Welcome to the ATTD 2022 Interactive Program

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Displaying One Session

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120

THE EFFECT OF GLUCAGON ON LOCAL SUBCUTANEOUS BLOOD FLOW IN HEALTHY VOLUNTEERS; A PROOF-OF-CONCEPT STUDY

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:00 - 11:08

Abstract

Background and Aims

The subcutaneous tissue is the main site for insulin replacement therapy and continuous glucose monitoring for people with diabetes mellitus type 1. However, the delay in both insulin absorption and glucose sensing prevents strict and automated glucose control. A way of minimising these delays would be to increase the local blood flow. We have investigated the vasodilative properties of glucagon in this proof-of-concept study.

Methods

Twenty-two healthy subjects received subcutaneous injections of 0.1 mg, 0.01 mg glucagon (Glucagon, Novo Nordisk, Denmark), and saline on the abdomen. Blood flow was measured by a laser doppler blood flowmeter for 35 minutes after the injections.

Results

Injection of 0.1 mg glucagon resulted in a significant increase in blood flow compared with baseline for all time intervals. Significant increase was also observed after the 0.01 mg glucagon injection, except between two- and five-minutes post injection. The inter-individual variance was large and a third of the subjects did not show an apparent increase in local subcutaneous blood flow after the 0.1 mg glucagon injection.

Conclusions

This proof-of-concept study shows that glucagon increases the local subcutaneous blood flow on the abdomen of healthy subjects. If these results are transferrable to people with diabetes, micro-boluses of glucagon may potentially speed up the absorption of insulin and improve the performance of continuous glucose monitoring in the subcutaneous tissue and thereby enable stricter glucose control. However, the vasodilative effect of glucagon is not observed in all subjects.

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IMPACT OF X-RAY EXPOSURE FROM COMPUTED TOMOGRAPHY (CT) ON A WEARABLE INSULIN DELIVERY DEVICE

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:08 - 11:16

Abstract

Background and Aims

Wearable insulin delivery devices are popular among people living with diabetes. However, manufacturer’s instructions for use requires the device be removed during a radiological procedure, which adds cost and inconvenience since the device cannot be reused. The aim of this study was to investigate the impact of radiation exposure from a CT scanner on the functionality and integrity of a wearable insulin delivery device.

Methods

One-hundred and sixty Omnipod DASH® Pods (Insulet, Acton, MA) were evenly divided into 4 groups: 1) control group (not irradiated); 2) typical exposure group (within a radiation field of a CT scan for an average patient size); 3) high exposure group (4x typical exposure); 4) scatter radiation group (indirect exposure outside the radiation field used for the high exposure group). The devices were placed on the abdomen (for direct exposure) and shoulder (for scatter radiation) regions of an anthropomorphic torso phantom (see Figure below). The functionality and integrity testing includes communication (activation, deactivation, and status update) and insulin delivery (basal delivery, bolus delivery, suspension and resume).

figure1.jpg

Results

All Pods passed the functionality and integrity tests, except for one from the scatter radiation group which alarmed during testing. An investigation identified the alarm was due to an occlusion in the insulin delivery path, not caused by radiation exposure.

Conclusions

Radiation exposures (direct or indirect) from a CT scanner had no impact on the functionality and integrity of Omnipod DASH Pods, even under the direct irradiation from 4x typical exposure in the abdomen/pelvis region.

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EXTENDING THE LIFE OF INSULIN PUMP INFUSION SETS BY REMOVAL OF PHENOLIC EXCIPIENTS FROM INSULIN INJECTION

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:16 - 11:24

Abstract

Background and Aims

Insulin pump wearers frequently experience the phenomenon of unexplained hyperglycemia or “site loss,” where injections have minimal effect and are thus “lost”. Site loss is typically observed between 48 and 72 hours of wear. We believe that one key reason for this lack of performance is the presence of toxic phenolic compounds in the insulin formulation, which are added in all commercially available insulin analogs as preservatives and stabilizers. Specifically, there are studies showing that exposure to phenolic excipients induces proinflammatory response and cell death, stimulating additional inflammatory processes, which decrease insulin efficacy overall. Therefore, insulin efficacy and infusion site longevity may be improved by removing phenolic excipients in the infusion set immediately before injecting into the body.

