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ORAL PRESENTATION SESSION
Date
Thu, 03.06.2021
Session Type
ORAL PRESENTATION SESSION
Session Time
20:30 - 21:50
Room
Hall D
ORAL PRESENTATION SESSION

ACUTE CLINICAL OUTCOMES IN COVID-19 POSITIVE PATIENTS WITH TYPE 1 DIABETES (T1D) USING INSULIN PUMP FOR DIABETES MANAGEMENT: DATA FROM THE T1D EXCHANGE COVID REGISTRY

Abstract

Background and Aims

The use of continuous subcutaneous insulin infusion (CSII) has demonstrated fewer acute complications in patients with type 1 diabetes (T1D). This study aims to examine the frequency of adverse clinical outcomes among T1D patients who tested positive for COVID-19 and were users versus non-users of insulin pump therapy.

Methods

The analysis included 241 T1D patients from the T1DX-QI COVID-19 registry who tested positive for COVID-19. Healthcare providers extracted patient data from electronic medical records of 52 endocrinology clinics across the U.S. Data was collected from April 2020 to September 2020.

Results

In this population, 38% (N=92) of T1D patients were insulin pump users, whereas 62% (N=149) were non-users. HbA1c levels in the insulin pump group were lower compared to non-users (Median [IQR], %: 8.0 [1.9] vs. 9.8 [3.7] [p<0.001]). Adverse events, such as diabetic ketoacidosis, were less frequently recorded for insulin pump users relative to the non-users (9% vs.30%) [p<0.001]. Further, patients who did not use insulin pump therapy were more likely to be hospitalized (29% vs.12%) [p<0.001] or need ICU care [25% vs.4%) [p<0.001] than patients who used insulin pumps.

inspump_table.png

Conclusions

Patients with established T1D and COVID-19 who used insulin pump therapy for diabetes management had lower rates of adverse clinical outcomes.

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ORAL PRESENTATION SESSION

PATIENT REPORTED PREFERENCES FROM THE PRO SOLO: NOVEL PATCH PUMP CLINICAL TRIAL

Abstract

Background and Aims

Patch pumps have become a relevant alternative to classic tethered (tubed) insulin pumps. Patient Reported Outcomes (PROs) play a vital role in understanding the ability/willingness of individuals to engage with such systems. We aimed to investigate the preferences of participants using the novel AccuChek Solo (ACS) pump.

Methods

Participants with T1D naïve to insulin pump therapy (39.0 ±11.9 years, 44% female, 15.0±10.8 duration of diabetes, HbA1c 8.0 ± 0.6% (70.5 mmol/mol) enrolled in a multinational RCT were asked to provide feedback on the ACS pump. Participants were either ACS direct users or switched from MDI six months into the study.

Results

Benefits of ACS were reported by n=180 participants (n=133 ACS direct use, n=47 MDI switchers), providing n=226 individual coded responses. Most cited benefits: wireless (n=37), quick bolus (n=32), no injections (n=28), bolus calculator, ease of use and discretion (all n=22). Most useful attributes reported by n=166 participants (n=166 individual responses): bolus calculator (n=64), flexible basal/bolus rates (n=42) and quick bolus function (n=41). Downsides were reported by n=166 participants (n=216 individual responses): manager not a smartphone app (n=57), not waterproof (n=39) and needs greater compatibility with other systems eg flash/CGM/BG meter (n=26)

Conclusions

Users overwhelmingly found the bolus calculator/device manager most useful and benefitted from the wireless, discreet nature of the system. Integration of the manager into a smartphone was recommended by most and a waterproof version desirable by many. Results indicate ACS is an acceptable therapy choice with potential to improve biomedical and psychosocial outcomes of users.

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ORAL PRESENTATION SESSION

GLYCEMIC PROFILES AND TREATMENT PATTERNS: REAL-WORLD DATA FROM 13,109 PEOPLE IN EUROPE AND CANADA WITH DIABETES USING A TUBELESS INSULIN PUMP WITH CLOUD-BASED DATA MANAGEMENT

Abstract

Background and Aims

Real-world data has been recognized as an important tool to better understand the impact of diabetes technology on clinical outcomes of people with diabetes. This retrospective study analyzed data from a large cohort of patients with diabetes using a tubeless insulin pump (Omnipod® Insulin Management System) with CGM or an integrated blood glucose (BG) meter and a data management system to characterize glycemic profiles, insulin use and treatment patterns.

