The Performance of an Artificial Pancreas at Home in People with Type 1 Diabetes.
- Conditions
- Type 1 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12614000035628
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Adults aged greater than 14 years able to provide informed consent.
- T1 Diabetes for a minimum of 6 months (fasting C-peptide levels less than 50 pmol/L).
- HbA1c less than 8.5%.
- Experience with a continuous glucose sensor with established basal insulin infusion patterns, insulin to carbohydrate ratios, regular use of the insulin bolus calculator, can insert/ change sensor by themselves, can recharge transmitter, and has experience in reading real time continuous glucose monitoring (RT-CGM) data.
- Accurate carbohydrate counting.
- Experience in uploading pump information to web.
- Residing in Melbourne or Perth.
- Willing to comply with the study protocol requirements inclusive of those requirements related to participant safety.
- Requiring greater than 150 units of insulin/day.
- Diabetic ketoacidosis (DKA) within the past 4 weeks.
- Hypoglycaemic unawareness (Gold score = 4) while on SAPT
- More than 2 severe hypoglycaemic episodes within the last 12 months
- Pregnant or planning pregnancy within study period.
- Renal impairment (eGFR less than 60ml/min).
- Current or recent (less than 4 weeks) inhaled or oral steroid therapy.
- Dermatological conditions (eg psoriasis) involving the region of glucose sensor/ insulin delivery cannula insertion.
- Subject has physical limitations (eg impaired vision) that would compromise operation of the closed loop system.
- Currently involved in another investigational study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method