Methods

Phenolic excipients were removed from insulin in the cannula through electrochemical oxidization. As a proof of concept, we used a commercially available carbon screen printing electrode. We modified the electrode surface with bio-compatible polyelectrolyte to prevent passivation of the electrode and ensure the integrity of insulin.

Results

Our chronoamperometry results showed that current decay reduced from 91.4% to 46.8% on a polyelectrolyte modified electrode comparing to bare electrode, indicating an improved resistance to passivation. 32% phenol was removed from solution in one hour on a modified electrode, whereas only 4.4% phenol was removed on a bare electrode. HPLC data confirmed that insulin remained intact through electrochemical removal of phenols.

Conclusions

Electro-oxidization of phenolic compound on polyelectrolyte modified surfaces can remove these preservatives while maintaining the integrity of insulin.

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GLYCEMIC OUTCOMES BY AGE AND PREVIOUS INSULIN DELIVERY METHOD IN CONTROL-IQ TECHNOLOGY USERS: 9 MONTHS OF CLIO STUDY DATA

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:24 - 11:32

Abstract

Background and Aims

The Control-IQ Observational (CLIO) Study is currently an ongoing IRB-approved, single-arm, longitudinal study evaluating real-world use of Tandem’s t:slim X2 insulin pump with Control-IQ technology in people with T1D (PWT1D). Previous publications from CLIO have shown glycemic improvements in ethnically diverse groups of PWT1D after 3 months of using Control-IQ technology.

Methods

We evaluated relationships between glycemic metrics, participants’ age, and previous insulin delivery method at 9 months after CLIO study start. Participants (N=1913) who had uploaded at least 21 days of Control-IQ feature usage data to Tandem’s t:connect® web application (US only) and had ≥75% CGM use were included in the analysis. Impact of baseline factors on sensor glycemic outcomes were analyzed. Differences between baseline HbA1c and GMI were compared using a Wilcoxon test.

Results

Baseline HbA1c (self-reported) for the overall sample was 7.4% (median, IQR=6.8-8.3). At post with Control-IQ technology, GMI reflected significant glycemic improvement (7.06%, IQR=6.75-7.42). Previous MDI users demonstrated 71.23% TIR (61.29-81.16) and overnight TIR=75.26% (64.62-84.5) while previous pump users showed TIR=70.43% (61.27-78.67) and overnight TIR=76.39(65.46-85.12). Participants aged ≥65 years, transitioning from prior pump therapy showed the lowest GMI (median=6.87, IQR=6.62-7.17) and the highest sensor time in range (TIR) (77.94%, IQR=69.29-83.8). Younger participants although reporting higher HbA1c at baseline (6–13-year-old, 7.8% (IQR=7.1-8.6); 14–17-year-old, 8% (IQR=7.1-9)) also showed significant glycemic improvements after 9 months of using Control-IQ technology (GMI=7.4 and 7.35, respectively).

table 1.png

Conclusions

Long-term use of Control-IQ technology demonstrated improved glycemic metrics irrespective of participants’ age and previous insulin delivery method.

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CHARACTERIZATION OF CHANGES AT INSULIN PUMP INFUSION SITES IN T1D: THE DERMIS STUDY

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:32 - 11:40

Abstract

Background and Aims

There are no studies evaluating the human skin changes related to continuous subcutaneous insulin infusion (CSII). The aim of this study is to characterize changes at CSII sites in patients with T1D using traditional histopathology and novel non-invasive skin imaging (optical coherence tomography; OCT).

Methods

31 patients with T1D were enrolled. Demographics, diabetes data and blood samples were obtained. OCT assessments and punch biopsies were collected at: 1) current and 2) prior CSII sites and 3) control (never-used) site. Histologic changes were visually scored.

Results

Table 1 shows population characteristics. CSII sites showed a significant increase in epidermal thickness, inflammation, fibrin, fat necrosis and vascularity compared to control sites. OCT demonstrated a significant difference in vascular density (VD) and optical attenuation coefficient (OAC) between CSII and control sites (Table 2). No significant differences were observed between prior and current CSII sites.

