TY - JOUR
T1 - Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes
T2 - the ‘CLOSE IT’ (Closed Loop Open SourcE In Type 1 diabetes) trial
AU - Wilkinson, Tom
AU - Tomic, Dunya
AU - Boyle, Erin
AU - Burren, David
AU - Elghattis, Yasser
AU - Jenkins, Alicia
AU - Keesing, Celeste
AU - Middleton, Sonia
AU - Nanayakkara, Natalie
AU - Williman, Jonathan
AU - de Bock, Martin
AU - Cohen, Neale D.
N1 - Funding Information:
The trial is being funded by a grant from the JDRF non-profit diabetes research fund (grant key 2-SRA-2023-1266-M-B). No pharmaceutical or technology companies were involved in the design and development of this trial, nor in the writing and editing of this manuscript.
Funding Information:
TW, DT, EB, YE and NN have nothing to disclose. MdB declares receiving speaker fees from Medtronic, Dexcom, Boerhinger Ingelheim, research support from Dexcom, Medtronic, Novonordisk, Pfizer, SOOIL, and has served as advisory board membership for Dexcom. NDC declares speaker fees from Novo Nordisk, Lilly, Boehringer Ingelheim, Abbott and research support from Ypsomed, Novo Nordisk, Boehringer Ingelheim, Astra Zeneca, Novartis. JW declares research support from Dexcom and SOOIL. DB declares employment at Nascence Biomed (which provides the technical platform for the CLOSE IT trial) and serving on an editorial board for Ascensia.
Publisher Copyright:
© 2024 BMJ Publishing Group. All rights reserved.
PY - 2024/2/20
Y1 - 2024/2/20
N2 - Introduction Multiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined by user-associated burdens, including the need to carbohydrate count and deliver manual insulin boluses. There is an important need for a ‘fully automated closed loop’ (FCL) AID system, without manual mealtime boluses. The (Closed Loop Open SourcE In Type 1 diabetes) trial is a randomised trial comparing an FCL AID system to the same system used as a hybrid closed loop (HCL) in people with T1D, in an outpatient setting over an extended time frame. Methods and analysis Randomised, open-label, parallel, non-inferiority trial comparing the Android Artificial Pancreas System (AAPS) AID algorithm used as FCL to the same algorithm used as HCL. Seventy-five participants aged 18–70 will be randomised (1:1) to one of two treatment arms for 12 weeks: (a) FCL—participants will be advised not to bolus for meals and (b) HCL—participants will use the AAPS AID algorithm as HCL with announced meals. The primary outcome is the percentage of time in target sensor glucose range (3.9–10.0 mmol/L). Secondary outcomes include other glycaemic metrics, safety, psychosocial factors, platform performance and user dietary factors. Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide). Ethics and dissemination Approvals are by the Alfred Health Ethics Committee (615/22) (Australia) and Health and Disability Ethics Committees (2022 FULL 13832) (New Zealand). Each participant will provide written informed consent. Data protection and confidentiality will be ensured. Study results will be disseminated by publications, conferences and patient advocacy groups. Trial registration numbers ACTRN12622001400752 and ACTRN12622001401741.
AB - Introduction Multiple automated insulin delivery (AID) systems have become commercially available following randomised controlled trials demonstrating benefits in people with type 1 diabetes (T1D). However, their real-world utility may be undermined by user-associated burdens, including the need to carbohydrate count and deliver manual insulin boluses. There is an important need for a ‘fully automated closed loop’ (FCL) AID system, without manual mealtime boluses. The (Closed Loop Open SourcE In Type 1 diabetes) trial is a randomised trial comparing an FCL AID system to the same system used as a hybrid closed loop (HCL) in people with T1D, in an outpatient setting over an extended time frame. Methods and analysis Randomised, open-label, parallel, non-inferiority trial comparing the Android Artificial Pancreas System (AAPS) AID algorithm used as FCL to the same algorithm used as HCL. Seventy-five participants aged 18–70 will be randomised (1:1) to one of two treatment arms for 12 weeks: (a) FCL—participants will be advised not to bolus for meals and (b) HCL—participants will use the AAPS AID algorithm as HCL with announced meals. The primary outcome is the percentage of time in target sensor glucose range (3.9–10.0 mmol/L). Secondary outcomes include other glycaemic metrics, safety, psychosocial factors, platform performance and user dietary factors. Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide). Ethics and dissemination Approvals are by the Alfred Health Ethics Committee (615/22) (Australia) and Health and Disability Ethics Committees (2022 FULL 13832) (New Zealand). Each participant will provide written informed consent. Data protection and confidentiality will be ensured. Study results will be disseminated by publications, conferences and patient advocacy groups. Trial registration numbers ACTRN12622001400752 and ACTRN12622001401741.
UR - http://www.scopus.com/inward/record.url?scp=85185772915&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-078171
DO - 10.1136/bmjopen-2023-078171
M3 - Article
C2 - 38382954
AN - SCOPUS:85185772915
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e078171
ER -