Hybrid Closed Loop in Advanced Renal Disease
- Conditions
- Type 2 DiabetesType 1 DiabetesEnd stage renal diseaseCKD IIIB-IVMetabolic and Endocrine - DiabetesRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12622000889752
- Lead Sponsor
- St Vincent's Hospital Mebourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
•Age 18-70 years
•Type 1 Diabetes of at least 1-year duration or insulin requiring Type 2 Diabetes
•Managed with multiple daily insulin injections or insulin pump therapy
•HbA1c <10.5%
•Renal function falls into one of the following 3 groups:
·Group A: Stage 3B and Stage 4 renal failure (eGFR <45 and >15mL/min/1.73m2)
·Group B: ESRD requiring peritoneal dialysis
·Group C: ESRD requiring haemodialysis
•Total daily dose of insulin <200 units
•Participant (and carer where applicable) is fluent in English reading and writing
•Willing to learn how to carbohydrate count and to apply this knowledge
•Have a computer with internet access
•Have access to Smart device with data plan
•Already using a hybrid closed loop system
•On sulphonylureas or SGLT2 inhibitors
•For Group A patients – on metformin or GLP1 analogues outside of regulatory guidelines
•For Group B and C patients – on any non-insulin glucose lowering therapies
•History of diabetic ketoacidosis
•Systemic steroid therapy within past four weeks
•Moderate to severe cognitive impairment precluding the use of insulin pump therapy
•Major allergy to tape or adhesives
•Women who are pregnant or planning pregnancy during the study period
•Major life-threatening illness limiting the participant’s life expectancy to <6 months
•Major psychiatric history
•On peritoneal dialysis using icodextrin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method