Table 1

Male(n)

10

Female(n)

21

Age (Years, Mean±SD)

47±17.5

Diabetes Diagnosis (Years, Mean±SD)

30±15.9

Insulin pump use (Years, Mean±SD)

15.7±11.7

HbA1c (mg/dL, Mean±SD)

6.66±0.79

Table 2

Current

Prior

Control

Histology

Epidermal thickness*

0.075±0.031

0.071±0.026

0.042±0.011

Dermal thickness

4.26±0.82

3.83±1.04

3.76±0.79

Fibrosis*

1.63±0.75

1.54±0.68

0.5±0.62

Inflammation*

1.77±0.76

1.75±0.95

0.27±0.57

Fibrin*

1.18±1.09

1.53±1.00

0.27±0.57

Vascularity*

1.43±0.88

1.36±0.81

0.57±0.72

Fat necrosis*

1.30±0.68

1.04±0.89

0.13±0.36

OCT

VD*

0.476±0.036

0.445±0.021

0.343±0.025

OAC*

1.23±0.35

1.48±0.43

2.08±0.34

Thickness

142.2±19.9

155.4±13.7

144.1±15.5

*p-value (Kruskal-Wallis rank sum test) <0.001

Conclusions

Significant changes in the skin were observed by both histology and OCT at CSII sites. The impact of these changes on CSII function warrants further study.

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INEQUALITIES AND HETEROGENEITY IN ACCESSING DIABETES-RELATED TECHNOLOGY: DETERMINANTS OF UPTAKE AND ACCESS TO INSULIN PUMP THERAPY BY ADULTS WITH TYPE 1 DIABETES IN IRELAND

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:40 - 11:48

Abstract

Background and Aims

Although continuous subcutaneous insulin infusion (CSII) therapy is recognized as effective and safe, its use remains heterogeneous globally and within countries. This study aimed to explore the determinants of uptake and access to insulin pump therapy by people with type 1 diabetes (PwD) in Ireland.

Methods

A multiphase mixed-methods research design was used. Quantitative (i) evidence on uptake of CSII (secondary data analysis of pharmacy claims data) and on availability of CSII (national survey of diabetes clinics), and qualitative (ii) exploration of the barriers and facilitators in accessing CSII [interviews with key stakeholders (health-care professionals-HCP, policy-makers etc.) and focus groups with PwD (from areas of low, medium and high uptake of CSII)] were synthesised using the Pillar Integration Process approach.

Results

In Ireland: 6.8% of adults with type 1 diabetes were using CSII in 2016 (range: 2% to 9.6%); one-third of diabetes clinics did not offer any type of CSII services; and less than half of clinics offered training to commence CSII. The synthesis of all findings (including qualitative: 21 interviews and 4 focus groups) provided the list of determinants: funding/reimbursement; dwelling location/availability in local clinics; structure of the health-service; capacity (resources/expertise); awareness/education; and impact of individual factors (PwD and HCP attitudes).

Conclusions

Despite the full reimbursement, local diversity in uptake and access to CSII was observed in Ireland. The results of this study can inform policy-makers, health-services planners, HCP and PwD on the complexity of the access to CSII and may help explain reasons for the variable uptake of CSII uptake worldwide.

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LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES IRRESPECTIVE OF BASELINE GLYCEMIC CONTROL AND PREVIOUS INSULIN DELIVERY METHOD WITH THE T:SLIM X2 PUMP WITH CONTROL-IQ TECHNOLOGY

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:48 - 11:56

Abstract

Background and Aims

Patient-reported outcomes (PROs) are essential when evaluating patients’ trust in their diabetes therapy and its long-term use. Previous publications from the Control-IQ Observational (CLIO) study (NCT04503174) have shown PRO improvements in people with type 1 diabetes (PWT1D) after three months of using Control-IQ technology.

Methods

We compared PROs at baseline (pre) and 6 months post Control-IQ technology use in CLIO participants. Repeated measures ANOVA was used to assess differences in PROs from pre to post.

