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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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Secher, Anna Lilja ; Pedersen-Bjergaard, Ulrik ; Svendsen, Ole L ; Gade-Rasmussen, Birthe ; Almdal, Thomas ; Raimond, Linda ; Vistisen, Dorte ; Nørgaard, Kirsten. / Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections : a 26 week randomised, controlled, multicentre trial. I: Diabetologia. 2021 ; Bind 64, Nr. 12. s. 2713-2724.

Bibtex

@article{9f1c296ec1ca4e98b44614109a423ed1,
title = "Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections: a 26 week randomised, controlled, multicentre trial",
abstract = "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.",
keywords = "Automated bolus calculation, Continuous glucose monitoring, Flash glucose monitoring, Glycaemic control, HbA, Multiple daily insulin injections, Time in range, Type 1 diabetes",
author = "Secher, {Anna Lilja} and Ulrik Pedersen-Bjergaard and Svendsen, {Ole L} and Birthe Gade-Rasmussen and Thomas Almdal and Linda Raimond and Dorte Vistisen and Kirsten N{\o}rgaard",
note = "{\textcopyright} 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.",
year = "2021",
month = dec,
doi = "10.1007/s00125-021-05555-8",
language = "English",
volume = "64",
pages = "2713--2724",
journal = "Diabetologia",
issn = "0012-186X",
publisher = "Springer",
number = "12",

}

RIS

TY - JOUR

T1 - Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections

T2 - a 26 week randomised, controlled, multicentre trial

AU - Secher, Anna Lilja

AU - Pedersen-Bjergaard, Ulrik

AU - Svendsen, Ole L

AU - Gade-Rasmussen, Birthe

AU - Almdal, Thomas

AU - Raimond, Linda

AU - Vistisen, Dorte

AU - Nørgaard, Kirsten

N1 - © 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - Automated bolus calculation

KW - Continuous glucose monitoring

KW - Flash glucose monitoring

KW - Glycaemic control

KW - HbA

KW - Multiple daily insulin injections

KW - Time in range

KW - Type 1 diabetes

UR - http://www.scopus.com/inward/record.url?scp=85114407425&partnerID=8YFLogxK

U2 - 10.1007/s00125-021-05555-8

DO - 10.1007/s00125-021-05555-8

M3 - Journal article

C2 - 34495375

VL - 64

SP - 2713

EP - 2724

JO - Diabetologia

JF - Diabetologia

SN - 0012-186X

IS - 12

ER -

ID: 67561789