as HRQOL instrument. The patients were divided in three groups: patients with CSII and Hb1c < 7.5%, patients with CSII and HbA1c ≥ 7.5%, and patients with MDI.

Results

Conclusions

The patients treated with CSII whose HbA1c was less than 7.5% had bigger percentage of time in range and less time in hyperglycemia than the group with worse glycemic control.

Both groups of patients with CSII had bigger HRQOL than the patients treated with MDI but the group with CSII and better glycemic control had worse HRQOL than the other CSII group.

Background and Aims

The aim of this study was to identify parameters that contribute the most to the development of large for gestational age (LGA) infants in a cohort of patients with type 1 diabetes mellitus (T1DM) treated with an insulin pump during pregnancy. Furthemore, basal and bolus insulin changes during pregnancy were evaluated.

Methods

The data of patients was retrospectively analyzed. Inclusion criteria were HbA1c ≤7.0% (53mmol/mol), BMI (body mass index) <25kg/m² at the time of conception, duration of T1DM for more than 2 years and treatment with insulin pump for at least 3 months prior to conception. A total of 14 patients were included. Statistical analysis was performed using Wilcoxon signed ranks test and linear regression.

Results

Among several analyzed parameters, only HbA1c in the last trimester was extracted as a significant predictor of birth weight (R square=0.653). Furthermore, preconception maternal body weight correlated positively with HbA1c in the last trimester (p=0.026, r=0.592). Regarding insulin changes, total daily insulin dose (TDI) increased 33% from the conception to the last trimester, 34.7U (13.4-50.6) and 46.2 U (17.5-87.0), respectively. Most of the TDI increase was attributed to the rise of bolus insulin while basal insulin remained fairly constant with basal-bolus insulin ratio changing from 52/48 to 39/61

Conclusions

Preconception body weight and optimal glycemic control during pregnancy, especially in the last trimester, are essential for reducing risk of LGA neonates. Regarding insulin changes, there should be emphasis on increase of bolus insulin as pregnancy progresses.

Background and Aims

To evaluate the effectiveness of treatment CSII therapy for patients with diabetes mellitus of different age groups with long-term follow-up in real clinical practice.

Methods

The total group included 239 children and adolescents with T1D on CSII for 3 years and more, including 126 (53) females and 113 (47%) males. The mean age of children was 12.8±3.5 (range from 4.5 to 18.0 years), 65% of whom were adolescents. To assess the effectiveness of treatment on HbA1c level, the total group was provisionally divided into subgroups by age: 4.5-7 years, 8-11 years, 12-18 years.

Results

The target HbA1c level (<7.5%) was found in 67% of children from 4.5-7 year age group, in 55% from 8-12 year age group, and in 35% from 12-18 year age group (p<0.001).

Conclusions

The specific group that requires attention and stricter metabolic control during the use of the insulin pump consists of adolescents older than 12 years. The essential requirement for success of the therapy is a high level of patient compliance.

In the group of adolescents (12-18 years) only 35% of patients had their HbA1c within the target. Poorer glycemic control in adolescence may be related to changes in endocrine regulation, typical to this age, as well as to psychological and social factors and the desire to become independent and free from parents.

Background and Aims

The real world effectiveness of diabetes technology in pregnant women with type 1 diabetes (T1D) is a matter of debate, but an optimal preconception HbA1c is considered a key factor for a successful pregnancy. Aim of this study is to assess the effectiveness of Insulin Pumps (IP) vs Multiple Daily Injection (MDI) and Continuous Glucose Monitoring (CGM) vs Blood Glucose Monitoring (BGM) in pregnant women with T1D.

Methods

We retrospectively compared fetal, neonatal and maternal complication rate (primary outcome) and preconception - 3rd trimester HbA1c difference (ΔHbA1c) (secondary outcome) between pregnancies managed with IP vs MDI (both with or without CGM) and with CGM vs BGM (both with or without IP).

Results

From 2012 until to 2019 we managed 66 pregnancies in 53 women with T1D (mean age ± SD = 31.1 ± 6.1 years). We didn't find any significant difference in complication rate (pregnancies with complications/without complications) between IP vs MDI (27/26 vs 7/6, n.s.) nor between CGM vs BGM (13/7 vs 21/25, n.s.); ΔHbA1c was significantly higher with IP than MDI (1.43 ± 0.24 vs 0.72 ± 0.91%, p < 0.05) and similar with CGM vs BGM (1.23 ± 1.54 vs 1.29 ± 1.37 %, n.s.). Of note, preconception HbA1c was significantly higher with IP vs MDI (8.21 ± 1.91 vs 6.83 ± 1.11%, p < 0.05).

Conclusions

Despite significantly higher preconception HbA1c, pregnancies managed with IP resulted in a significant reduction of HbA1c and a comparable complication rate in comparison to those managed with MDI but with an optimal preconception HbA1c.

Background and Aims

Background and Aims: Insulin infusion sets are one of the weak links in pump therapy and closed-loop systems. We conducted a randomized blinded study testing a novel infusion set which with and without heparin, hypothesizing that a small amount of heparin infused over multiple days would decrease thrombosis and inflammation around catheters.

Methods

Methods: The catheter hub with cannula was the MiniMed™ Quick-set ™ with a new tubing connector and hub. The connector was modified to contain an inert non-heparin (P) or heparin (80 units) (H) added to the P. Visibly the sets were identical and the study was double blinded. Four infusion sets (two P and two H) were worn by each subject for 7 days or until failure.

Results

Results: 20 subjects were studied (mean age 29.5±8 years). Median (IQR) duration of wear for 40 sets with H was 6.97 (6.5, 7) days and for 40 sets with P was 6.98 (6, 7) days. There were 9 sets in each group that failed before the 6^th day. The mean total daily insulin dose and mean of sensor readings between 2 AM and 6 AM did not differ between the two groups and did not change with day of wear.

Conclusions

Conclusions: There was no difference between the two groups with the modified caps containing either a non-heparin (placebo), or the placebo combined with heparin in overall duration of wear. Both the non-Heparin and Heparin Extended Wear infusion sets had a longer length of wear compared to historical studies using a Quick-Set.

Background and Aims

Insulin infusion pump therapy (IIPT) is the treatment of choice for the treatment of type 1 diabetes mellitus (type 1 DM), especially in patients under five years of age. The aim of this study was to compare the effects of IIPT and multidose insulin therapy (MDT) at the time of diagnosis in children with Type 1 DM on anthropometric measurements, HbA1c, daily insulin requirement and basal-bolus rates.

Methods

10 patients with Type 1 DM who were followed by IIPT at the time of diagnosis and followed up regularly for at least 1 year, and 10 patients with Type 1 DM using MDT, who were similar in terms of age and sex, were included in the study . Daily total insulin (U / kg) requirement, daily basal and bolus insulin rates and HbA1c values ​​of the patients were compared.

