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Randomized Controlled Trial
. 2024 Dec 1;47(12):2248-2257.
doi: 10.2337/dc24-1550.

Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial

Eric Renard  1 , Ruth S Weinstock  2 , Grazia Aleppo  3 , Bruce W Bode  4 , Sue A Brown  5 , Kristin Castorino  6 , Irl B Hirsch  7 , Mark S Kipnes  8 , Lori M Laffel  9 , Rayhan A Lal  10 , Alfred Penfornis  11 , Jean-Pierre Riveline  12 , Viral N Shah  13 , Charles Thivolet  14 , Trang T Ly  15 ; OP5-003 Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial

Eric Renard et al. Diabetes Care. .

Abstract

Objective: To examine the efficacy and safety of the tubeless Omnipod 5 automated insulin delivery (AID) system compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes.

Research design and methods: In this 13-week multicenter, parallel-group, randomized controlled trial performed in the U.S. and France, adults aged 18-70 years with type 1 diabetes and HbA1c 7-11% (53-97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70-180 mg/dL) during the trial period.

Results: A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P < 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD -1.24 ± 0.75% [-13.6 ± 8.2 mmol/mol] vs. -0.68 ± 0.93% [-7.4 ± 10.2 mmol/mol], respectively; P < 0.0001), accompanied by a significantly lower time <70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and >180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P < 0.0001). All primary and secondary outcomes were met. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group.

Conclusions: Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population.

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Conflict of interest statement

Duality of Interest. E.R. declares consultant/speaker fees from A. Menarini Diagnostics, Abbott, Air Liquide SI, AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim, Cellnovo, Dexcom, Eli Lilly, Hillo, Insulet Corporation, Johnson & Johnson (Animas, LifeScan), Medtronic, Medirio, Novo Nordisk, Roche, and Sanofi Aventis and research support from Abbott, Dexcom Inc., Insulet Corporation, Roche, and Tandem Diabetes Care. R.S.W. participated in clinical trials, through her institution, sponsored by Amgen, Diasome, Insulet Corporation, Eli Lilly, MannKind, and Tandem and has used Dexcom devices obtained at a reduced cost for clinical studies. G.A. reports consultant fees from Dexcom, Insulet Corporation, and Medscape and has received research support through her institution from Fractyl Health, Insulet Corporation, MannKind, Tandem Diabetes, and Welldoc. B.W.B. reports research support from Insulet Corporation during the conduct of the study; research support from Abbott, Advance, Diasome, Dexcom, Janssen, Eli Lilly, Medtronic, Novo Nordisk, Provention Bio, Sanofi, Sanvita, Senseonics, REMD Biotherapeutics, Xeris, and vTv Therapeutics; and consultant and speaking fees from Boehringer Ingelheim, Insulet Corporation, Eli Lilly, MannKind, Medtronic, Novo Nordisk, Sanofi, Senseonics, Sanofi, Xeris, and Zealand. S.A.B. receives research support to her institution from Dexcom, Insulet Corporation, and Tandem Diabetes Care and participation on a data monitoring board (without fees) for MannKind. K.C. receives research support provided to her institution from Dexcom, Abbott, Medtronic, Eli Lilly, MannKind, and Insulet Corporation and consulting and/or advisory fees from Dexcom, MannKind, and Laxmi. I.B.H. reports research support from Dexcom, Insulet Corporation, Tandem, and MannKind and consulting fees from Abbott, Roche, Hagar, Vertex Pharmaceuticals, and Embecta. M.S.K. reports research support from 89bio, Diamyd Medical, Abbott, Akero Therapeutics, Kowa Pharmaceuticals, Zydus Pharmaceuticals, Biolinq, Corcept Therapeutics, Dexcom, Eli Lilly, Gilead, Insulet Corporation, Ionis, MannKind, Novo Nordisk, Pfizer, Reata Pharmaceuticals, Inventiva Pharma, and Tandem; clinical events committee fees from Tandem; and advisory board fees from Quest Diagnostics and Corcept Therapeutics. L.M.L. has received consulting fees from Provention Bio, Sanofi, Medtronic, MannKind, Janssen, Eli Lilly, Dexcom, Novo Nordisk, and Vertex. R.A.L. has received consulting fees from Abbott Diabetes Care, Adaptyx Biosciences, Biolinq, Capillary Biomedical, Deep Valley Labs, Gluroo, PhysioLogic Devices, and Tidepool; has served on advisory boards for Provention Bio and Eli Lilly; and receives research support from his institution from Insulet Corporation, Medtronic, and Tandem. A.P. reports personal fees from Abbott Diabetes Care, Dexcom, Diabeloop, Insulet Corporation, Eli Lilly, Novo Nordisk, Medtronic, and Sanofi and is an advisory board member for Insulet Corporation and Medtronic. J.-P.R. is an advisory panel member for Sanofi Aventis MSD, Eli Lilly, Novo Nordisk, AstraZeneca, Abbott, Dexcom, Alphadiab, Air Liquide, and Medtronic and has received research funding from Abbott, Air Liquide, Sanofi, Eli Lilly, Insulet Corporation, and Novo Nordisk. V.N.S. reports receiving fees from Dexcom, Insulet Corporation, Embecta, Ascensia Diabetes Care, Tandem Diabetes, Sanofi, Novo Nordisk, Gemonlink, and LumosFit for consulting, advising, or speaking. C.T. reports personal fees from Abbott Diabetes Care, Glooko, Eli Lilly, Novo Nordisk, Medtronic, and Sanofi and is an advisory board member for Insulet Corporation and Medtronic. T.T.L. is a full-time employee of and owns stock in Insulet Corporation. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Glycemic outcomes during standard therapy and over the 13-week trial period for each treatment group. A: Box plot of the percentage of TIR (70–180 mg/dL) during standard therapy and over the 13-week trial period for each treatment group. B: Cumulative distribution plot of the cumulative percentage of participants compared with the percentage of TIR over the 13-week trial period for each treatment group. C: Envelope plot of the sensor glucose level over the 13-week trial period according to time of day. Lines denote the median values of the participants’ glucose levels, and shaded regions indicate the interquartile range. D: Box plot of the percentage of time below range (<70 mg/dL) during standard therapy and over the 13-week trial period for each treatment group. To convert values for glucose to mmol/L, multiply by 0.05551.
See this image and copyright information in PMC

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