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.
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).
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.
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.
The objective of this study was to assess the safety and performance of the Omnipod
personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type ...1 diabetes (T1D) under free-living conditions using an investigational device.
A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 years with A1C <10.0% using insulin pump therapy or multiple daily injections. Meals during HCL were unrestricted, with boluses administered per usual routine. There was daily physical activity. The primary endpoints were percentage of time with sensor glucose <70 and ≥250 mg/dL.
Participants were 11 adults, 10 adolescents, and 15 children aged (mean ± standard deviation) 28.8 ± 7.9, 14.3 ± 1.3, and 9.9 ± 1.0 years, respectively. Percentage time ≥250 mg/dL during HCL was 4.5% ± 4.2%, 3.5% ± 5.0%, and 8.6% ± 8.8% per respective age group, a 1.6-, 3.4-, and 2.0-fold reduction compared to ST (
= 0.1,
= 0.02, and
= 0.03). Percentage time <70 mg/dL during HCL was 1.9% ± 1.3%, 2.5% ± 2.0%, and 2.2% ± 1.9%, a statistically significant decrease in adults when compared to ST (
= 0.005,
= 0.3, and
= 0.3). Percentage time 70-180 mg/dL increased during HCL compared to ST, reaching significance for adolescents and children: HCL 73.7% ± 7.5% vs. ST 68.0% ± 15.6% for adults (
= 0.08), HCL 79.0% ± 12.6% vs. ST 60.6% ± 13.4% for adolescents (
= 0.01), and HCL 69.2% ± 13.5% vs. ST 54.9% ± 12.9% for children (
= 0.003).
The Omnipod personalized MPC algorithm was safe and performed well over 5 days and 4 nights of use by a cohort of participants ranging from youth aged ≥6 years to adults with T1D under supervised free-living conditions with challenges, including daily physical activity and unrestricted meals.
Introduction and Objective: Assess Omnipod 5 System’s efficacy in managing glycemia during activity, comparing ‘Activity Feature’ initiated 30 (AF-30) or 60 min (AF-60) before exercise to automated ...delivery (Auto). Methods: In this three-way crossover, 50 people with T1D (age 30±15 years, BMI 24.7±4.1 kg/m2, HbA1c 7.5±1.0%, and T1D duration 16±11 years) underwent a 70 min activity session (60 min exercise, 5 min rest at 20 and 45 min), 3hrs post-bolus, under each condition (Auto, AF-30, and AF-60). Pre-activity glucose was 90-200mg/dL. Up to 16g of carbs were provided if glucose was <90mg/dL pre activity or <70mg/dL during activity. Metrics were assessed using generalized estimating equations. Results: Insulin delivery was decreased before and during activity for AF-30 and AF-60 vs Auto (p<0.05, Table). During activity, AF-30 and AF-60 had smaller decreases in glucose, which was significant for Auto vs AF-30, p=0.03. Carb consumption during activity was higher for Auto vs AF-30 (p=0.02) and AF-60 (p=0.04). Time to hypo was delayed by 10 min (16% longer) in AF-30 and AF-60 relative to Auto. Conclusion: Enabling Activity Feature 30 min before activity with Omnipod 5 may effectively mitigate glucose declines. Regardless, carb consumption may be necessary to minimize hypo risk during 60 min of exercise. Disclosure L.V. Turner: None. J.L. Sherr: Consultant; Medtronic. Advisory Panel; Medtronic, Insulet Corporation. Speaker's Bureau; Insulet Corporation. Advisory Panel; Vertex Pharmaceuticals Incorporated, MannKind Corporation, StartUp Health T1D Moonshot, Bigfoot Biomedical, Inc., Cecelia Health. Speaker's Bureau; Zealand Pharma A/S. D.P. Zaharieva: Research Support; Leona M. and Harry B. Helmsley Charitable Trust. Advisory Panel; Dexcom, Inc. Research Support; Insulet Corporation. Speaker's Bureau; Dexcom, Inc. Research Support; International Society for Pediatric and Adolescent Diabetes. Board Member; Juvenile Diabetes Research Foundation (JDRF). J.D. Baran: None. B.W. Bode: Research Support; Omnipod. Speaker's Bureau; Omnipod. Research Support; Medtronic. Advisory Panel; Medtronic. S.A. Brown: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Insulet Corporation, Tolerion, Roche Diagnostics. S. Bzdick: None. M. Church: None. D.W. Hansen: None. R.S. Kingman: None. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc. S.L. Stone: None. T. Vienneau: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. L.M. Huyett: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. B. Dumais: None. T.T. Ly: Employee; Insulet Corporation. M.C. Riddell: Consultant; Eli Lilly and Company. Speaker's Bureau; Novo Nordisk. Advisory Panel; Supersapiens. Consultant; Dexcom, Inc. Speaker's Bureau; Sanofi. Advisory Panel; Zealand Pharma A/S. Speaker's Bureau; Dexcom, Inc. Stock/Shareholder; Zucara Therapeutics. Funding This study was funded by Insulet Corporation.