Results

The mean age at diagnosis was 2.01 ± 1.28 years in the IIPT group and 3.11 ± 1.49 years in the MDT group . HbA1c values measured in the first year showed a significant decrease in both treatment groups, whereas HbA1c values were significantly lower in the IIPT group compared to the MDT group. In the IIPT group, the mean daily total insulin requirement was lower than MDT group.

Conclusions

It has been shown that in patients with Type 1 DM who use IIPT at the time of diagnosis, 1-year follow-up provides better metabolic control with lower daily insulin dose compared to those using MDT. Long-term studies with more patients are needed.

Background and Aims

Over the past years there was significant innovation in diabetes drug and device development. In Portugal, the universal access to continuous subcutaneous insulin infusion therapy (CSII) is recent; since 2019 all pediatric patients should receive this therapy. The objective of this study was to evaluate glycemic control in patients using CSII and to compare it according to the time of onset.

Methods

We performed a retrospective study, in which we analyzed the patients admitted in a level III Pediatric Hospital with the diagnosis of type 1 diabetes and treated with CSII. There were evaluated demographic and clinical characteristics and laboratory tests (sex, age, date of diagnosis of diabetes, HbA1c and C peptide at the diagnosis, date of CSII onset, HbA1c at CSII onset and six months later). Patients were divided into three different groups: those who started CSII during the first year of disease (1), between the second and the fifth year of disease (2) and after that (3).

Results

We analyzed 124 patients, with a male predominance. The median age at the diagnosis was 8 years old. There were 30 patients in group 1, 64 in group 2 and 30 in group 3. Considering glycemic control, we described a decrease in HbA1c in all groups, which was higher in group 1 (0,83%, 0,65% and 0,23% in group 1, 2 and 3 respectively).

Conclusions

Although not statistically significant, due mostly to the small sample size, we should consider that CSII allows a better glycemic control when started soon after the diagnosis of diabetes.

Background and Aims

Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin administration but requires structured education to provide users with the necessary knowledge/skills and motivation support. CSII offers significant advantages over traditional therapy, but at higher costs, it has been recognized for decades as an integral component of diabetes therapy. Aims: To evaluate the impact in first nine months in Structured Education Program for CSII users in Specialized Center.

Methods

September 2018 to March 2019, we followed 46 Type 1 Diabetes Patients treated in Specialized Center in the Standardized Structured Education Program, specifically developed for CSII users, providing the necessary skills and knowledge for the effective use of this resource and dealing with Psychological barriers to enhance the beneficial effects of the therapy.

Results

66% women, average age 22,9 years. Mean glycemic values in the target ranges: < 54 mg/dL ranged from 3.7 to 6.9%; 55-69 mg/dL ranged from 7.87 to 4.4%; 70-180 mg/dL ranged from 46.2 to 56.1; 181-249 mg/dL that ranged from 17.27 to 18.0; > 250 mg/dL ranged from 24.67 to 11.4. The mean A1C ranged from 8.7% (5,8%-12,8%) to 7.8% (5.5-10.8%).

Conclusions

Reduction of 0,92% in A1C, with improvement in target ranges, increase in range of 70-180 and decrease in others. Clinical benefits and cost-effectiveness are only possible with the care structuring, trained professionals and skilled user to make appropriate decisions, managing problems, assessing and acting based on blood glucose.

Background and Aims

Background: Diabetes is a complex condition, requires multifaceted approaches, where self-management is an essential element. Innovative technology approaches offer a great promise. The Continuous subcutaneous insulin infusion (CSII) has its benefits already well described. CSII is complex for both, patients and professionals, requiring a high level of motivation/engagement. There are very few specialized centers in our country where the CSII is not part of the public health system protocols; therefore, patients receive CSII by lawsuit, with increased costs and without proper follow-up. Aims: To describe the Structured Program for Assistance to users of CSII (DM1), in Specialized Center.

Methods

Increased legal decisions and related costs without: proper training, economic control, and adequate clinical follow-up; The Health Secretariat of our State has created the Structured Care Program with Clinical Inclusion/Follow-up Clinical Protocols, Educational Protocols: Strategies for Assessing/Encouraging Adherence and Self-Management skills development tools at the specialized Center for follow-Up users and families, focusing on: metabolic control and independence.

Results

Started September 2018 with 14 patients, 56% male, average age 23 years, initial average A1C 8.7% (5.8% to 12.1%). June 2019 - 46 patients, 66% women, average age 22,9 years, average A1C 7,84% (5,4 and 9,7%).

Conclusions

Clinical benefits and cost-effectiveness are only possible with the structuring of care, when the CSII is correctly programmed and the user is able to make appropriate decisions and manage problems. Education is structured, curriculum-based that prepares the individual to deal with the worst case scenario.

Background and Aims

Higher bolus frequency is expected to correlate with better glycemic control; however, there is little real-world data quantifying this trend. This study retrospectively assessed glycemic outcomes stratified by bolus frequency for a large cohort of youth with T1D using the Omnipod® Insulin Management System (Insulet Corp., Acton, MA) with an integrated BG meter (Abbott Diabetes Care Inc., Alameda, CA) and data management system (Glooko, Mountain View, CA).

Methods

Insulin pump data uploaded to the data management system from February-August 2019 were matched via device serial number to a second database of self-reported demographic data and de-identified. Data from ≥3 mo of system use per user were analyzed. Glucose Management Indicator (GMI) and percentage of readings <54 and 70-180mg/dL were calculated based on ≥14 days of BG meter readings for users grouped by average bolus frequency (<3, 3-4.99, 5-7.99, or ≥8/day).

Results

In 7,494 youth aged <18y with T1D (aged 12±4y, 50% female), average bolus frequency was 6.1±2.5/day, with 44% of users bolusing 5-7.99 times/day. Increased bolus frequency was correlated with improved GMI (Figure), decreased percentage of readings <54mg/dL, and increased percentage of readings 70-180mg/dL. The percentage of readings 70-180mg/dL increased from 32% with infrequent bolusing (<3/day) to 41% with frequent bolusing (≥8/day), while the percentage of readings <54mg/dL decreased from 2.5% to 1.2%.

Conclusions

Higher bolus frequency was associated with better glycemic control as measured by GMI and percentage of readings in target range in a large cohort of youth with T1D using the Omnipod System in this real-world observational study.

Background and Aims

Diabetes technology use in type 1 diabetes (T1D) management is an increasingly widespread practice. Patient-related outcomes are crucial in the management of diabetes technology. The aim of the study was to analyse the relationship between diabetes technology use and the psychosocial repercussions associated with T1D.

Methods

Patients with T1D who participated in a training program to start CSII, CGM, or SAP were asked to complete some questionnaires: Gold score (GS), Clarke score (CS), Hypoglycaemia Fear Survey (HFS), Diabetes Quality of Life (DQoL), Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Pittsburgh Sleep Quality Index (PSQI).

