Impact of X-Ray Exposure From Computed Tomography on Wearable Insulin Delivery Devices.

BACKGROUND: To investigate the impact of radiation exposure from a computed tomography (CT) scanner on the functional integrity of a wearable insulin delivery system. METHODS: A total of 160 Omnipods and four personal diabetes managers (PDMs) were evenly divided into four groups: (1) control group (no radiation exposure), (2) typical radiation exposure group, (3) 4× typical radiation exposure group, and (4) scatter radiation group. Pods were attached to an anthropomorphic torso phantom on the abdomen (direct irradiation) or shoulder (scatter radiation) region. A third-generation dual-source CT scanner was used to scan the pods using either a typical exposure (used for routine CT abdominal study of a median size patient) or 4× typical exposure. A manufacturer-recommended 20-step functionality test was performed for all 160 Omnipods. RESULTS: The radiation dose (measured in volume CT Dose index) was 16 mGy for a typical exposure, and 64 mGy for 4× typical exposure. The scatter radiation is less than 0.1 mGy. All Pods passed the functionality test except one pod in the scatter radiation group, which sounded an alarm due to occlusion. The blockage to the fluid was due to a kink in the soft cannula, a mechanical issue not caused by the radiation exposure. CONCLUSIONS: This study suggests X-ray exposure levels used in radiological imaging procedures do not negatively impact the functional integrity of Omnipods. This finding may support the potential for the manufacturer to remove the warning that patients should remove the Pod for X-ray imaging procedures, which will have a huge impact on patient care.

Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy.

OBJECTIVE: Automated insulin delivery (AID) has rarely been studied in adults with type 2 diabetes. We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter outpatient trial. RESEARCH DESIGN AND METHODS: Participants previously were using either basal-only or basal-bolus insulin injections, with or without the use of a continuous glucose monitor (CGM), and had a baseline HbA1c ≥8% (≥64 mmol/mol). Participants completed 2 weeks of CGM sensor data collection (blinded for those not previously using CGM) with their standard therapy (ST), then transitioned to 8 weeks of AID. Participants who previously used basal-only injections used the AID system in manual mode for 2 weeks before starting AID. Antihyperglycemic agents were continued at clinician discretion. Primary safety outcomes were percentage of time with sensor glucose ≥250 mg/dL and <54 mg/dL during AID. Additional outcomes included HbA1c and time in target range (TIR) (70-180 mg/dL). RESULTS: Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA1c of 9.4% ± 0.9% (79 ± 10 mmol/mol), and diabetes duration of 19 ± 9 years. Percentage of time with sensor glucose ≥250 mg/dL decreased with AID by 16.9% ± 16.2% (P < 0.0001), whereas percentage of time at <54 mg/dL remained low during both ST and AID (median [interquartile range] 0.0% [0.00%, 0.06%] vs. 0.00% [0.00%, 0.03%]; P = 0.4543). HbA1c (± SD) decreased by 1.3% ± 0.7% (14 ± 8 mmol/mol; P < 0.0001) and TIR increased by 21.9% ± 15.2% (P < 0.0001) without a significant change in total daily insulin or BMI with AID. CONCLUSIONS: Findings from this feasibility trial of AID in adults with type 2 diabetes with suboptimal glycemic outcomes justify further evaluation of this technology in this population.

Improvements in Glycemic Outcomes in 4738 Children, Adolescents, and Adults with Type 1 Diabetes Initiating a Tubeless Insulin Management System.

INTRODUCTION: Despite recent advances in diabetes technology, most people living with type 1 diabetes mellitus (T1D) are unable to meet glycemic targets. Real-world evidence can provide insight into outcomes achieved with specific treatment devices when used in clinical practice. The aim of this study was to analyze real-world outcomes collected from a large cohort of people living with T1D and initiating treatment with the Omnipod DASH System. METHODS: In this retrospective observational study, real-world outcomes were analyzed from a database of information collected from people with T1D initiating the Omnipod DASH System. Information in the database was either taken directly from the patient's medical record or self-reported if medical records were unavailable. The primary outcome was change in glycated hemoglobin (HbA1c) from baseline (before initiation) to 3 months after initiation. Secondary outcomes were changes in total daily dose of insulin (TDD) and self-reported frequency of hypoglycemic events (< 70 mg/dL). Results are separated for the adult (≥ 18 years, N = 3341) and pediatric (< 18 years, N = 1397) cohorts. RESULTS: The change in HbA1c from baseline was - 0.9 ± 1.6% ( - 10 ± 18 mmol/mol; p < 0.0001) in adults and - 0.9 ± 2.0% ( - 10 ± 22 mmol/mol; p < 0.0001) in the pediatric cohort. For those previously using multiple daily injections, HbA1c decreased by - 1.0 ± 1.7% ( - 11 ± 19 mmol/mol) in adults and - 1.0 ± 2.1% ( - 11 ± 23 mmol/mol) in the pediatric cohort (both p < 0.0001). Hypoglycemic events decreased in adults from 2.9 to 1.3 episodes per week ( - 1.6 ± 3.2 events/week; p < 0.0001), and in the pediatric cohort from 2.8 to 1.5 episodes per week ( - 1.3 ± 2.7 events/week; p < 0.0001). In adults, TDD decreased by 19.9% (p < 0.0001), and it remained stable in the pediatric cohort (p > 0.05). CONCLUSIONS: Real-world outcomes from this large cohort of people initiating therapy with the Omnipod DASH System showed significant improvement in HbA1c and a substantial reduction in hypoglycemic events after 3 months of use.

