None listed
Conditions
Brief summary
Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with T1D. AID combines an insulin pump and continuous glucose monitor (a small sensor worn under the skin) with a maths program, which tells the pump how much insulin to give based on the glucose levels. Current AID systems still require users to manually give insulin at mealtimes. In this trial we will investigate an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. We will recruit 75 people with diabetes across Australia and New Zealand to one of two study sites: the Baker Institute in Melbourne and the University of Otago in Christchurch. The duration of the study is six months. During the first three months everyone will start on an insulin pump and continuous glucose monitor. Participants will need to manually give a bolus whenever they have a meal, but the system will automate all other aspects of insulin deliver. We'll gradually adjust the settings to achieve the best possible control. During the second three months participants will be randomly divided into two groups. The first group will stop giving manual insulin boluses with meals. The second group will continue to give manual insulin boluses with meals. At the end of the trial we'll compare the glucose recording between the two groups, to see if stopping manual boluses made any difference to diabetes control. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge. We'll also collect data relating to the experiences of participants using the AID system, including standardised questionnaires and an interview with 15 participants.
Interventions
This randomised controlled trial will assess the safety and efficacy of the Android Artificial Pancreas System (AAPS) when used without manual mealtime boluses.
AAPS is an automated insulin delivery system, which in this trial will comprise an Ypsomed insulin pump, Dexcom G6 continous glucose monitor (CGM), and an Android phone containing an open-source algorithm. The algorithm uses glucose recordings to calculate required insulin doses and instructs the insulin pump to deliver those doses, in
This randomised controlled trial will assess the safety and efficacy of the Android Artificial Pancreas System (AAPS) when used without manual mealtime boluses. AAPS is an automated insulin delivery system, which in this trial will comprise an Ypsomed insulin pump, Dexcom G6 continous glucose monitor (CGM), and an Android phone containing an open-source algorithm. The algorithm uses glucose recordings to calculate required insulin doses and instructs the insulin pump to deliver those doses, in an automated manner. All participants will be established on AAPS during a three month run-in phase (days 1-84). This will be as a "hybrid" system, whereby participants are still required to give manual insulin boluses around mealtimes, based on carbohydrate counting. This is in keeping with currently established use of the system. Carbohydrate counting will be carried out by the participant, and manual insulin boluses will be delivered using the Ypsomed insulin pump. The study team will advise each individual participant of ratios to be used when calculating insulin boluses (insulin sensitivity factor, carbohydrate ratio). These ratios will likely differ significantly between individuals, resulting in significant variability in bolus size between individuals. The Ypsopump is capable of delivering up to 30 units of insulin in a single bolus. At the start of the run-in phase participants will attend a face-to-face visit with a member of the study team, at which time they will be provided with the insulin pump and CGM system, and receive training on use of the pump and carbohydrate counting. Insulin pump therapy will only commence once the study team is satisfied that the participant has received adequate training to use the pump safely. Some participants may require multiple site visits before starting pump therapy. Participants will either directly commence the AAPS algorithm or will first use manual pump therapy - this decision will be made by the study team on an individual basis, in consultation with the participant. Once AAPS has started, participants will gradually adjust settings in consultation with the study team, and enable advanced features including supermicroboluses. Supermicroboluses are automated correction boluses delivered by the algorithm in conjunction with numerous safety checks, including temporary suspension of basal insulin delivery. To guide this process, the study team will perform weekly electronic remote review for each participant during the run-in phase, accessing CGM recordings and pump records of insulin delivery, both of which will be uploaded to secure cloud-based systems. The intention is that, by the end of the run-in phase, all participants will be established on AAPS with supermicroboluses enabled and settings optimised. Participants will then proceed to a three month trial phase (days 85-168), in which they will be randomised on a 1:1 basis to the intervention group or the control group. In the intervention group participants will be asked to stop delivering manual mealtime insulin boluses. They will be instructed to only give a manual bolus if blood glucose is >15.0 mmol/L for >1 hour, or if they feel unwell due to hyperglycaemia. Pump insulin delivery and CGM recordings will be uploaded to a secure cloud-based system. These data will be accessed by the study team and, in conjunction with contact with participants where required, will be used to verify participant adherence to the intervention. At the end of the trial participants will return the study devices, including the Ypsopump and will be supported to resume their usual diabetes therapy prior to discharge from the study. The advanced AAPS algorithm does not currently have regulatory approval, limiting the potential feasibility of ongoing use after trial completion, however participants will be supported if they wish to continue using the algorithm. This would be dependent for each participant on the availability of CGM and an insulin pump compatible with the algorithm.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes as per the American Diabetes Association classification for > 12 months prior to the screening visit 2. Aged 18 – 70 years inclusive 3. Willing and able to adhere to the study protocol
Exclusion criteria
1. If female, is pregnant or plans to become pregnant while participating in the study. A positive pregnancy test at screening is exclusionary. 2. Use of non-insulin glucose lowering therapy within 3 months of study commencement. 3. Severe renal impairment (eGFR < 30 mL/min/1.73m2). 4. Any documented active or suspected malignancy, except appropriately treated basal cell or squamous cell carcinoma of the skin or any “in situ” carcinoma. 5. Acute cardiovascular event (myocardial infarction, unstable angina, stroke) in the 3 months prior to study commencement. 6. Severe hypoglycaemia or diabetic ketoacidosis in the 3 months prior to study commencement. 7. Consumption of a very low carbohydrate diet, defined as carbohydrate intake <40g per day. 8. Inability to use insulin pump and mobile phone. 9. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study. 10. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study. 11. Allergy to insulin NovoRapid®
Outcome results
None listed