Results

176 T1D patients were included: age 38±12, 52% men, diabetes duration 18±11 years, HbA1c: 7.4±1.0%. 20% severe hypoglycaemia (last year). Previous treatment: CSII: 18% (n=31), CGM: 10% (n=18), SAP: 13% (n=23).

HFS was higher in patients on MDI compared to patients on CSII (51±25 vs 42±23, p=0.043) DTSQ score was higher in CSII user (30±6 vs 25±6, p<0.0005), CGM (29±7 vs 26±6, p=0.007) or SAP (30±7 vs 26±6, p=0.002) compared to non-users. PSQI was not different in device users vs non-users, being HFS the main predictor of PSQI (p=0.006) in the multivariate analysis. Predictors of DQoL were PSQI (p=0.004), HFS-worry subscale (p=0.012) and DTSQ (p=0.005). HbA1c was not an independent predictor of psychological outcomes.

Conclusions

Patient-related outcomes need to be considered when managing diabetes technology. Diabetes devices help to reduce fear of hypoglycaemia and improve diabetes satisfaction. The relationship between sleep quality and diabetes technology use could be related to improvement of fear of hypoglycaemia and quality of life.

Background and Aims

Background
Use of insulin pumps in T2DM patients require lot of efforts in elderly T2DM patients and that too in India. Financial and social support is must in elderly patients with frailty.Mrs AK is 73 over last two years and happily using it without severe hypoglycaemia. Mrs SD is 67 year old with one year of successful Insulin pump use.

Aims
To empower the use of insulin pumps in T2DM patients especially elderly patients in India.

Methods

Method
AK a 73 yrs teacher used pump for 2 years. She has Ischemic Heart Disease. She was hospitalized with fracture of D10 vertebra due to fall in house because of hypoglycaemia. She had lot of variability in glucose levels with MDI regimen. She has been monitoring her glucose by SMBG even on insulin pump She got AGP done once in Feb 2019. She was dependent on her husband for injection shots during MDI because of her essential tremors.

Another lady Mrs SD is a 67 year old lady with T2DM since 1993. She was having very high insulin requirement on MDI almost 120 units a day. She was admitted with severe hypoglycaemia with unconsciousness in October 2018.She is using Insulin Pump very effectively over last one year. The video recordings of both the patient is available with English subtitles.

Results

She has good glycaemic control and quality of life and independence over 2 years. Mrs SD used Insulin Pump effectively last one year

Conclusions

Insulin Pumps and accessories must be made affordable in India.

Background and Aims

Sensor augmented pump therapy(SAP) decreases glycemic variability(GV) and helps to prevent hypoglycemia. To evaluate the effect of SAP therapy on GV; percentage of time in range, time spent in hypo-hyperglycemia.

Methods

Mean pre-post SAP therapy HbA1c; GV and percentage of Levels 1 and 2 hypo-hyperglycemia and TIR were evaluated in type1diabetic patients followed up between Jan2016 and Nov2018.

Results

Mean age and duration of DM was 12,25±0,62 and 5,75±4,68 years. Twenty of the patients were using standard insulin infusion pump therapy (IPT), 16 were on MDI, and 8 were newly diagnosed at the initiation of SAP therapy. Insulin doses (U/kg), bolus and basal insulin ratios were similar in pre-post SAP therapy after new diagnosis diabetics were excluded. No significant difference was found between the mean HbA1c of the IPT patients in the previous year and first year after SAP therapy on the 3rd,6th and 12th month.

Mean level 2 and 1 hypoglycemia and level 2 and 1 hyperglycemia rates were 0,55±0,52% and 2,13±1,26%; 9,32±10,33% and 20,14±6,27% consecutively. The rate of normoglycemia was 68,63±13,56% after SAP therapy.

In the 1-year follow-up period, mean GV index was measured at 3-month intervals. Although there was no statistically significant decrease in CV values, CV decreased from 36% to 33%. Secondary GV index SD decreased from 59.4 to 56 (p> 0.05)

Conclusions

As a result SAP therapy decreases GV while preventing hypoglycemia as shown by the decrease in SD and CV. With SAP therapy TIR was >65% and the time spent in hypoglycemia was very low.

Background and Aims

Despite using suspend-before-low sensor augmented pump (SBL-SAP), hypoglycemia is still an issue in 20% patients with type 1 Diabetes (T1D). Our aim was to determine factors associated with clinically significant hypoglycemia (<54mg/dl) in persons with T1D treated with SBL-SAP.

Methods

This is a longitudinal, multicenter study performed in Colombia, Chile and Spain. Patients with T1D treated with SBL-SAP using sensor ≥70 % of time, were included. Clinical and laboratory information closest the last upload of SBL-SAP was recorded from electronic records. Data regarding pump and sensor use and carbohydrate intake from 28 consecutive days were collected. A Poisson regression analysis was carried out, evaluating the number of events of <54mg/dl to identify the association with the variables described. A multivariate poisson regression analysis was performed, using the stepwise forward model for the significant variables in the bivariate analysis. The Akaike's and Bayesian information criterion was used to select the best model.

Results

188 subjects were included (41 years-old, 23 years disease duration, HbA1c 7.2%). The number of events <54 mg/dl were 6.70±9.06 events/patient/month, 77% of these events occurred during day time. The risk of hypoglycemia was higher in patients with previous severe hypoglycemia (IRR1.48; 95%CI[1.19-1.61];p=0.002), hypoglycemia unawareness (IRR1.36;95%CI[1.16-1.59];p=0.006), inadequate sensor calibration (IRR1.30;95%CI[1.11-1.51];p=0.017), >60% of total daily insulin dose as bolus (IRR1.31;95%CI[1.12-1.53];p=0.001) and CV% >36% (IRR 2,09;95%CI[1,79-2.45];p<0.001).

Conclusions

In spite of using advanced SAP technology, clinically significant hypoglycemia is still a non-negligible risk. Only the identification and intervention on factors related to that risk could help to prevent and reduce hypoglycemia in clinical practice.

Background and Aims

The governing state-space dynamics, of blood glucose and insulin in human body, are inspired with the Bergman minimal model. The insulin infusion rate, through pump, is added to the model as a dynamic state. This work presents the design and analysis of nonlinear controller to regulate blood glucose level through artificial pancreas.

Methods

The Lyapunov based nonlinear synergetic control technique is employed to design controller for pumping insulin. The complete mathematical derivation and analysis is provided in detail which accounts for the factors such as meal disturbance, physical nonlinearities and sensor noise. The efficiency of the proposed controller and comparison of the results are demonstrated through simulations using MATLAB/Simulink.

Results

With the simulation results we have observed the tracking response of the proposed controller which has been compared with PID controller.

Conclusions

The results show that the proposed controller performs very nicely as compare to the conventional PID controller even in the presence of meal disturbance.