Results

Sample included 2062 PWT1D. At baseline, 23% reported HbA1c ≥8.5%, and 63% were using a different insulin pump. After 6 months of Control-IQ technology (post), participants reported significant reduction in the perceived negative impact of diabetes on their diabetes-specific quality of life (mean=4.70 (SD=0.88) vs. 4.40 (1.05), p<0.001) with greatest improvement reported for “freedom to eat as you wish”. Significant improvement in satisfaction with insulin-delivery device (IDD) was noted at post, with participants reporting higher satisfaction with Control-IQ technology (8.84 (1.14) vs. their previous IDD (7.21 (1.97)) (p<0.001). Improved satisfaction was reported across all age groups (e.g., 6–12-year-old: 8.99 (1.01); 65+ years: 8.66 (1.33)). Additionally, reduced burden of diabetes was reported irrespective of previous IDD (MDI: 4.80 (1.85) vs. 3.15 (1.49); Pump users: 4.59 (1.81) vs. 3.10 (1.39); p<0.001) and baseline HbA1c (<8.5%: 4.90 (1.84) vs. 3.05 (1.35); ≥8.5%: 4.88 (1.86) vs. 3.29 (1.50); p<0.001).

Conclusions

Control-IQ technology users reported improved quality of life, reduced diabetes burden, and higher satisfaction with diabetes therapy irrespective of age, baseline HbA1c, and previous IDD.

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ULTRASOUND MEASURED VASCULARIZATION AND ECHOGENICITY IN THE SUBCUTIS – A PROSPECTIVE STUDY SHOWING SKIN REACTIONS TO DIABETES DEVICES IN PEDIATRIC PATIENTS WITH TYPE 1 DIABETES

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
11:56 - 12:04

Abstract

Background and Aims

Many pediatric Type 1 diabetic patients using continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) have skin issues (1). The aim was therefore to investigate subcutis (Sc) as a measure of underlying skin.

Methods

Ultrasound during first year after initiation of a new CSII or CGM showed echogenicity and pathologic vascularization of the Sc at CSII and CGM sites. Binomial Generalized Linear Mixed Models was applied to detect significant changes in vascularization and echogenicity over time.

Results

These preliminary data consist of 124 CGM-participants and 66 CSII-participants with respectively 43 and 15 who completed last visit. The figure shows the proportion of vascularization, hyper- and hypoechogenicity of the Sc. The frequency of hyperechogenicity was more than 50% at all visits. The frequency of vascularization of the Sc at the pump sites was 3% at baseline and 13 % after 12 months but without significant change (p=0.131). Sc changes were rare at CGM-sites. At the 12th month, mean HbA1c was 60.38 mmol/L and 48.4 mmol/L respectively for patients with and without hyperechogenicity at the pump site (p < 0.001).
figur til ul-abstract til attd.png

Conclusions

The frequency of hyperechogenic CSII sites were quite high at all visits and were significantly associated with high HbA1c after 12 months. Vascularization were seen in more than 10 % of the CSII patients after 12 months. These findings suggest that hyperechogenicity primary occurs at pump and not sensor sites and that it might help blood sugar control if a method to reduce hyperechogenicity was found.

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THE EFFECT OF A SKIN CARE INTERVENTION ON FREQUENCIES OF SKIN PROBLEMS IN PEDIATRIC PATIENTS SIX MONTHS AFTER INITIATION OF DIABETES DEVICES

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
12:04 - 12:12

Abstract

Background and Aims

Pediatric patients with type 1 diabetes are increasingly using devices to treat their disease. Unfortunately, many evolve skin problems, and especially eczema due to contact with these devices. This study investigated the effect of skin care in preventing skin problems in pediatric patients due to contact with diabetes devices.

Methods

A cluster-controlled interventional study of 119 pediatric patients was done after initiation of a diabetes device. The intervention consisted of information on proper skin care as well as delivery of a 70%-lipid lotion for daily use. Patients were seen every third month. Data on skin problems due to devices were obtained by visual inspection as well as interview. Chi-squared and Fischer Exact test were used as statistics.

Results

figure, attd2022, 611.pngAfter six months, 30% and 32% of the patients in intervention and control group, respectively, had self-reported skin problems since last visit. Visible skin reactions recognized by trained personnel were seen in 27% of pump patients and 16% of sensor patients at six months, and the distribution of eczema, wound and scar in groups are shown in the figure. No significant differences were found among both self-reported and visible skin reactions in the intention-to-treat analysis but revealed tendencies towards protective effect of intervention.