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.
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 (
= 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.
Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%,
< 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%,
< 0.01), a 130 mg/dL target (61.5% ± 7.7%,
< 0.01), and a 140 mg/dL target (64.8% ± 11.6%,
< 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%,
< 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.
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.
As there is a pressing need for better treatment options for type 2 diabetes (T2D) , it is crucial to explore new technologies such as automated insulin delivery (AID) in this population. Little is ...known about how successful these systems will be in T2D, especially over a longer duration of use. The safety and practicability of the Omnipod 5 AID System in adults with T2D was previously demonstrated during an 8-week outpatient feasibility trial. Those completing this initial study were invited to continue system use for an additional 26 weeks to assess longer-term efficacy. We present results from the first 13-week follow-up assessment of the extension study. In the initial study, adults with T2D (A1C >8%) previously on either basal-only (n=12) or basal-bolus insulin injections (n=12) , with or without CGM, used AID for 8 weeks following 14 days of their standard therapy. Those participating in the extension study continued AID use, and A1C was measured again after 13 weeks (21 weeks of total AID use) . Efficacy was assessed by change in A1C from baseline. Most participants (N=22, 92%) continued into the extension phase. Two of these participants had completed the initial study before the extension study was available but were allowed to re-join, resulting in a 2-4-month return to their standard therapy before resuming AID. Participants were aged (mean±SD) 61±8y with BMI 33.9±4.4kg/m2, diabetes duration 19±9y, and baseline A1C 9.4±0.9% (range: 8.1-11.7%) . Mean A1C decreased to 8.0±0.7% after 8 weeks of AID (p<0.05) . After an additional 13 weeks of use, mean A1C was 7.7±0.7%, corresponding to an overall decrease of 1.6±1.0% from baseline to 21 weeks of total use (p<0.05) . There were no episodes of severe hypoglycemia during the study. The continued improvement in A1C with longer duration of AID use with the Omnipod 5 System demonstrates a durable and clinically meaningful benefit for participants with previously sub-optimal glycemic control outcomes on injection insulin therapy.
Disclosure
G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker's Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. A.L.Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. B.Dumais: Employee; Insulet Corporation. T.Vienneau: Employee; Insulet Corporation, Stock/Shareholder; Dexcom, Inc., GlaxoSmithKline plc., Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. T.T.Ly: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation.
Funding
This study was funded by Insulet Corporation.
Customization of glucose targets in hybrid closed-loop (HCL) systems is important to enable tailored glucose management and safe onboarding across a wide range of users. The safety and performance of ...the Omnipod HCL personalized model predictive control (MPC) algorithm were assessed with a lower target of 110mg/dL for the first time in children aged 2-12y with type 1 diabetes (T1D) using an investigational device.
Participants with A1C<10.0% completed a 72-96h HCL study conducted in a supervised free-living hotel setting. At HCL start, the glucose target was 120mg/dL, and was lowered to 110mg/dL after 24-48h. There were 1-2 missed lunch boluses, high fat meals, and daily exercise.
Participants (n=12) were (mean±SD): age 6.8±3.1y, T1D duration 3.7±2.9y, and A1C 7.1±0.7%. Despite 1-2 missed meal bolus challenges (mean 43g, range 18-88g CHO), percent time 70-180mg/dL was 76.6±7.2% and 80.4±9.9% with targets of 110mg/dL and 120mg/dL respectively. Outcomes were similar between the targets for mean glucose and time in glycemic ranges (Table). There were no serious adverse events.
The Omnipod personalized MPC algorithm performed well and was safe in children aged 2-12y with T1D when tested at a target of 110mg/dL, even when stress-tested under challenging conditions. This algorithm is being evaluated in an at-home pivotal study with targets 110-150mg/dL.