Methods

Tubeless insulin pump data was generated between December 1, 2018 and November 30, 2019 and uploaded to the data management system from Europe and Canada. CGM, BG and insulin data from users with ≥3 months system use were analyzed.

Results

Data from 13,109 users from the United Kingdom (25.3%), Sweden (18.3%), the Netherlands (12.6%), Canada (29.2%) and other (14.6%) were included. Glycemic profiles (mean±SD) for the CGM cohort included mean glucose of 177±32mg/dL, and percentage time <70mg/dL of 5.6±4.3%, in target range (70 to 180mg/dL) of 52.6±14.6% and >180mg/dL of 41.8±15.9% (see Table for BG results). For the total population, mean total daily insulin was 40.6±17.6U/d which was delivered as 47% basal and 53% bolus. There was an average of 5.9±2.2 bolus deliveries per day and the average bolus amount was 4.2±2.5U.

Conclusions

This is the first study of real-world data on glycemic profiles and treatment patterns from a large cohort of people using a tubeless pump in Europe and Canada. It demonstrates glycemic levels comparable to published worldwide data using other means of intensive insulin regimens.

diasend table image-01.png

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ORAL PRESENTATION SESSION

GLYCEMIC IMPROVEMENT IN 1,311 PATIENTS WITH TYPE 1 DIABETES (T1D) USING THE OMNIPOD DASH® INSULIN MANAGEMENT SYSTEM OVER FIRST 90 DAYS OF USE

Abstract

Background and Aims

Clinical outcomes describing real-world use of various devices by people with T1D are important to support decision-making. This retrospective study characterized patient-reported clinical outcomes of people with T1D in the United States before (baseline) and 90 days after (follow-up) initiation of the tubeless Omnipod DASH® Insulin Management System.

Methods

The primary outcome was change in self-reported HbA1c levels from baseline to follow-up. Secondary outcomes were change in self-reported total daily dose (TDD) of insulin and self-reported frequency of hypoglycemic events (HE) per week (#/week <70 mg/dL). Outcomes were assessed overall, by prior treatment modality (MDI or CSII), and by age (<18y, ≥18y).

Results

Patients (n=1,311) were divided into 2 age groups (<18y: n=405, ≥18y: n=906) aged 9.9±4.2y and 45.9±16.9y (mean±SD) and 49.6% and 60.7% female, respectively (Table 1). The overall change in self-reported HbA1c at follow-up was -0.9±2.0% for patients <18y (p<0.0001) and -0.8±1.4% for patients ≥18y (p<0.0001). The change in HbA1c for prior MDI and prior CSII users was ‑1.0±2.1% (p<0.0001) and -0.4±1.3% (p>0.05) in patients <18y, and -0.9±1.6% (p<0.0001) and -0.5±1.0% in patients ≥18y (p<0.0001), respectively. Overall change in TDD of insulin for patients <18y and ≥18y was ‑1.7±10.9U/d (p>0.05) and -12.8±27.7U/d (p<0.0001) and the self-reported HE frequency decreased significantly by -1.4±2.9 (p<0.0001) and -1.9±3.2 (p<0.0001) episodes per week, respectively.

Conclusions

This large cohort of patients with T1D using the Omnipod DASH® Insulin Management System exhibited significant reductions in HbA1c, TDD of insulin, and number of HE after 90 days of use across both age groups.

pro dash t1d 150ppi.png

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ORAL PRESENTATION SESSION

FEASIBILITY CLINICAL STUDY ASSESSING THE COMPATIBILITY OF INSULIN FIASP WITH MEDTRONIC 7-DAY EXTENDED WEAR INFUSION SET

Abstract

Background and Aims

Fiasp® (Faster Insulin Aspart) is approved to be administered through a pump with an infusion set for up to 3 days, with recommendations to monitor pump settings and hypoglycemia closely. Medtronic Extended Wear Infusion Set (EWIS) is CE marked to infuse insulin Lispro and Aspart subcutaneously via Medtronic insulin pumps for up to 7 day. This feasibility study is aimed to evaluate safety and efficacy of EWIS delivery of Fiasp® for up to 7 days.