Background and Aims

Background and aims: High prevalence of sleep disturbances have been reported in individuals with type 1 diabetes mellitus (T1DM). The aim of the present study was to assess sleep habits in adults with T1DM and to compare them within insulin regimen [insulin pump (CSII) vs. multiple injections (MDI)].

Methods

Methods: Adults with T1DM were cross-sectionally evaluated. Sleep habits were assessed with Athens Insomnia Scale (AIS) (score 0-24, values ≥6 diagnosing insomnia) validated in the Greek population.

Results

Results: In total 164 adults with T1DM [age: 37 (25, 48) years, Body Mass Index (BMI): 24.8 (21.9, 27.5) kg/m², HbA1c 7.4 (6.8, 8.3) %] were enrolled. 85 patients were on CSII and 79 on MDI treatment. The groups didn’t differ regarding age and BMI. The median AIS score was 4 (2, 7), while the median duration of night sleep was 7 (6, 8) hours. Neither AIS nor sleep duration were significantly correlated with HbA1c. Insomnia was reported by 45% of the CSII group and 27% of the MDI (p=0.02). Furthermore, CSII compared to MDI users reported lower sleep quality (p=0.01) and lower night sleep duration (p=0.02). However, those with CSII and continuous glucose monitoring (CGM) reported longer sleep duration and better sleep quality compared to those with CSII and without CGM (both p<0.05), but similar to MDI users.

Conclusions

Conclusions: In a group of well controlled adults with T1DM, individuals on CSII therapy reported shorter duration and lower quality of sleep compared to those on MDI therapy, a difference which was eliminated among CSII/CGM users.

Background and Aims

Continuous subcutaneous insulin infusion (CSII) therapy using insulin pumps has become widely used in the treatment of type 1 diabetes mellitus (T1DM). This retrospective study aimed to assess the efficacy and safety of long-term insulin pump treatment in patients with T1DM aged ≥50 years.

Methods

The study included patients aged ≥50 years, who had a diagnosis of T1DM based on clinical criteria and/or presence of autoantibodies characteristic of autoimmune diabetes, and had received ≥5 years of recent and uninterrupted treatment with a personal insulin pump. We analyzed records on HbA1c levels across the entire observation period.

Results

The cohort comprised 17 patients, of whom 6 (35%) were men and 11 (65%) were women. The mean duration of observation was 6.6 years, during which patients had a mean of 8.4 HbA1c measurements. Mean HbA1c level over the entire observation period was 6.7% (range, 5.3–7.4%). Overall, 11 patients (65%) had mean HbA1c levels at the ADA-recommended target of <7% and 5 patients (29%) had mean HbA1c <6.5%. Mean HbA1c level was significantly lower at the end of the observation period than at the start (6.52% versus 6.91%; difference, -0.39%; P < 0.01), indicating an improvement in glycaemic control over time. On average, patients experienced one level 1 hypoglycaemia episode every 2.4 days.

Conclusions

This retrospective analysis of at least 5 years of follow-up of selected patients with T1DM aged ≥50 years at the start of observation, showed that CSII is a safe and effective treatment option in this age group.

Background and Aims

Insulin infusion pumps have been used for several years to treat type 1 diabetes in patients with insufficient metabolic control or with complications while on multiple insulin injections treatment. We have analyzed the results of this type of treatment in all patients of our Hospital.

Methods

We have conducted a retrospective, observational and analytical study including all patients undergoing continuous subcutaneous insulin infusion (CSII) in HUCA since its introduction in 2003. All clinical and analytical data and events have been collected until the end of 2018.

Results

102 patients were studied, 25 children and 77 adults. There were 76 women (75%) 26 (25%) men. Median follow-up was 4.2 years. The indications for CSII were gestation, pregestation, poor metabolic control, unawareness hyppoglycemia, unstable control or children.

The device was removed from 12 patients (12%).The previous HbA1c was 7.72% and 3 months after the beginning of the CSII was 7.21% (p <0.01). Reduction of HbA1c occurred in all groups, except in pregnant women.

During the follow-up HbA1c progressively increased without reaching the previous level in all groups except for pregnant women. Final HbA1c was 7,47 %.

While 26% of patients had at least had one episode of severe hypoglycaemia in the year prior to CSII , during more than 4 years of evolution only 14% had severe hypoglycaemia. (p<0.05)

Conclusions

Insulin pump treatment gets

1.-An improvement in short-term metabolic control , 0.5% reduction in HbA1c (p<0.01) that worsened later but without reaching previous level

2.- A Significative decrease of patients suffering severe hypoglycaemia.

Background and Aims

Pregnancy in women with type 1 diabetes (DM 1) is a high-risk group. The aim of our study was to evaluate the results of management of pregnant women with DM 1 using continuous subcutaneous insulin infusion (CSII) in the Republic of Belarus.

Methods

The study included pregnant women with DM 1 (n = 102) who were on pump insulin therapy and were delivered in «Mother and Child» National Research Center in 2009-2019. We estimated gestational age, newborn weight, HbA1c level in the third trimester, number of full-term pregnancies.

Results

Gestational age was 38±1.5 weeks (M ± SD), the weight of newborns was 3442±530 g, the level of HbA1c was 5.9±0.8%. The frequency of full-term pregnancies was 86.3% with the duration of DM 1 - 13.3±6.7 years.

Conclusions

Continuous subcutaneous insulin infusion is an effective method of management of pregnant women with DM 1, which allows to achieve optimal compensation of carbohydrate metabolism, and as a result, full-term pregnancy in 86.3% and the birth of healthy children.

Background and Aims

Individuals with T1D are generally advised to reduce basal rates and increase CHO intake during aerobic exercise. We assessed the effects of a different insulin regimen guided by rtCGM data on CHO intake and glucose levels in 17 T1D adults treated with insulin pumps (11 male, 42±8.8 years, 24±10 years DM duration, 6.6±0.8% A1C) vs. traditional insulin adjustment guidance during 2 consecutive days of extended biking activities with 49 km, 30 miles.

Methods

On day1 (D1) subjects reduced their basal rate by 50% and consumed CHO as guided by their rtCGM (Dexcom G6) data to maintain target range 70-180 mg/dL. Basal insulin infusion was stopped 1hr at the start of the day2 activity (D2) then resumed at a minimal rate 0.23±0,1U/hr during biking. All CHO from 1hour before, during and 10min after the activity was recorded. Times within/below target range, glycemic variability and mean glucose were calculated from rtCGM data.

Results

CHO intake was notably lower during day2 vs. day1 (36±32 vs. 40±27 g, p=NS), with slightly more time in range and <70 mg/dL but no difference in time <54 mg/dL both p=NS. Significant reductions in GV (34±7 vs. 47±13 mg/dL, p<0.01) and slight reductions in mean glucose 124±24 vs. 110±14 mg/dL were seen, p=NS. No severe hypoglycemic events occurred.