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System.

AIMS: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System. METHODS: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses. RESULTS: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen). CONCLUSIONS: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D. CLINICAL TRIALS REGISTRATION NUMBER: NCT04196140.

Improved glycemic control in 3,592 adults with type 2 diabetes mellitus initiating a tubeless insulin management system.

AIMS: To compare glycemic outcomes in adults with type 2 diabetes mellitus (T2DM) before and 90 days after initiating Omnipod® or Omnipod DASH® Insulin Management Systems. METHODS: In this retrospective observational study (N = 3,592) change in HbA1c level, total daily dose (TDD) of insulin (n = 3,053), and frequency of self-reported hypoglycemic events (HE, <70 mg/dL, n = 2,922) were assessed overall and by prior treatment modality (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)), age group, and baseline HbA1c category. RESULTS: Change (mean ± SD) in HbA1c was -1.3 ± 1.7% [-14 ± 19 mmol/mol] overall, -1.4 ± 1.7% [-15 ± 19 mmol/mol] for prior MDI users, and -0.9 ± 1.5% [-10 ± 16 mmol/mol] for prior CSII users (p<0.0001). The percentage of patients with HbA1c ≥9% [≥75 mmol/mol] decreased (49% to 19%), and with HbA1c <7% [<53 mmol/mol] increased (10% to 22%) (p<0.0001). Prior therapy, age, and baseline HbA1c category were factors affecting change in HbA1c (p<0.05). Reductions in TDD (overall, -33 ± 52U, p<0.0001) and HE per week (overall, -0.5 ± 2.0, p<0.0001), were seen regardless of prior treatment, age, or baseline HbA1c. CONCLUSIONS: Omnipod System use was associated with statistically and clinically meaningful reductions in HbA1c, TDD, and HE compared to prior treatments in T2DM.

Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Adults With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion.

OBJECTIVE: Exercising while fasted with type 1 diabetes facilitates weight loss; however, the best strategy to maintain glucose stability remains unclear. RESEARCH DESIGN AND METHODS: Fifteen adults on continuous subcutaneous insulin infusion completed three sessions of fasted walking (120 min at 45% VO2max) in a randomized crossover design: 50% basal rate reduction, set 90 min pre-exercise (-90min50%BRR); usual basal rate with carbohydrate intake of 0.3 g/kg/h (CHO-only); and combined 50% basal rate reduction set at exercise onset with carbohydrate intake of 0.3 g/kg/h (Combo). RESULTS: Combo had a smaller change in glucose (5 ± 47 mg/dL) versus CHO-only (-49 ± 61 mg/dL, P = 0.03) or -90min50%BRR (-34 ± 45 mg/dL). The -90min50%BRR strategy produced higher ß-hydroxybutyrate levels (0.4 ± 0.3 vs. 0.1 ± 0.1 mmol/L) and greater fat oxidation (0.51 ± 0.2 vs. 0.39 ± 0.1 g/min) than CHO-only (both P < 0.05). CONCLUSIONS: All strategies examined produced stable glycemia for fasted exercise, but a 50% basal rate reduction, set 90 min pre-exercise, eliminates carbohydrate needs and enhances fat oxidation better than carbohydrate feeding with or without a basal rate reduction set at exercise onset.

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes.