Methods

This is a single-center, prospective, open label one arm study of up to 40 subjects who use EWIS with a target for 20 subjects to complete the study. Subjects subjects used EWIS with Fiasp® Insulin with MiniMed™ 640G/670G Insulin Pumps for 4 weeks that will serve as an exploratory pilot study to assess the 7-day survival of EWIS with Fiasp® Insulin. All subjects will be instructed to change sets every 7 days or at set failure.

Results

The data collected up to date indicates that Fiasp® can be administered by EWIS for up to 7 days safely. Survival rate collected so far is with the EWIS survival rate of delivering Lispro/Aspart.

Conclusions

This is the first trial of a 7-day infusion set for Fiasp® use in insulin infusion pumps. Clinical data obtained from this prospective, single site study demonstrates that using MiniMed™ 640G/670G pumps with EWIS for subcutaneous delivery of Fiasp® for up to 7 days it both safe and efficacious.

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ORAL PRESENTATION SESSION

SKIN DEPTH AND SUBCUTANEOUS REACTIONS TO DIABETES DEVICES IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES MEASURED BY ULTRASOUND

Abstract

Background and Aims

More than 80% of pediatric patients with type 1 diabetes in Denmark are using diabetes devices, unfortunately, up to 30% suffer from dermatitis. To extend areas for insertion ultrasound can visualize skin depths. Therefore, primary aim of present study is to describe the skin depths in a cohort of pediatric patients.

Methods

In a prospective study on pediatric patients, ultrasound was performed. The distance from skin surface to muscular fascia was measured. All manufacturers were contacted to elaborate the actual skin depth of their device. Additionally, the echogenicity of dermis and subcutis was investigated as a mark of tissue changes.

Results

A total of 103 pediatric patients (age 2–18 years) were included in our analyses. In the upper arm, the mean distance from skin surface to muscular fascia was 5.63 mm (SD 2.34) in the youngest age group (2–6 years) increasing to 10.01 mm (SD 5.20) in 15–20-year old, similar results with increasing distance with age was found for other skin sites. According to the manufacturers the skin depths of devices were ranging from 5–12 mm. Increased echogenicity (tissue condensation) of subcutis were seen in 19 patients (18%).

Conclusions

Skin depths at different sites increases by age and were in some patients less than the depth of device. Increased echogenicity in subcutis was seen in 18% of the patients. How the skin depth and the increases echogenicity influence functionality of the sensor remain unknown.

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ORAL PRESENTATION SESSION

CENTER DIFFERENCES IN DIABETES TREATMENT OUTCOMES AND INSULIN PUMP USE AMONG CHILDREN WITH TYPE 1 DIABETES: A NATIONWIDE STUDY OF 3,866 DANISH CHILDREN

Abstract

Background and Aims

Differences in mean HbA1c across treatment centers are well established, but less well understood. The aim was to assess the importance of disparities in the patient case-mix in explaining the variation in mean HbA1c between pediatric treatment centers in Denmark. The association between glycemic control, frequency of blood glucose monitoring (BGM), treatment modality, and number of clinic visits per year was also investigated.

Methods

This was a longitudinal nationwide study of 3,866 Danish children with type 1 diabetes between the years 2013-2017 (n= 12,708 child-year observations). The children were followed in 16 distinct pediatric diabetes clinics. Mean HbA1c, proportion of children reaching treatment target (HbA1c≤58mmol/mol (7.5%)) were compared across clinics using linear regression models. This was done with and without adjustment for socioeconomic characteristics (patient case-mix).