Conclusions

T1D individuals using rtCGM in conjunction with insulin pump therapy can safely reduce their CHO requirements during prolonged exercise using the new algorithm.

Background and Aims

Little is known about the psychosocial challenges associated with optimal management of continuous subcutaneous insulin infusion (CSII). This study explored possibilities and barriers to managing diabetes with CSII among individuals with type 1 diabetes.

Methods

We conducted individual semi-structured qualitative interviews with 21 adults with type 1 diabetes treated with CSII, recruited from two Danish diabetes outpatient clinics. The participants were purposefully sampled for heterogeneity. An interview guide with 5 pre-defined themes was used to guide the interviews and the qualitative content analysis.

Results

The 21 participants varied according to sex [women, n=11], age [range 22-71 years], education [short, n=7; medium, n=8; long, n=6], diabetes duration [range 9-66 years], HbA1c [range 37-91 mmol/mol], CSSI duration [range 2-37 years], technical devices [CGM with CSSI, n=14].

Deductive data analysis sorted narrative responses into pre-defined themes (Everyday life with diabetes; CSII history; Everyday life with CSII; Expectations/Outcomes of CSII; Needs and preferences). Inductive analyses indicated that perceptions of CSII therapy were influenced by multiple factors, of which devices and device management were not necessarily to the fore. Individual understandings of what a good life with diabetes was and how to achieve it were the primary drivers of diabetes management. Peer support was identified as a useful resource to improve daily management of CSII.

Conclusions

Possibilities and barriers to CSII therapy are determined by more than functionality of CSII devices. Support with an everyday life perspective from health care professionals and from peers may enhance diabetes management and alleviate challenges.

Background and Aims

As the insulin pump is used often in younger female patients the goal of the study was to investigate the glycemic control during the strength training program.

Methods

Nine female patients (age 25-38) underwent a strength training program consisting of low intensity 5 min aerobic warm up after which they were involved in strength training program in a gym. The total duration of the program was 12 weeks, frequency of 3 times a week, 8 exercises for different muscle groups, intensity 75% of 1RM, 3 sets/12 repetitions.They montored their blood glucose level pre- and post workout on every session and were asked about hypoglycemic episodes.

.

Results

Mean pre-to-post workout glucose concentrations during the first two weeks were compared with the last two weeks. Despite the great variability in pre- and post workout glucose concentrations within and between subjects some changes were observed. There was no significant difference in mean pre- workout glucose concentration betwewen the first two and the last two weeks (8.04±3.11 vs. 7.83±2.95 mmol/L; p=0.52). Interestingly, there was a much larger mean drop in blood glucose after the training after 3 months of the training sessions (pre-to-post workout glucose change: 2.44±0.63 vs. 3.51±1.07mmol/L; p< 0.05). None of the patients reported any hypoglycemia episodes.

Conclusions

As expected, the glycemia before workout was not influenced with strenght program but as it is under the influence of many factors. Nevertheless, the pre-to-post workout drop in glucose increased, probably because the muscle mass increased. The larger muscles were able to spend more glucose and sustaine higher loads.

Background and Aims

There are different therapeutic approaches for type 1 diabetes mellitus (T1DM) based on new technologies such as continuous subcutaneous insulin infusion (CSII) or flash glucose monitoring system (FGMS). Our objective is to assess clinical and QoL impact of three different therapeutic strategies: multiple daily insulin injections (MDI), CSII and MDI+FGMS.

Methods

cross sectional study assessing glucose control and diabetes and hypoglycaemia fear quality of life questionnaires (DQoL and HFS respectively) in 41 T1DM patients on MDI treatment, 42 on CSII and 23 on MDI+FGMS from a university hospital in the North of Spain

Results

mean age was similar in the three groups (42.8-43.8 years, ns). Women were 52-70% in the three groups (ns). Educational status was different amongst groups: 37% university degree in MDI, 64% in CSII and 65% in MDI+FGMS (p<0.05). Patients from CSII group had longer duration of the disease: 24.5 years (7-59) vs MDI 15 (2-36) and MDI+FGMS 18 (1-40) groups (p<0.001). Mean HbA1c showed a non-significant trend towards lower values in MDI+FGMS (7.1±0.7%) vs CSII (7.4±0.8) and MDI (7.6±1.1) groups. MDI+FGMS users had a near to significance trend to better score in DQoL test vs patients from the other two groups (80.5 vs 90 (MDI) and 92.5 (CSII) p=0,09) and showed a non-significant trend in the HFS test towards less hypoglycaemia fear scores.

Conclusions

There is a trend to better glycaemic control, better diabetes related QoL and less hypoglycaemia fear in T1DM patients on MDI+FGMS vs CSII and MDI

Background and Aims

Whether metabolic outcomes improve with continuous subcutaneous insulin infusion (CSII) more than with glucose monitoring systems in patients with type 1 diabetes mellitus (T1DM) remains controversial.

Objective: to assess metabolic changes after CSII or flash glucose monitoring system (FGMS) implementation in T1DM patients from a university hospital in the North of Spain

Methods

prospective and real-life study assessing metabolic outcomes in 110 T1DM patients on multiple daily insulin injections (MDI) before and 1 year after FGMS (41 patients) and CSII (69 patients) implementation.

Results

mean age and gender were similar between groups (42,8 and 44,4 years and 61-63% women). Patients on CSII had longer duration of diabetes: 25 vs 17 years (p<0,005) and more non-proliferative retinopathy (61 vs 12%) rates than patients on MDI+FGMS but there were no differences on proliferative retinopathy and nephropathy. Mean HbA1c was higher at baseline in CSII patients than in MDI+FGMS (7,9±0,9 vs 7,6±1,1%, p<0,05). There were no differences in mild and severe hypoglycaemia episodes, hypoglycaemia unawareness or ketoacidosis between the two groups at baseline. Patients on CSII showed a change in HbA1c (-0,36%, p<0,001) 1 year after but patients on MDI+FGMS did not (-0,16%, ns). There were no differences in mild hypoglycaemia or ketoacidosis in both groups 1 year after. Both groups experienced less severe hypoglycaemia episodes and hypoglycaemia unawareness 1 year after than in baseline (p<0,05).

Conclusions

T1DM patients starting CSII underwent a greater improvement than MDI+FGMS 1 year after. Both groups showed improvement in severe hypoglycaemia and hypoglycaemia awareness.

Background and Aims

The primary container that stores the insulin is one of the key elements of the design of an insulin pump. It shall resist to the environmental conditions linked to a home usage, to the aging and ensure the integrity of the insulin. Debiotech designed a reservoir based on a rigid frame with a flexible membrane. The rigid-flexible design of this reservoir prevents over-deliveries of insulin resulting from variations of temperature and pressure increase.

The challenge by using a flexible membrane is to ensure that insulin stored in the container will keep its integrity.

