None listed
Conditions
Brief summary
The CREATE (Community deRivEd AutomaTEd insulin delivery) trial is the first randomised controlled trial assessing an open-source algorithm for automated insulin delivery. The system studied was a version of AndroidAPS (using the OpenAPS algorithm) paired with the DANA-i™ insulin pump and Dexcom G6® CGM. The user interface was an Android smartphone application: termed AnyDANA-Loop for convenience in the study. Participants used the AnyDANA-Loop application for mealtime insulin dosing and AnyDANA-Loop then automated insulin delivery in response to the glucose target. The study included 100 participants 7-70 years from four diabetes centres in New Zealand. The 6 month RCT assessed efficacy and safety of open-source AID compared to sensor augmented pump therapy (SAPT). A 6 month continuation phase followed to assess long-term efficacy and safety, with the majority of participants undergoing a hardware switch to use an YpsoPump in place of the Dana pump.
Interventions
Participants in the intervention arm used AnyDANA-Loop during the 6month RCT. AnyDANA-Loop is an AID system consisting of an the Dana-iTM insulin pump, Dexcom G6® CGM, and a locked-down version of the AndroidAPS algorithm (as an application installed on a smartphone provided to all participants). The AnyDANA-Loop app communicates with the Dana-iTM pump to obtain details of all recent insulin dosing (basal and boluses) and with the CGM to obtain current and recent sensor glucose levels, and issue
Participants in the intervention arm used AnyDANA-Loop during the 6month RCT. AnyDANA-Loop is an AID system consisting of an the Dana-iTM insulin pump, Dexcom G6® CGM, and a locked-down version of the AndroidAPS algorithm (as an application installed on a smartphone provided to all participants). The AnyDANA-Loop app communicates with the Dana-iTM pump to obtain details of all recent insulin dosing (basal and boluses) and with the CGM to obtain current and recent sensor glucose levels, and issues commands to the pump to adjust insulin dosing to optimise glucose levels. Approximately three months into the study with around two thirds of the cohort having had been recruited, a universal issue with the Dana-iTM insulin pump battery draining quickly (within hours to days) emerged. As a result, the Dana-iTM pumps underwent a rigorous process of refurbishment, and further recruitment was delayed until refurbished pumps had been deployed to active participants. AID users were able to be supported to safely continue AID with the Dana-iTM pump and they were given priority for a refurbished pump. During the 6month continuation phase, participants in the intervention arm had the option to continue using the Dana-i insulin pump with automation, or switch to the YpsoPump with automation. The insulin pump was the only a change, and the AID algorithm was unchanged.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Type 1 diabetes as per the American Diabetes Association classification for > 1 years prior to the Baseline Visit 2. Aged 7 - 70 years inclusive stratified into two groups (7 - 15 years inclusive and 16 - 70 years years inclusive) at Baseline 3. Currently on insulin pump therapy for > 6 months prior to the Baseline Visit 4. Mean HbA1c < 10.5% (91 mmol/mol) within 6 months prior to the Baseline Visit (minimum of one test) 5. Willing and able to adhere to the study protocol 6. Have daily access to a Wi-Fi network
Exclusion criteria
Exclusion criteria: 1. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary 2. Alcohol or drug dependence 3. Severe visual impairment that would impair use of the device 4. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study 5. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study 6. Allergic or intolerant to NovoRapid® insulin
Outcome results
None listed