Results

slide1.jpgThe mean difference in HbA1c during follow-up was 11.6mmol/mol [95% CI 7.9, 15.3] (1.1% [95% CI 0.7, 1.4]) between the center with the lowest vs. highest mean HbA1c. The difference was attenuated and remained significant after adjustment for the patient case-mix (difference: 10.5mmol/mol [95% CI 6.8, 14.2] (1.0% [95% CI 0.6, 1.3])). Overall, only 6.8% of the differences in mean HbA1c across centers were explained by differences in the patient case-mix. Higher BGM was associated with lower HbA1c (Figure 1). Proportion of insulin pump users and number of visits was not associated with HbA1c.

Conclusions

Large, significant differences in HbA1c across centers were found, and this was not explained by patient background. Visits and insulin pump use was not associated with HbA1c.

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ORAL PRESENTATION SESSION

MEDTRONIC 640G VS TANDEM BASAL IQ DURING THE FIRST 3 MONTHS OF DIABETES SINCE ONSET IN VERY YOUNG CHILDREN.

Abstract

Background and Aims

Type 1 diabetes (T1D) management in young children is challenging due to the risk of wide glucose fluctuations and their long-term consequences. The aim of this study was to compare the use of Medtronic 640G and off-label use of Tandem Basal IQ in children with T1D younger than 6 years of age.

Methods

Twentyone children (mean age 3 years) were started on either 640G (n=11) or Tandem Basal IQ (n=10) at onset and pump/sensor data was downloaded after 3 months. Parents of children started on Tandem signed an informed consent. Mann-Whitney non-parametric U test was used to assess differences in glucometrics between group.

Results

Glucometric parameters of 640G vs Tandem useres were respectively: TIR 75% vs 63%, TBR 2.4% vs 3%, TAR 21.6% vs 34%, CV 32 vs 38. Mean insulin dose was 0.4U/kg/die in the 640G group and 0.7U/kg/die in the Tandem group. Differences in glucose distributions were all statistically significant except for TBR. No episoides of severe hypoglycemia or DKA were reported.

Conclusions

Both pumps allowed these young children to obtain good glucose control. However, Medtronic 640G achieved significantly better glucose distributions, although this may be partially explained by the lower daily insulin needs in this group. Our data suggests that the use of Tandem Basal IQ in children <6 years is safe, feasible and may be a valid alternative to other systems in young children in whom also few capillary glucose calibrations may be challenging. Broader prospective studies in this delicate population are required to confirm our results.

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ORAL PRESENTATION SESSION

FACTORS ASSOCIATED WITH IMPROVEMENT IN DIABETES-RELATED DISTRESS IN PEOPLE LIVING WITH TYPE 1 DIABETES WITH FREESTYLE LIBRE -ASSOCIATION OF BRITISH CLINICAL DIABETOLOGISTS (ABCD) STUDY

Abstract

Background and Aims

We have recently shown that use of FSL is associated with improvement in diabetes-related distress (DDS) in people with T1D. The objective of this study was to identify factors associated with improvement in DDS following the use of FSL.

Methods

The study was performed using data from the ABCD nationwide FreeStyle Libre audit. We collected diabetes-related distress scores at baseline and follow up (two-item diabetes distress screening instrument, ‘feeling overwhelmed by the demands of living with diabetes’ and ‘feeling that I am often failing with my diabetes routine’DDS2). An average item score of ≥3 (moderate distress) discriminated high from low-distressed subgroups. We used an unsupervised gradient boosting machine learning model (GBM) to identify the relative influence (RI) of post-FSL use on two components of DDS. Since the two components were correlated, we only present the factors associated with the change in DDS1 following FSL use.

Results

The study included 4,588 people living with T1D who had baseline and post-FSL DDS score and consisted of 48.6% female, with baseline, and post FSL HbA1c of 67.6(±16.02)) and 62.9 (±14.02) mmol/l and a baseline and post FSL DDS of 2.8(±1.4) and 2.2(±1.9) respectively. In the GBM model, improvement in the GOLD score (RI=42.2), and HbA1c with FSL use (RI=19.4), post-FSL HbA1c (RI=13.8) and the greater number of FSL scans per day (RI=10.07) were associated post FSL reduction in DDS.

Conclusions

Improvement in hypoglycaemia awareness, glycaemic control and engagement with FSL is associated with improved DDS in people living with T1D.

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