Disclosure
J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. G.P. Forlenza: Advisory Panel; Self; Medtronic. Consultant; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. A. Galderisi: None. L. Ekhlaspour: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company, Medtronic. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk Inc., Tandem Diabetes Care. M. Zgorski: None. R.S. Kingman: None. C. Berget: None. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.
Funding
Insulet Corporation
This multi-site, retrospective study evaluated the effect of treatment with a tubeless insulin pump (Omnipod Insulin Management System, Insulet Corp., Acton, MA) on glycemic control in adults with ...type 1 diabetes (n=166) compared to prior treatment with multiple daily injections (MDI) (63%) or continuous subcutaneous insulin infusion (CSII) (37%). The primary outcome was change in A1C from baseline to 12 months post-Omnipodinitiation. Secondary outcomes included change in A1C at 3- and 6-months, and change in A1C stratified by baseline A1C and prior treatment with MDI or other CSII. Baseline characteristics were mean±SD: age 44±14 y, diabetes duration 24±14 y, 57% female, A1C 8.1±1.5%. The decrease in A1C at 12 months post-Omnipod therapy was -0.2±1.2% (8.1±1.5% vs. 7.9±1.3%; p=0.01) compared to prior treatment. A decrease in A1C was observed at 3- and 6-mo: -0.3±1.2% (n=95; p=0.005) and -0.3±1.1% (n=87; p=0.04), respectively. The within group reduction in A1C at 12 months for prior MDI use was -0.35% (8.1±1.5% vs. 7.8±1.2%; p=0.008) vs. -0.03% (8.0±1.4% vs. 8.0±1.5%; p=0.761) for CSII. The proportion of patients grouped by A1C category is shown in the Figure.
In conclusion, long-term use of the Omnipod System was associated with significant improvement in A1C in adults with type 1 diabetes, most notably in those with A1C ≥9.0% and those previously treated with MDI.
Disclosure
S.N. Mehta: None. D.F. Kruger: Advisory Panel; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Insulet Corporation. Consultant; Self; CeQur Corporation, Hygieia. Speaker's Bureau; Self; AstraZeneca, Dexcom, Inc., Eli Lilly and Company. Stock/Shareholder; Self; Dexcom, Inc. Other Relationship; Self; Novo Nordisk Inc. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. J.E. Layne: Employee; Self; Insulet Corporation. B. Dumais: None. J.R. Gallagher: None. T.T. Ly: Employee; Self; Insulet Corporation.
Funding
Insulet Corporation
Expert opinion guidelines and limited data from clinical trials recommend adjustment to bolus insulin doses based on continuous glucose monitor (CGM) trend data, yet minimal evidence exists to ...support this approach. We performed a clinical evaluation of a novel CGM-informed bolus calculator (CIBC) with automatic insulin bolus dose adjustment based on CGM trend used with sensor-augmented pump therapy.
In this multicenter, outpatient study, participants 6-70 years of age with type 1 diabetes (T1D) used the Omnipod
5 System in Manual Mode, first for 7 days without a connected CGM (standard bolus calculator, SBC, phase 1) and then for 7 days with a connected CGM using the CIBC (CIBC phase 2). The integrated bolus calculator used stored pump settings plus user-estimated meal size and/or either a manually entered capillary glucose value (SBC phase) or an imported current CGM value and trend (CIBC phase) to recommend a bolus amount. The CIBC automatically increased or decreased the suggested bolus amount based on the CGM trend.
Twenty-five participants, (mean ± standard deviation) 27 ± 15 years of age, with T1D duration 12 ± 9 years and A1C 7.0% ± 0.9% completed the study. There were significantly fewer sensor readings <70 mg/dL 4 h postbolus with the CIBC compared to the SBC (2.1% ± 2.0% vs. 2.8 ± 2.7,
= 0.03), while percent of sensor readings >180 and 70-180 mg/dL remained the same. There was no difference in insulin use or number of boluses given between the two phases.
The CIBC was safe when used with the Omnipod 5 System in Manual Mode, with fewer hypoglycemic readings in the postbolus period compared to the SBC. This trial was registered at ClinicalTrials.gov (NCT04320069).
Customization of glucose targets in hybrid closed-loop (HCL) systems is important to enable tailored glucose management and safe onboarding across a wide range of users. The safety and performance of ...the Omnipod HCL personalized model predictive control (MPC) algorithm were assessed with a lower target of 110mg/dL for the first time in those aged 12-85y with type 1 diabetes (T1D) and A1C<10.0% using an investigational device.
