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. We are investigating an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. A key barrier that may prevent AID systems from maintaining good glucose control around meal times is speed. This is because it takes several minutes for the glucose sensor to detect a rise in blood glucose, and then several minutes for the insulin to act once it is delivered. We are investigating an ultra-fast acting preparation of insulin, called Fiasp, to see if this is more effective than a "standard" insulin (NovoRapid) in managing mealtime glucose levels. We will recruit 20 participants into this trial. They will have already completed a six-month trial (CLOSE IT), in which they will have used an automated insulin delivery system without mealtime boluses, using insulin NovoRapid. We will change NovoRapid to Fiasp and look to see if this has any effect on glucose levels over the course of four weeks. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge.
Interventions
This extension of the CLOSE IT trial will investigate the efficacy and safety of an ultra-fast acting insulin (Fiasp), when used in a fully-automated insulin delivery system.
AAPS (Android Artificial Pancreas System) is an automated insulin delivery system, which in this trial will comprise an Ypsomed insulin pump, Dexcom G6 continous glucose monitor, and an Android phone containing an open-source algorithm. The algorithm uses glucose recordings to calculate required insulin doses and instructs
This extension of the CLOSE IT trial will investigate the efficacy and safety of an ultra-fast acting insulin (Fiasp), when used in a fully-automated insulin delivery system. AAPS (Android Artificial Pancreas System) is an automated insulin delivery system, which in this trial will comprise an Ypsomed insulin pump, Dexcom G6 continous glucose monitor, 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. Participants in this extension trial will be recruited from the intervention arm of CLOSE IT. At the time of recruitment they will have used AAPS for six months, including three months with no manual mealtime boluses. Participants will continue this system, however the insulin delivered will change from fast acting NovoRapid (aspart) to ultra-fast acting Fiasp (aspart with niacinamide). Participants will attend a face-to-face study visit, where they will be supplied with Fiasp and receive instruction on its use. The extension study will last 4 weeks, with participants using Fiasp throughout this time, delivered subcutaneously by insulin pump. The specific dose delivered will be that selected by AAPS and likely to significantly vary between participants. We anticipate a typical total daily insulin dose in the range of 0.3-0.5 units per kg body weight. 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 ongoing participant adherence to instructed use of the AAPS system, including specifically not to give manual insulin boluses at mealtimes unless glucose is > 15.0 mmol/L for > 1 hour or symptoms of hyperglycaemia develop. 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. If participants in Australia wish to continue using Fiasp this will be communicated to their usual clinical team. As Fiasp is an unapproved medication in New Zealand, participants in New Zealand will not be able to continue using Fiasp after the trial has concluded.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants will be drawn from those randomised to the intervention arm of the main CLOSE IT trial. Inclusion criteria for CLOSE IT are: 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