Conclusions

After six months of device use, 30% of 119 described skin reactions and most of the reactions were seen in pump patients. After six months, the skin care intervention does not significantly prevent skin problems overall, but longer follow-up is needed.

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MULTIPLE BASAL INFUSION RATES IN OPEN-LOOP INSULIN DELIVERY SYSTEMS: IS THERE METABOLIC BENEFIT?

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
12:12 - 12:20

Abstract

Background and Aims

The favorable impact of using more than 4 basal infusion rates (BIR) in open-loop delivery CSII systems remains unknown.

The aim of this work was to evaluate glycemic control according to the number of daily BIR in T1D patients using CSII.

Methods

Cross-sectional study of patients treated with CSII for ≧6 months, using a flash glucose monitoring system. Patients were divided into groups 1 (G1) and 2 (G2), with ≦4 and >4 BIR/24h respectively, and compared according to HbA1c, TIR, TAR, TBR, GMI, coefficient of variation (CV) and hypoglycemia. Regression models were performed.

Results

We included 99 patients. Median (IQR) age was 30(17) years, with 28(70) months of CSII use. The number of different BIR were 4(3): 3(2) in G1 (n=55) and 6(2) in G2 (n=44). Groups were similar in age, sex, scholarity, weight and insulin analogue used. G2 had longer disease duration (14.5(12) vs 12(14) years, p=0.016), longer CSII use (51(77) vs 19.5(48) months, p<0.001) and higher basal total daily dose/Kg (0.30(0.13) vs 0.26(0.11) U/kg, p=0.006). No significant differences were found regarding HbA1c, median glucose, GMI, TIR, TAR and CV. G2 patients had more hypoglycemia (47.4 vs 21.3%, p=0.019), more asymptomatic hypoglycemia (16.7 vs 1.8%, p=0.040) and higher TBR (6(9) vs 4(5)%, p=0.049). After adjusting for confounders, G1 maintained a lower risk of asymptomatic hypoglycemia (OR 0.06, p= 0.035, 95% CI 0.004;0.819).

Conclusions

Programming open-loop CSII devices with >4 BIR didn’t improve metabolic control, represented a risk factor for hypoglycemia and was an independent predictor of asymptomatic hypoglycemia.

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YOUTH WITH TYPE 1 DIABETES BENEFIT FROM EARLY CONTINUOUS GLUCOSE MONITORING INITATION IRRESPECTIVE OF DIABETIC KETOACIDOSIS AT DIAGNOSIS: 4T PILOT STUDY RESULTS

Session Type
Oral Presentations Session
Date
Sat, 30.04.2022
Session Time
11:00 - 12:30
Room
Hall 120
Lecture Time
12:20 - 12:28

Abstract

Background and Aims

The 4T pilot study offered continuous glucose monitoring (CGM) to youth with type 1 diabetes (T1D) within 1 month of diagnosis. Diabetic ketoacidosis (DKA) at diagnosis is associated with short- and long-term complications. Our aim was to determine the impact of the 4T pilot study on hemoglobin A1c (HbA1c) levels in youth who presented in DKA versus without DKA across 12 months.

Methods

In the 4T pilot study (n=135), HbA1c levels were compared in youth that presented in DKA (n=67) at T1D diagnosis versus youth without DKA (n=68) at diagnosis. HbA1c levels were evaluated using a locally estimated scatter plot smoothing (LOESS).

Results

Youth with DKA at diagnosis had a higher starting HbA1c at diagnosis (12.6 ± 2.0%) compared to youth without DKA (11.9 ± 2.2%) at diagnosis (Figure 1). Youth with DKA at diagnosis also had an earlier and higher HbA1c (nadir 6.9% at 4 months) than the group with no DKA at diagnosis (nadir 6.3% at 5 months). Although HbA1c levels had a slight drift upward in the group with DKA at diagnosis at 12-months, the overall HbA1c trajectory remained steady across 12 months post-diagnosis in both groups.

Conclusions

In the 4T program, we observed an improvement in HbA1c trajectories for youth, irrespective of DKA presentation at diagnosis. However, these data highlight the potential need for additional support for youth that present in DKA at diagnosis to achieve recommended clinical HbA1c targets and programs to diagnose T1D before DKA develops.

fig_loess_hba1c_2021-11-23_zaharieva.png

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