TY - JOUR
T1 - Bihormonal fully closed-loop system for the treatment of type 1 diabetes
T2 - a real-world multicentre, prospective, single-arm trial in the Netherlands
AU - van Bon, A.C.
AU - Blauw, H.
AU - Jansen, T.J.P.
AU - Laverman, G.D.
AU - Urgert, T.
AU - Geessink-Mennink, J.
AU - Mulder, A.H.
AU - Out, M.
AU - Groote Veldman, R.
AU - Onvlee, A.J.
AU - Schouwenberg, B.J.J.W.
AU - Vermeulen, M.A.R.
AU - Diekman, M.J.M.
AU - Gerding, M.N.
AU - van Wijk, J.P.H.
AU - Klaassen, M.
AU - Witkop, M.
AU - DeVries, J.H.
N1 - Publisher Copyright:
© 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2024/4
Y1 - 2024/4
N2 - Background: Management of insulin administration for intake of carbohydrates and physical activity can be burdensome for people with type 1 diabetes on hybrid closed-loop systems. Bihormonal fully closed-loop (FCL) systems could help reduce this burden. In this trial, we assessed the long-term performance and safety of a bihormonal FCL system.Methods: The FCL system (Inreda AP; Inreda Diabetic, Goor, Netherlands) that uses two hormones (insulin and glucagon) was assessed in a 1 year, multicentre, prospective, single-arm intervention trial in adults with type 1 diabetes. Participants were recruited in eight outpatient clinics in the Netherlands. We included adults with type 1 diabetes aged 18–75 years who had been using flash glucose monitoring or continuous glucose monitors for at least 3 months. Study visits were integrated into standard care, usually every three months, to evaluate glycaemic control, adverse events, and person-reported outcomes. The primary endpoint was time in range (TIR; glucose concentration 3·9–10·0 mmol/L) after 1 year. The study is registered in the Dutch Trial Register, NL9578.Findings: Between June 1, 2021, and March 2, 2022, we screened 90 individuals and enrolled 82 participants; 78 were included in the analyses. 79 started the intervention and 71 were included in the 12 month analysis. Mean age was 47.7 (SD 12·4) years and 38 (49%) were female participants. The mean preintervention TIR of participants was 55·5% (SD 17·2). After 1 year of FCL treatment, mean TIR was 80·3% (SD 5·4) and median time below range was 1·36% (IQR 0·80–2·11). Questionnaire scores improved on Problem Areas in Diabetes (PAID) from 30·0 (IQR 18·8–41·3) preintervention to 10·0 (IQR 3·8–21·3; p<0·0001) at 12 months and on World Health Organization-Five Well-Being Index (WHO-5) from 60·0 (IQR 44·0–72·0) preintervention to 76·0 (IQR 60·0–80·0; p<0·0001) at 12 months. Five serious adverse events were reported (one cerebellar stroke, two severe hypoglycaemic, and two hyperglycaemic events).Interpretation: Real-world data obtained in this trial demonstrate that use of the bihormonal FCL system was associated with good glycaemic control in patients who completed 1 year of treatment, and could help relieve these individuals with type 1 diabetes from making treatment decisions and the burden of carbohydrate counting.
AB - Background: Management of insulin administration for intake of carbohydrates and physical activity can be burdensome for people with type 1 diabetes on hybrid closed-loop systems. Bihormonal fully closed-loop (FCL) systems could help reduce this burden. In this trial, we assessed the long-term performance and safety of a bihormonal FCL system.Methods: The FCL system (Inreda AP; Inreda Diabetic, Goor, Netherlands) that uses two hormones (insulin and glucagon) was assessed in a 1 year, multicentre, prospective, single-arm intervention trial in adults with type 1 diabetes. Participants were recruited in eight outpatient clinics in the Netherlands. We included adults with type 1 diabetes aged 18–75 years who had been using flash glucose monitoring or continuous glucose monitors for at least 3 months. Study visits were integrated into standard care, usually every three months, to evaluate glycaemic control, adverse events, and person-reported outcomes. The primary endpoint was time in range (TIR; glucose concentration 3·9–10·0 mmol/L) after 1 year. The study is registered in the Dutch Trial Register, NL9578.Findings: Between June 1, 2021, and March 2, 2022, we screened 90 individuals and enrolled 82 participants; 78 were included in the analyses. 79 started the intervention and 71 were included in the 12 month analysis. Mean age was 47.7 (SD 12·4) years and 38 (49%) were female participants. The mean preintervention TIR of participants was 55·5% (SD 17·2). After 1 year of FCL treatment, mean TIR was 80·3% (SD 5·4) and median time below range was 1·36% (IQR 0·80–2·11). Questionnaire scores improved on Problem Areas in Diabetes (PAID) from 30·0 (IQR 18·8–41·3) preintervention to 10·0 (IQR 3·8–21·3; p<0·0001) at 12 months and on World Health Organization-Five Well-Being Index (WHO-5) from 60·0 (IQR 44·0–72·0) preintervention to 76·0 (IQR 60·0–80·0; p<0·0001) at 12 months. Five serious adverse events were reported (one cerebellar stroke, two severe hypoglycaemic, and two hyperglycaemic events).Interpretation: Real-world data obtained in this trial demonstrate that use of the bihormonal FCL system was associated with good glycaemic control in patients who completed 1 year of treatment, and could help relieve these individuals with type 1 diabetes from making treatment decisions and the burden of carbohydrate counting.
UR - http://www.scopus.com/inward/record.url?scp=85186725489&partnerID=8YFLogxK
U2 - 10.1016/S2589-7500(24)00002-5
DO - 10.1016/S2589-7500(24)00002-5
M3 - Article
C2 - 38443309
AN - SCOPUS:85186725489
SN - 2589-7500
VL - 6
SP - e272-e280
JO - The Lancet Digital Health
JF - The Lancet Digital Health
IS - 4
ER -