Background: The objective of this study was to assess the safety and effectiveness of the first commercial configuration of a tubeless automated insulin delivery system, Omnipod® 5, in children (6-13.9 years) and adults (14-70 years) with type 1 diabetes (T1D) in an outpatient setting. Materials and Methods: This was a single-arm, multicenter, prospective clinical study. Data were collected over a 14-day standard therapy (ST) phase followed by a 14-day hybrid closed-loop (HCL) phase, where participants (n = 36) spent 72 h at each of three prespecified glucose targets (130, 140, and 150 mg/dL, 9 days total) then 5 days with free choice of glucose targets (110-150 mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70-180 mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events. Results: Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%, P < 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%, P < 0.01), a 130 mg/dL target (61.5% ± 7.7%, P < 0.01), and a 140 mg/dL target (64.8% ± 11.6%, P < 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%, P < 0.05), compared to the ST phase (children: 51.0% ± 13.3% and adults: 65.6% ± 15.7%). There were no serious device-related adverse events reported during the HCL phase, nor were there episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150 mg/dL for 14 days at home in children and adults with T1D.

Improved Open-Loop Glucose Control With Basal Insulin Reduction 90 Minutes Before Aerobic Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion.

OBJECTIVE: To reduce exercise-associated hypoglycemia, individuals with type 1 diabetes on continuous subcutaneous insulin infusion typically perform basal rate reductions (BRRs) and/or carbohydrate feeding, although the timing and amount of BRRs necessary to prevent hypoglycemia are unclear. The goal of this study was to determine if BRRs set 90 min pre-exercise better attenuate hypoglycemia versus pump suspension (PS) at exercise onset. RESEARCH DESIGN AND METHODS: Seventeen individuals completed three 60-min treadmill exercise (∼50% of VO2peak) visits in a randomized crossover design. The insulin strategies included 1) PS at exercise onset, 2) 80% BRR set 90 min pre-exercise, and 3) 50% BRR set 90 min pre-exercise. RESULTS: Blood glucose level at exercise onset was higher with 50% BRR (191 ± 49 mg/dL) vs. 80% BRR (164 ± 41 mg/dL; P < 0.001) and PS (164 ± 45 mg/dL; P < 0.001). By exercise end, 80% BRR showed the smallest drop (-31 ± 58 mg/dL) vs. 50% BRR (-47 ± 50 mg/dL; P = 0.04) and PS (-67 ± 41 mg/dL; P < 0.001). With PS, 7 out of 17 participants developed hypoglycemia versus 1 out of 17 in both BRR conditions (P < 0.05). Following a standardized meal postexercise, glucose rose with PS and 50% BRR (both P < 0.05), but failed to rise with 80% BRR (P = 0.16). Based on interstitial glucose, overnight mean percent time in range was 83%, 83%, and 78%, and time in hypoglycemia was 2%, 1%, and 5% with 80% BRR, 50% BRR, and PS, respectively (all P > 0.05). CONCLUSIONS: Overall, a 50-80% BRR set 90 min pre-exercise improves glucose control and decreases hypoglycemia risk during exercise better than PS at exercise onset, while not compromising the postexercise meal glucose control.

Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes.

Background: Real-time continuous glucose monitoring (CGM) devices help detect glycemic excursions associated with exercise, meals, and insulin dosing in patients with type 1 diabetes (T1D). However, the delay between interstitial and blood glucose may result in CGM underestimating the true change in glycemia during activity. The purpose of this study was to examine CGM discrepancies during exercise and the meal postexercise versus self-monitoring of blood glucose (SMBG). Methods: Seventeen adults with T1D using insulin pump therapy and CGM completed 60 min of aerobic exercise on three occasions. A standardized meal was given 30 min postexercise. SMBG was measured during exercise and in recovery using OmniPod® Personal Diabetes Manager (PDM; Insulet, Billerica, MA) with built-in glucose meter (FreeStyle; Abbott Laboratories, Abbott Park, IL), while CGM was measured with Dexcom G4® with 505 algorithm (n = 4) or G5® (n = 13), which were calibrated with subjects' own PDM. Results: SMBG showed a large drop in glycemia during exercise, while CGM showed a lag of 12 ± 11 (mean ± standard deviation) minutes and bias of -7 ± 19 mg/dL/min during activity. Mean absolute relative difference (MARD) for CGM versus SMBG was 13 (6-22)% [median (interquartile range)] during exercise and 8 (5-14)% during mealtime. Clarke error grids showed CGM values were in zones A and B 94%-99% of the time for SMBG. Conclusion: In summary, the drop in CGM lags behind the drop in blood glucose during prolonged aerobic exercise by 12 ± 11 min, and MARD increases to 13 (6-22)% during exercise as well. Therefore, if hypoglycemia is suspected during exercise, individuals should confirm glucose levels with a capillary glucose measurement.