Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections: a 26 week randomised, controlled, multicentre trial

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Aims/hypothesis: We aimed to compare the effects of intermittently scanned continuous glucose monitoring (isCGM) and carbohydrate counting with automated bolus calculation (ABC) with usual care. Methods: In a randomised, controlled, open-label trial carried out at five diabetes clinics in the Capital Region of Denmark, 170 adults with type 1 diabetes for ≥1 year, multiple daily insulin injections and HbA1c > 53 mmol/mol (7.0%) were randomly assigned 1:1:1:1 with centrally prepared envelopes to usual care (n = 42), ABC (n = 41), isCGM (n = 48) or ABC+isCGM (n = 39). Blinded continuous glucose monitoring data, HbA1c and patient-reported outcomes were recorded at baseline and after 26 weeks. The primary outcome was change in time in range using isCGM vs usual care. Results: Baseline characteristics were comparable across arms: mean age 47 (SD 13.7) years, median (IQR) diabetes duration 18 (10–28) years and HbA1c 65 (61–72) mmol/mol (8.1% [7.7–8.7%]). Change in time in range using isCGM was comparable to usual care (% difference of 3.9 [−12–23], p = 0.660). The same was true for the ABC and ABC+isCGM arms and for hypo- and hyperglycaemia. Also compared with usual care, using ABC+isCGM reduced HbA1c (4 [95% CI 1, 8] mmol/mol) (0.4 [0.1, 0.7] %-point) and glucose CV (11% [4%, 17%]) and improved treatment satisfaction, psychosocial self-efficacy and present life quality. Treatment satisfaction also improved by using isCGM alone vs usual care. Statistical significance was maintained after multiple testing adjustment concerning glucose CV and treatment satisfaction with ABC+isCGM, and treatment satisfaction with isCGM. Discontinuation was most common among ABC only users, and among completers the ABC was used 4 (2–5) times/day and the number of daily isCGM scans was 5 (1–7) at study end. Conclusions/interpretation: isCGM alone did not improve time in range, but treatment satisfaction increased in technology-naive people with type 1 diabetes and suboptimal HbA1c. The combination of ABC+isCGM appears advantageous regarding glycaemic variables and patient-reported outcomes, but many showed resistance towards ABC. Trial registration: ClinicalTrials.gov NCT03682237. Funding: The study is investigator initiated and financed by the Capital Region of Denmark. Graphical abstract: [Figure not available: see fulltext.]

OriginalsprogEngelsk
TidsskriftDiabetologia
Vol/bind64
Udgave nummer12
Sider (fra-til)2713-2724
Antal sider12
ISSN0012-186X
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
We are deeply thankful for the participants? willingness to spend the time needed on data contribution. We also thank all study nurses and dietitians, especially A. G. Skouboe, M. M. Andersen, H. H. N?rgaard, A. Frederiksen and A. E. K. Linddal; the referring clinicians; and M. A. Campbell and K. Panduro for their help on the data collection procedure. ALS, OLS, BG-R and LHR declare that there are no relationships or activities that might bias, or be perceived to bias, their work. UP-B has received research grants from Novo Nordisk and personal fees as adviser or consultant from Abbott, Novo Nordisk, Sanofi and Zealand Pharma, and is a member of the Editorial Board of Diabetologia. DV holds stocks in Novo Nordisk. TA holds stocks in Novo Nordisk. KN serves as an adviser to Medtronic, Abbott and Novo Nordisk; owns shares in Novo Nordisk; has received research grants from Novo Nordisk, Zealand Pharma, Medtronic and Roche; and has received fees for speaking from Medtronic, Roche, Zealand Pharma, Novo Nordisk and Dexcom.

Funding Information:
The study is investigator initiated and financed by the Capital Region of Denmark. This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. None of the investigators have personal financial interest in the conduct or the outcome of the project.

Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

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