Methods

The test protocol is based on a comparison between insulin in the reservoir of the pump and insulin inside its original vial. The insulin used for this test session was the insulin lispro.

The insulin was collected from the pump at day 0, at day 2, at day 8, at day 14, at day 21 and day 28. Reference vials were also collected at the same times. And an additional original sealed vial was kept in the fridge at 5°C.

Results

Results showed that insulin characteristics such as physical appearance, potency, purity (presence of polymers), presence of high molecular weight products (HMWP), metacresol concentration and pH were all kept within the pharmacopeia criteria.

Conclusions

The introduction of a flexible membrane in the design of the primary container prevents over-deliveries of insulin resulting from variations of temperature and pressure increase. The proposed design is able to store the insulin for at least 14 days by keeping its main properties.

Background and Aims

Continuous Subcutaneous Insulin Infusion (CSII) enables food freedom in type 1 diabetes (T1DM). Evidence supporting advanced insulin bolus options with CSII is lacking or conflicting, and clinical guidelines are absent. The aim of this national survey was to establish current practice among T1DM specialist dietitians.

Methods

A 19 question survey was sent to the British Dietetic Association’s Diabetes Specialist Group, which consists of approximately 600 Dietitians with a special interest in Diabetes.

Results

78 people completed the questionnaire. 97% always or mostly recommended using bolus advisor on their pumps. 78% said their patients mostly used it. 61% recommended bolusing insulin before their meal. 97% recommended their patients use extended boluses in some form. The most recommended option was the 50:50 combination bolus. Extended boluses were recommended by 91% of respondents for high fat meals, and for foods high in protein and fat (78%), when eating high-fat home-cooked meals (77%) and foods containing significant soluble fibre (60%). 36% of respondents recommend that patients bolus additional insulin for protein or fat and protein. 45% recommended superbolusing.

Conclusions

Bolus advisors are generally used widely, allowing consistent calculation and tracking of insulin. The range of bolus types recommended by dietitians varied reflecting the conflicting evidence, but initial bolus and duration may be insufficient to inhibit hepatic glucose production and cover delayed macronutrient absorption. Extended bolusing was recommended, mostly appropriately. Relatively small numbers advise protein and fat counting. Superbolusing is under-utilised, reflecting the lack of published data, and inconvenience.

Background and Aims

Continuous Subcutaneous Insulin Infusion (CSII) enables greater food freedom for people with type 1 diabetes (T1DM). Evidence supporting advanced insulin bolus options with CSII is poor, with no clinical guidelines. This national survey establishes current practice among type 1 diabetes (T1DM) specialist dietitians.

Methods

A 10 question survey was sent out electronically to the British Dietetic Association’s Diabetes Specialist Group in 2015 and in 2019.

Results

101 dietitians responded in 2015, 78 in 2019. The most popular extended bolus format in both 2019 and 2015 was the 50:50 dual wave, which 85% recommended (89% in 2015). Square wave boluses were the second most popular bolus in 2015 with 80% recommending it’s use, falling to 59% in 2019. In 2015 the 30:70 dual wave was third most popular with 75% recommending, falling to 49% in 2019. Extending over 2-3 hours was most commonly recommended in 2019 (43%), with 1-2 hours most common in 2015 (39%). The maximum duration recommended was 5-6 hours (36%) in 2019 (23% in 2015). 36% of 2019 respondents recommend that patients bolus additional insulin for protein or fat and protein (compared with 9% in 2015). 45% of respondents recommended superbolusing, an increase from 2015 (25%).

Conclusions

Bolus advice from specialist dietitians has improved over 4 years with longer combination boluses, superboluses and protein and fat counting advocated. This reflects improved education and suggest improved tools to support total macronutrient and superbolusing may be required.

Background and Aims

Data show greater mortality and cardiovascular events (CV) in women with T1DM compared to men. A continuous quality improvement initiative is in place in Italy (AMD Annals) since 2005. We evaluated gender differences in metabolic control and overall quality of care among T1DM patients on MDI or CSII.

Methods

Anonymous data from patients with T1DM seen in 2016 were extracted from electronic medical records of 222 diabetes clinics. The achievement of therapeutic targets and the Q Score, a validated overall quality of care indicator correlating with CV risk, were assessed.

Results

Overall, 13,048 women and 15,488 men with T1DM were evaluated. Mean age was 47.3±17 years for women and 46.4±16.1 years for men. Overall, 15.5% of women and 10.1% of men were on CSII. Among patients on CSII, mean HbA1c levels were 7.6±1.1% in women and 7.5±1.1% in men (p<0.0001). Among patients on MDI, HbA1c levels were 8.0±1.4% in women and 7.8±1.3% in men (p<0.0001). Among patients on CSII, HbA1c level <=7% was found in 35.5% of men vs. 30.9% of women (p=0.004); among those in MDI, 30.3% of men and 24.2% of women reached the target (p<0.0001). The mean Q score was higher in people on CSII (women: 28.5±8.3; men: 28.0±8.1; p=0.04) compared to those on MDI (women:26.7±8.4; men: 26.7±8.6; p=0.66).

Conclusions

T1DM women have a worse metabolic control, irrespective of treatment modality. In both genders, CSII is associated with better metabolic control and better overall quality of diabetes care. Despite worse metabolic control, women on CSII have a better Q score.

Background and Aims

Education is considered essential for success with insulin-pump therapy but literature in the field is limited. We systematically reviewed the literature to study re-training programs and their effects in adults (16+) with type 1 diabetes using an insulin pumps with or without continuous glucose monitoring.

Methods

Systematic searches were carried out in MEDLINE, Embase, CINAHL and ERIC. All primary studies reporting an effect of insulin pump retraining education programs were included if they were published in English between January 1999 and May 2019. Results reported here are preliminary and descriptive.

Results

988 studies were identified as potentially relevant; 48 were assessed in full text. Nine studies fulfilled the inclusion criteria including one randomised controlled study. Educational approaches and settings were sparsely described. Content was usually reported as teaching points. One study tested web-based versus face-to face teaching, the remaining compared usual care with an added educational intervention. Studies reported a broad variety of outcomes, e.g. HQoL, diabetes distress, hypoglycaemic events and diabetic ketoacidosis. Four studies reported on knowledge and application skills, all demonstrated improvements. Four studies measured metabolic outcomes by HbA1c before and after re-training, a significant reduction was seen in three. Two studies measured severe hypoglycaemic events before and after re-education intervention, a significant reduction was seen.

Conclusions

Preliminary evaluation indicate that re-education have beneficial effects, but evidence is heterogeneous across study designs and outcomes. Critical appraisal and systematic analyses are in progress to provide substantial recommendations for future education, practice and research.

