ACTRN12622000889752
Not yet recruiting
未知
Efficacy and Safety of Glucose Control with a Next Generation Hybrid Closed Loop (HCL) System in Adults with Diabetes and Advanced Renal Disease
St Vincent's Hospital Mebourne0 sites40 target enrollmentJune 22, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- St Vincent's Hospital Mebourne
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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