Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type1diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 7 years and 80 years
- Gender
- Both males and females
Description
Insulin delivery systems are an increasingly popular treatment option for Type I Diabetes (T1D). Delivery systems consist of an insulin pump, a glucose sensor with a transmitter attached, and a maths program (algorithm) built into the pump. The algorithm uses sensor glucose levels to decide how much...
Insulin delivery systems are an increasingly popular treatment option for Type I Diabetes (T1D). Delivery systems consist of an insulin pump, a glucose sensor with a transmitter attached, and a maths program (algorithm) built into the pump. The algorithm uses sensor glucose levels to decide how much insulin should be delivered by the pump. This study aims to see how well a new algorithm controls blood glucose levels in T1D. The study uses the MiniMed 670G 4.0 insulin pump and compares two different algorithms: Advanced Hybrid Closed Loop (AHCL - the new algorithm) Sensor augmented pump therapy with predictive low-glucose management (SAP with PLGM). Approximately 60 participants with T1D, aged 7 - 80 years, will take part in the study. Every participant will receive the following two treatment algorithms in random order, with a two-week washout between treatments: MiniMed 670G 4.0 insulin pump in AHCL mode for 4 weeks. MiniMed 670G 4.0 insulin pump in SAP + PLGM mode for 4 weeks. During the study insulin pump data will be uploaded and changes in health will be monitored. In addition, participants will complete 3-day food diaries and a number of questionnaires. Participants at the Dunedin site will also be asked to complete home sleep studies during the trial (optional). The results of the study will be used to further develop insulin delivery systems. It is hoped this may improve treatment for people with diabetes.
Tracking Information
- NCT #
- NCT04073576
- Collaborators
- Medtronic
- Investigators
- Not Provided