Background and Aims

Background: Diabetes is a complex condition, requires multifaceted approaches, where self-management is an essential element. Innovative technology approaches offer a great promise. The Continuous subcutaneous insulin infusion (CSII) has its benefits already well described. CSII is complex for both, patients and professionals, requiring a high level of motivation/engagement. There are very few specialized centers in our country where the CSII is not part of the public health system protocols; therefore, patients receive CSII by lawsuit, with increased costs and without proper follow-up. Objective: To describe the Structured Program for Assistance to users of CSII (DM1), in Specialized Center

Methods

Method: increased legal decisions and related costs without: proper training, economic control, and adequate clinical follow-up; The Health Secretariat of our State has created the Structured Care Program with Clinical Inclusion/Follow-up Clinical Protocols, Educational Protocols: Strategies for Assessing/Encouraging Adherence and Self-Management skills development tools at the specialized Center for follow-Up users and families, focusing on: metabolic control and independence

Results

Results: Started September 2018 with 14 patients, 56% male, average age 23 years, initial average A1C 8.7% (5.8% to 12.1%). June 2019 - 46 patients, 66% women, average age 22,9 years, average A1C 7,84% (5,4 and 9,7%).

Conclusions

Conclusion: Clinical benefits and cost-effectiveness are only possible with the structuring of care, when the CSII is correctly programmed and the user is able to make appropriate decisions and manage problems. Education is structured, curriculum-based that prepares the individual to deal with the worst case scenario.

Background and Aims

Background: Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin administration but requires structured education to provide users with the necessary knowledge/skills and motivation support. CSII offers significant advantages over traditional therapy, but at higher costs, it has been recognized for decades as an integral component of diabetes therapy. Objective: To evaluate the impact in first nine months in Structured Education Program for CSII users in Specialized Center

Methods

Method: September 2018 to March 2019, we followed 46 Type 1 Diabetes Patients treated in Specialized Center in the Standardized Structured Education Program, specifically developed for CSII users, providing the necessary skills and knowledge for the effective use of this resource and dealing with Psychological barriers to enhance the beneficial effects of the therapy.

Results

Result: 66% women, average age 22,9 years. Averages of the glycemic values in target ranges (time in range-TIR): < 54 mg/dL ranged from 3.7 to 6.9%; 55-69 mg/dL ranged from 7.87 to 4.4%; 70-180 mg/dL ranged from 46.2 to 56.1; 181-249 mg/dL that ranged from 17.27 to 18.0; > 250 mg/dL ranged from 24.67 to 11.4. The mean A1C ranged from 8.7% (5,8%-12,8%) to 7.8% (5.5-10.8%).

Conclusions

Conclusion: Reduction of 0,92% in A1C, with improvement of the TIR, increase in range of 70-180 and decrease in others. Clinical benefits and cost-effectiveness are only possible with the care structuring, trained professionals and skilled user to make appropriate decisions, managing problems, assessing and acting based on blood glucose.

Background and Aims

Good glycaemic control is often difficult to achieve in patients with type 1 diabetes mellitus (T1DM), especially without increasing time spent in hypoglycaemia. Recently, MiniMed 670G hybrid closed loop insulin pump system has been introduced into clinical practice. The aim of this analysis was to evaluate the effect of MiniMed 670G Auto Mode (AM) on the glycaemic control in the first 12 weeks after AM initiation in routine clinical practice.

Methods

Twelve T1DM patients (aged 42.0±15.6 years, duration of diabetes 27.5±15.9 years) using Medtronic MiniMed 670G hybrid insulin pump and continuous glucose monitoring (CGM) system were included in the analysis. HbA1c level was measured at baseline and after 12 weeks. The CGM data of the preceding two weeks were analysed at the time of the AM initiation and after 12 weeks of treatment. Several parameters were determined and analysed: time in range (TIR; % of readings 3.9-10.0 mmol/l), time above range (TAR; % of readings >10.0 mmol/l), time below range (TBR; % of readings <3.9 mmol/l) and time in AM.

Results

Twelve weeks after AM initiation HbA1c level significantly decreased from 7.8±0.8% to 7.1±0.6 (p=0.002). TIR increased from 69.4±7.5 to 71.8±7.6 % (NS). TAR increased only slightly from 26.5±8.0 to 26.7±7.8 % (NS). TBR significantly decreased from 4.1±4.5 to 1.5±1.0 (p=0.04). Average percentage of time in AM after twelve weeks was 89.2±9.1 %.

Conclusions

The introduction of MiniMed 670G hybrid closed loop insulin pump AM system quickly improves overall glycaemic control and decreases time spent in hypoglycaemia, without increasing time spent in hyperglycaemia.

Background and Aims

To determine the efficacy and safety of continuous subcutaneous insulin infusion (CSII) in attaining long-term glycaemic control and improved quality of life in Type 1 Diabetes Mellitus (DM) patients, who were previously treated with multiple daily injections (MDI).

Methods

From April 2006 to May 2018, 140 Type 1 DM patients were followed, (mean age 33,7±22,1 years; 54 males, 76 females, 10 children; duration of diabetes 19,1±8,4 years; total daily insulin dose on MDI (IU/day) 57,86±15,32; HbA1c (%) at the beginning of CSII treatment 8,67±1,54). HbA1c, glucose levels, BMI, severe hypoglycemic and diabetic ketoacidosis (DKA) episodes were recorded on a regular basis and compared to the data prior to CSII introduction. The evaluation of quality of life was assessed by a self-questionnaire adjusted from the SF-12 and diabetes quality of life (DQoL) questionnaires.

Results

Significant improvement was observed in all glycaemic parameters. HbA1c decreased from 8,67% ±1,54 at baseline to 6,85% ±0,52 (p0,001)(fig.1). Daily insulin requirements decreased to (36,40±12,20 IU/day) compared to baseline needs (57,86±15,32IU/day) (p0,001). BMI showed no significant alterations. The overall rate of hypoglycaemia was decreased by 71,5% (p0,001). Only 3 ketoacidosis incidents were recorded. Quality of life parameters were remarkably improved.

fig.1 Change in HbA1c levels

Conclusions

CSII treatment is superior to MDI schemes for Type 1 DM patients. CSII offers a safe, effective alternative to MDI schemes, with less side-effects, improved glycaemic control and quality of life.

Background and Aims

Predictive Low Glucose Management (PLGM) may help prevent hypoglycemia by stopping insulin pump delivery based on predicted sensor glucose (SG) values. However, its capacity to resolve hypoglycemia unawareness and to improve quality of life remains theoretical.

Methods

PLGM was tested for one year in real life conditions with a system composed of a Paradigm 640G insulin pump with SmartGuard technology in a group of 20 patients age 42.5 (20-59) years, with type 1 diabetes duration 26 (7-47) years, mean ± SD BMI (kg/m2) 25.5 ± 3.6 and HbA1C 8.18±0.8%. Patients were contacted monthly by phone with consultations every 3 months.

