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 diabetes. This study investigates a new AID system that does not require people to announce meals with an estimation of the carbohydrate content before they eat. The system has been tested using computer simulations on thousands of “virtual” people with diabetes and has shown to be safe, however, this is the first time it will be used in people. Additionally, some people with type 2 diabetes require insulin as a component of therapy and would therefore potentially benefit from AID, however existing trials of AID in type 2 diabetes are very limited. The study will include 40 adults with diabetes (both type 1 and type 2). The duration of the study is approximately 14 weeks. During the first two weeks of the study subjects will continue with their usual diabetes treatment and in addition will wear a blinded continuous glucose monitor. For the remaining 12 weeks of the study they will use the new automated delivery system. The system consists of an insulin pump, a continuous glucose monitor (CGM), which is worn as a small sensor in subject’s skin, and a maths program (Dexcom next generation algorithm) installed in an app on an Android phone. At set times during the 12 weeks automatic updates will occur to the maths programme in order to optimise the subjects’ average glucose levels. Subjects will be able to view their glucose readings and research staff will regularly monitor subjects’ glucose readings and pump information for safety throughout the study. In addition to CGM and pump data, clinical, diabetic, demographic and psychosocial information will also be collected. There is also a qualitative component of the research where a sub-group of subjects will be invited to take part in an interview at the start and end of the study to gain an understanding of the factors important to quality of life for subjects; the impact of living with diabetes on those important factors; and the impact of the novel intervention on both diabetes and broader quality of life.
Interventions
The intervention is a new, next generation, algorithm for automated insulin delivery developed by Dexcom (inControl Auto). This is a closed loop system using a Dexcom G6 continuous glucose monitor, Ypsomed insulin pump, and Google Pixel Android handset. Unlike previous hybrid systems (where users need to announce meals with an estimation of carbohydrate content of a meal), this algorithm is fully automated and aims to maximise time in sensor glucose range (3.9-10.0 mmol/L) without the need for
The intervention is a new, next generation, algorithm for automated insulin delivery developed by Dexcom (inControl Auto). This is a closed loop system using a Dexcom G6 continuous glucose monitor, Ypsomed insulin pump, and Google Pixel Android handset. Unlike previous hybrid systems (where users need to announce meals with an estimation of carbohydrate content of a meal), this algorithm is fully automated and aims to maximise time in sensor glucose range (3.9-10.0 mmol/L) without the need for meal announcement. Study participants will have their diabetes treated by this algorithm for a 12-week period. Under the control of the algorithm, insulin will be delivered continuously by the Ypsomed pump. The dosage of insulin will be individualised to the patient (by the algorithm) in order to maximise the time that sensor-detected glucose is in the target range (3.9-10.0 mmol/L). The devices (Dexcom G6 continuous glucose monitor and Ypsomed insulin pump) will be continuously active throughout the 12-week period, as will the algorithm under investigation. The automated nature of the system means that no user input is required from participants other than wearing the device. Participant adherence will be verified through review of device data (glucose recordings and recorded insulin delivery). Qualitative interviews will be held with a sub-group of participants within the 14-day run-in period and within 14 days of the participant completing the study, to gain understanding of the factors important to quality of life for participants; the impact of living with diabetes on those important factors; and the impact of the novel intervention on both diabetes and broader quality of life. Interviews will be held using an electronic platform that works for both investigator and participant. Experienced qualitative researchers who have conducted a number of diabetes studies and are mindful of the complexities associated with diabetes and its psychosocial impact will conduct the interviews. Interviews will be held with a sub-group of participants, n=10-12 in total. A purposive sampling approach will be taken to ensure representation across participants in terms of ethnicity, gender, diabetes duration, age.
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. Type 1 or type 2 diabetes mellitus, diagnosed > 6 months prior to the screening visit 2. Have never used an automated insulin delivery system 3. HbA1c 58 mmol/mol or greater within the 6 months prior to the screening visit 4. Total daily basal insulin requirement compatible with basal rate allowed by inControl Auto algorithm 5. Willing and able to adhere to the study protocol 6. Have daily access to a Wi-Fi network
Exclusion criteria
1. Pregnant or planning to become pregnant while participating in the study 2. Alcohol or drug dependence (as reported by participants) 3. Severe visual impairment that would impair use of the devices 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 of Humalog® and NovoRapid® insulin
Outcome results
None listed