A 96-h HCL study was conducted in a supervised free-living hotel setting with challenges including 2 missed meal boluses, high fat dinner, and daily exercise. All participants used a 120mg/dL target for 48h, with either a day/night target of 150/110 mg/dL (n=10) or a constant 110mg/dL target (n=10) for the remaining 48h.
Participants (n=20) were (mean±SD): age 17.9±4.4y, T1D duration 9.0±5.4y, and A1C 7.6±0.9%. Despite 2 missed meal boluses (23-162g CHO), percent time from 70-180mg/dL was 76.1±14.9% and 72.9±9.2% with targets of 110 and 120mg/dL respectively (Table). Percent time <70mg/dL was low: 2.3±2.1% and 1.9±2.5% at the respective targets.
The Omnipod personalized MPC algorithm performed well and was safe in adults and adolescents with T1D when tested at a target of 110mg/dL, even when stress-tested under challenging conditions. This algorithm is being evaluated in an at-home pivotal study with targets 110-150mg/dL.
Disclosure
G.P. Forlenza: Advisory Panel; Self; Medtronic. Consultant; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company, Medtronic. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk Inc., Tandem Diabetes Care. A. Galderisi: None. L. Ekhlaspour: None. C. Berget: None. L. Hsu: Stock/Shareholder; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. M. Zgorski: None. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.
Funding
Insulet Corporation
The safety and performance of the Omnipod® hybrid closed-loop (HCL) personalized model predictive control algorithm was assessed in adolescents with type 1 diabetes (T1D) using an investigational ...device over 5 days in a supervised hotel setting under free-living conditions. Eligible participants were aged 12-17.9 y with A1C <10.0% using CSII or MDI. A 7-day open-loop (OL) phase of standard therapy (CSII/MDI) plus CGM use at home preceded the 96 h HCL phase. Meals during HCL were unrestricted, with boluses administered per usual routine. Moderate-intensity exercise was performed for ≥30 min/d. An adaptive approach was used to update participant parameters after the first 48 h of HCL. Ten participants (MDI n=3) were (mean ± SD): age 14.3 ± 1.3 y, diabetes duration 6.9 ± 3.6 y, A1C 8.2 ± 1.1% and TDD 1.01 ± 0.24 U/kg. Glycemic outcomes are reported in the table. The percentage of time 70-180 mg/dL was 18.4% higher during HCL compared to OL overall (HCL 79.0 ± 12.6 vs. OL 60.6 ± 13.4) and 23.3% higher overnight (HCL 85.4 ± 17.9 vs. OL 62.1 ± 15.7). A concomitant reduction in the percentage of time <70 mg/dL during HCL vs. OL occurred both overall (HCL 2.5 ± 2.0 vs. OL 4.4 ± 4.0) and overnight (HCL 1.3 ± 1.6 vs. OL 6.5 ± 6.6). The Omnipod HCL system was safe and performed well over 5 days of use in adolescents with T1D under free-living conditions with unrestricted meals and moderate-intensity exercise.
Glycemic outcomes during hybrid closed-loop (HCL) and open-loop (OL) phasesGlycemic outcomesHCL OverallOL OverallHCL Night (23:00 - 06:59)OL Night (23:00 - 06:59)Mean glucose (mg/dL)143.8 ± 19.6162.5 ± 25.9141.4 ± 26.5152.9 ± 31.2Percent time <54 mg/dL (%)0.4 ± 0.40.8 ± 0.80.1 ± 0.20.7 ± 1.0Percent time <70 mg/dL (%)2.5 ± 2.04.4 ± 4.01.3 ± 1.66.5 ± 6.6Percent time 70-140 mg/dL (%)54.3 ± 15.639.9 ± 14.959.6 ± 21.741.3 ± 20.1Percent time 70-180 mg/dL (%)79.0 ± 12.660.6 ± 13.485.4 ± 17.962.1 ± 15.7Percent time >180 mg/dL (%)18.5 ± 13.535.0 ± 16.213.3 ± 18.731.4 ± 20.5Percent time ≥250 mg/dL (%)3.5 ± 5.012.0 ± 6.53.3 ± 7.07.5 ± 7.2
Disclosure
G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. J. Sherr: Consultant; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Insulet Corporation, Eli Lilly and Company, Bigfoot Biomedical. T.A. Peyser: Consultant; Self; Insulet Corporation, Dexcom, Inc.. Employee; Self; ModeAGC. Consultant; Self; Biolinq. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.
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