Results

PLGM reduced hypoglycemia (<70 mg/dL) compared to no insulin suspension with time below range of 1.11±0.32% at one year. Mean (±SEM) sensor glucose value (187.2±3.74 vs 188.1±4.96 mg/dl) and mean±SEM suspension time (128±11.9 min vs 109±19) did not change between 1 and 12 months. Mean HbA1C levels decreased from 8.11±0.17 to 7.81±0.17% (p<0.0001, one way ANOVA). Clarke score decreased from 2.89±0.55 [1.72-4.06, 95%CI] to 1.26±0.39 [0.43-2.09, 95%CI] at one year, (p=0.013). Rand Health quality of life questionnaires (SF-36) show improvements in the general health score (p<0.02) and no change in the 8 other medical outcomes. Both TRIM-D and TRIM-D device questionnaires showed no aggravation of disease burden by devices.

Conclusions

PLGM provides significant improvement beyond HbA1C with marked reduction of time below range, reduction of hypoglycemia unawareness and improvement of general health without increase in disease burden due to external equipment.

Background and Aims

Recently, a new patch pump for insulin pump therapy was released. In this study, data obtained on the basal rate accuracy of the new pump were assessed and compared to data obtained with a previously tested established patch pump.

Methods

In an experimental setting following procedures of EN 60601-2-24, basal rate accuracy of the Accu-Chek^® Solo micropump was evaluated. Basal rates of 0.1 U/h and 1 U/h were tested in 9 repetitions and accuracy was determined based on weight increases over 72 h. In addition, delivery during each hour was assessed, applying limits of ±15% from target.

Results

Over the whole 72 hours of the experiment, the deviation from the expected target weight was -5.3% at a basal rate of 0.1 U/h. The pump showed a slightly lower mean weight increase (-1.9%) than expected with a preset basal rate of 1 U/h. Larger deviations were observed during the first 24 h. Of individual 1-hour windows, 51% (0.1 U/h) and 98% (1 U/h) were within ±15% of target.

Conclusions

The new patch pump delivered insulin more accurately with the larger basal rate than at the small basal rate. Compared to the previously tested Omnipod, mean deviation at the larger basal rate was similar, but precision was higher for the Accu-Chek Solo micropump, especially at the low basal rate.

Background and Aims

Insulin pumps require an alarm feature to notify the user about occlusions in the tubing or the catheter tip to ensure adequate insulin supply. There is no explicit demand regarding a maximal delay time between occlusion and alarm. In this study, occlusion detection time of two new patch pumps was evaluated and compared to previous data from an already established patch pump.

Methods

Soft cannulas of the Accu-Chek^® Solo micropump [ACS] and the A6 TouchCare^® pump [A6] were occluded with a clamp and time until an occlusion alarm occurred was stopped using two different basal rates (1 U/h and 0.1 U/h). Each experiment was repeated 9 times.

Results

At the 1 U/h basal rate, the mean occlusion detection time was 02:57 (hh:mm) for ACS and 07:26 for A6. Using the smaller basal rate of 0.1 U/h, an alarm occurred after 35:11 for ACS. For A6 no occlusion alarm occurred in any of the 9 repetitions until the end of the pump run time.

Conclusions

Occlusion detection was faster in ACS than in A6; however, for the low basal rate it was markedly delayed in both pumps. This was also observed for the previously tested Omnipod. At the larger basal rate, ACS provided the alarm earlier than the Omnipod.

Background and Aims

Insulin pump features such as temporary basal rate and extended bolus (TBR/EB) provide people with diabetes the ability to customize their insulin therapy to meet their needs. This study retrospectively assessed glycemic outcomes stratified by frequency of TBR/EB use for a large cohort of people with T1D using the Omnipod® Insulin Management System (Insulet Corp., Acton, MA) with an integrated BG meter (Abbott Diabetes Care Inc., Alameda, CA) and data management system (Glooko, Mountain View, CA).

Methods

Insulin pump data uploaded to the data management system from February-August 2019 were matched via device serial number to a second database of self-reported demographic data and de-identified. Data from ≥3mo of system use per user were analyzed. Within each age group (<6y, 6-12.99y, 13-17.99y, 18-25.99y, 26-49.99y, and ≥50y), Glucose Management Indicator (GMI) was calculated based on ≥14 days of BG meter readings for those users who regularly (≥3.33% of days with gaps <60 days, ≥3mo of use) and infrequently (<3.33% of days) used TBR/EB.

Results

Of 11,977 users with T1D, there were 6,448 regular users and 4,908 infrequent users of TBR/EB. In each age group, GMI was significantly lower for regular users of TBR/EB than infrequent users (p<0.001). The number of users per age group and the GMI with regular or infrequent TBR/EB use are shown in the Figure.

Conclusions

While we cannot determine causation, regular users of TBR/EB have better glycemic outcomes than infrequent users. These real-world data support the training of people with T1D and caregivers on the effective use of these features.

Background and Aims

Accuracy of insulin pumps is of current interest, especially with regard to development of closed loop systems. This study evaluated accuracy of the three most recent durable insulin pumps with regard to bolus and basal rate delivery.

Methods

The three durable pumps MiniMed^® 670G [670G], t:slim X2 [TS] and mylife™ YpsoPump^® [YP] were tested. Experimental testing was based on EN 60601-2-24 which requires a microgravimetric procedure. Basal rates of 0.1 U/h and 1 U/h, and boluses of 0.1 U, 1 U and 10 U were tested in 9 repetitions each. Basal rate delivery was assessed for 72 h evaluating each hour separately. Limits of ±15% from target were applied.

Results

The results are shown in the table.

Conclusions

Accuracy of the new pumps fits well into the picture of previously tested durable insulin pumps. In general, accuracy is higher with larger boluses or basal rates.

Background and Aims

Patch pumps are a tubeless alternative to conventional durable insulin pumps. Data obtained with two recently released new patch pumps were compared with data previously obtained with an established patch pump.

Methods

Delivery accuracy of the two insulin patch pumps Accu-Chek^® Solo micropump [ACS] and A6 TouchCare^® pump [A6] was tested in an microgravimetric experiment based on IEC 60601-2-24 for bolus sizes of 0.2 U, 1 U and 10 U. For the already tested Omnipod^®, data were only updated testing 0.2 U boluses. Each insulin pump was tested 9 times. One data set comprised 25 (0.2 U and 1 U) or 12 boluses (10 U). A deviation of more than ±15% from target was considered relevant. In addition, delivery speed of a 10 U bolus was assessed.

Results

Bolus accuracy results are shown in the table. Mean delivery time of a 10 U bolus ranged from 04:00 min [ACS] to 06:40 min [A6].

^*results from previous tests

Conclusions

All patch pumps had a mean deviation of less than 5% for all bolus sizes. ACS, however, had a higher percentage of individual boluses within ±15% of target than the two other pumps for the two smaller bolus volumes.