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Observational Study
. 2023 Oct 1;46(10):1831-1838.
doi: 10.2337/dc23-0635.

Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study

Thomas S J Crabtree  1   2 , Tomás P Griffin  3   4 , Yew W Yap  5 , Parth Narendran  6   7 , Geraldine Gallen  8 , Niall Furlong  9 , Iain Cranston  10 , Ali Chakera  11   12 , Chris Philbey  13 , Muhammad Ali Karamat  14 , Sanjay Saraf  15 , Shafie Kamaruddin  16 , Eleanor Gurnell  17 , Alyson Chapman  18 , Sufyan Hussain  19   20 , Jackie Elliott  21 , Lalantha Leelarathna  18 , Robert E J Ryder  22 , Peter Hammond  13 , Alistair Lumb  23   24 , Pratik Choudhary  3   4 , Emma G Wilmot  1   2 ; ABCD Closed-Loop Audit Contributors
Collaborators, Affiliations
Observational Study

Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study

Thomas S J Crabtree et al. Diabetes Care. .

Abstract

Objective: We explored longitudinal changes associated with switching to hybrid closed-loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy.

Research design and methods: We undertook a pragmatic, preplanned observational study of participants included in the National Health Service England closed-loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with an HbA1c ≥8.5% who were willing to commence HCL therapy were included. Outcomes included change in HbA1c, sensor glucometrics, diabetes distress score, Gold score (hypoglycemia awareness), acute event rates, and user opinion of HCL.

Results: In total, 570 HCL users were included (median age 40 [IQR 29-50] years, 67% female, and 85% White). Mean baseline HbA1c was 9.4 ± 0.9% (78.9 ± 9.1 mmol/mol) with a median follow-up of 5.1 (IQR 3.9-6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8; P < 0.0001) (18.1 mmol/mol [95% CI 16.6, 19.6]; P < 0.0001). Time in range (70-180 mg/dL) increased from 34.2 to 61.9% (P < 0.001). Individuals with HbA1c of ≤58 mmol/mol rose from 0 to 39.4% (P < 0.0001), and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8 to 28.2% (P < 0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7% [540 of 570]).

Conclusions: Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia, and diabetes-related distress and quality of life in people with type 1 diabetes in the real world.

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Conflict of interest statement

Duality of Interest. T.S.J.C. has received personal fees from Novo Nordisk, Sanofi, Insulet, Eli Lilly, Dexcom, and Abbott Diabetes Care. T.P.G. has received personal fees from Novo Nordisk, Dexcom, Sanofi Aventis, Mundipharma, AbbVie, and Eli Lilly. P.N. has received speaker and advisory board fees from Lilly Diabetes Care, Abbott Diabetes Care, and Sanofi. G.G. has received advisory and speaker fees from Abbott, Medtronic, Insulet, and Dexcom. N.F. has received speaker fees from Novo Nordisk and Sanofi. I.C. has received speaker and advisory fees from Abbott Diabetes Care, Eli Lilly, Novo Nordisk, Insulet, and Dexcom. C.P. has received speaker fees and support to attend conferences from Novo Nordisk. M.A.K. has received speaker and/or advisory board fees from Novo Nordisk, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Sanofi, and Abbott Diabetes Care. S.K. has received speaker fees from Novo Nordisk, Sanofi Aventis, Eli Lilly, and Medtronic. J.E. has received speaker and advisory board fees from Abbott, Dexcom, Insulet, Eli Lilly, Novo Nordisk, Roche, and Sanofi. R.E.J.R. has received speaker fees, consultancy fees, and/or educational sponsorships from BioQuest, GI Dynamics, and Novo Nordisk. P.H. has received personal fees from Abbott Diabetes Care, Eli Lilly, Insulet, Medtronic, and Sanofi Aventis. A.L. has received personal fees from Insulet, Dexcom, Abbott Diabetes Care, Novo Nordisk, Sanofi, and Eli Lilly and institutional research support from Novo Nordisk and Abbott Diabetes Care. P.C. has received personal fees from Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, Sanofi Aventis, and Glooko. E.G.W. has received personal fees from Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly, Embecta, Glooko, Insulet, Medtronic, Novo Nordisk, Roche, Sanofi Aventis, and Ypsomed. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
A: Violin plot demonstrating HbA1c at baseline and follow-up (P < 0.0001). B: Scatter plot showing individual patient data for HbA1c at baseline, with the line representing the threshold for no change in HbA1c. C: Stacked bar chart demonstrating TIR at baseline and follow-up. Data are for individuals with complete sensor data only (n = 380).
Figure 2
Figure 2
Proportion of individuals achieving targets for HbA1c, GMI, TIR, and a composite outcome of TIR and TBR at baseline and follow-up.
See this image and copyright information in PMC

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