Older Adult Closed Loop (ORACL) Study for Type 1 Diabetes
- Conditions
- type 1 diabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12619000515190
- Lead Sponsor
- St Vincent's Hospital Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1) Type 1 diabetes of >=10 years duration
2) Using insulin pump therapy (>=1 year pump experience) with established pump settings
3) HbA1c <=10.5%
4) Able to use study devices (with or without caregiver assistance)
1) Non-type 1 diabetes
2) Use of closed-loop insulin delivery within past 3 months
3) Nephropathy with eGFR <30 mL/min/1.73m^2 or on dialysis
4) Use of any glucose-lowering agent other than insulin within past 3 months
5) Corticosteroid medication within past 3 months (or anticipated during the study period)
6) Inability to tolerate skin adhesives
7) History of myocardial infarction, severe uncontrolled heart failure, unstable angina, transient ischaemic attack, stroke, or thromboembolic disease in past 3 months
8) Clinical diagnosis of moderate or severe dementia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of time spent with sensor glucose 3.9–10.0 mmol/L[Final 3 months of each study stage]
- Secondary Outcome Measures
Name Time Method