None listed
Conditions
Brief summary
Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is an emerging therapy that improves outcomes for people with diabetes. This study investigates a "next-generation" AID system. The study will include 24 adults, of whom 12 will have type 1 diabetes and 12 will have type 2 diabetes. Prior to this study, the next-generation AID system will have been assessed in at least 10 participants with type 1 diabetes in a controlled hotel environment. This study will only proceed if data from that hotel assessment meet pre-specified criteria indicating that the AID system is safe to trial in a home setting. Participants will use the next-generation AID system in their home setting for up to six weeks, following their usual day-to-day routines. They will initially give themselves manual insulin doses before all planned meals. Partway through the study they will stop routinely giving manual insulin doses before meals. Glucose and pump data will be collected throughout the study to assess the performance of the next-generation AID system.
Interventions
The intervention is a next-generation automated insulin delivery (AID) system, which is a modification of the existing commercial Omnipod 5 AID system (Insulet corporation), using a modified version of the Omnipod 5 Pod, modified version of the Omnipod 5 controller, and the commercially available Dexcom G6 continuous glucose monitoring (CGM) system. Compared to the existing Omnipod 5 system, the next-generation system aims to improve the algorithm response to hyperglycaemia while still maintaini
The intervention is a next-generation automated insulin delivery (AID) system, which is a modification of the existing commercial Omnipod 5 AID system (Insulet corporation), using a modified version of the Omnipod 5 Pod, modified version of the Omnipod 5 controller, and the commercially available Dexcom G6 continuous glucose monitoring (CGM) system. Compared to the existing Omnipod 5 system, the next-generation system aims to improve the algorithm response to hyperglycaemia while still maintaining the desired safety profile with regard to hypoglycaemia. Multiple changes have been made to the algorithm accordingly, including allowing the algorithm to operate at a target as low as 5.6 mmol/L, rather than the minimum target of 6.1 mmol/L available in Omnipod 5. This is a single-arm study with 4 phases. Phases 1-3 are described in a separate ANZCTR trial registration (AZTRN12623000623695). Phase 4 will only occur if data from phase 3 meet pre-specified criteria (described in the phase 3 trial registration). During phase 4, participants will use the next generation AID system in their usual home environment for up to 6 weeks. During phase 4 participants will be asked to initially give manual insulin boluses for meals using the Omnipod 5 Pod in accordance with their usual diabetes treatment routine. Partway through phase 4 participants will be asked to stop bolusing for meals, however manual correction boluses should still be given if CGM-detected glucose is >16.7 mmol/L for >one hour. The timing of cessation of mealtime boluses will be determined by investigator discretion, for each individual participant. Participants will attend at least 2 in-person study visits during phase 4. At the first visit, participants who have not previously used the AID system will receive training in its use, including training in how to self-insert and replace the study devices. The study team will monitor blood glucose levels and insulin delivery records in real-time between in-person visits, and will receive real-time alerts for hyperglycaemia, hypoglycaemia, and loss of data. The threshold for these alerts will be determined by investigator discretion and may change during the study. Following each alert, investigators will make contact with participants as needed. This remote review will also be used to monitor adherence to the intervention. For participants with type 1 diabetes, phase 4 may commence immediately after the conclusion of phase 3 (if the pre-specified acceptance criteria are met), or there may be an intervening period between phase 3 and 4 during which participants use their normal diabetes therapy. Participants with type 2 diabetes will not complete phases 2 and 3 of the trial. These participants may commence phase 4 immediately after completing phase 1, or there may be an intervening period between phase 1 and 4 during which participants use their normal diabetes therapy.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent 16+ years 2. Individuals must be diagnosed with type 1 diabetes based on investigator’s clinical judgment for at least 1 year. Individuals diagnosed with type 2 diabetes must be on basal and bolus insulin therapy, with no specified duration. 3. A1C between 7.5-11.0% at screening 4. Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 months prior to study start 5. Willing to use a Dexcom G6 CGM for the duration of the study 6. Willing to use the Omnipod® 5 Automated Insulin Delivery System during the study 7. Willing to perform all fingerstick BG testing with their personal blood glucose meter at the frequency specified in the study protocol or per investigator discretion 8. Willing to use carbohydrate counting for determination of meal boluses 9. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. 10. Willing to adhere to alcohol restriction of no more than 2 standard drinks per day, during Phase 4 of the study
Exclusion criteria
1. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk 2. Blood disorder or dyscrasia within 3 months prior to screening, including the use of hydroxyurea, which in the investigator’s opinion could interfere with determination of HbA1C. 3. History of severe hypoglycemia within the past 6 months 4. History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure 5. History of moderate to severe preproliferative or proliferative retinopathy based on screening within the last 12 months. 6. Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days. 7. Planning to start a weight-loss agent during the study. If on a weight-loss medication, dose must be stable in the previous 30 days. 8. Currently on a low carbohydrate diet of < 60 grams of carbohydrates per day 9. Pregnant, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner) 10. Dermatological conditions at the proposed sensor/pump wear sites that in the investigator’s opinion could preclude ability to wear the Pod and/or the Dexcom sensor 11. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. 12. Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. 13. Currently participating in another clinical study using an investigational drug or device 14. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug 15. Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator’s clinical judgment
Outcome results
None listed