None listed
Conditions
Brief summary
This proposal consists of a two-stage randomized crossover study comparing automated subcutaneous insulin delivery also known as Hybrid Closed Loop (HCL) therapy with usual care and CGM in people with type 1 and type 2 diabetes complicated by advanced renal disease and managed with insulin. Participants will be recruited from three groups: (A) advanced renal disease not on dialysis; (B) those managed with peritoneal dialysis; (C) those managed with haemodialysis in ratios of 2:1:1 respectively. All consented participants will enter a 6-week run-in period where baseline demographic data will be collected, diabetes education and carbohydrate count education provided. During the final three weeks of run-in continuous glucose monitoring (CGM) data will be collected following which HbA1c, and questionnaires assessing psychosocial function will be administered. Participants completing run-in-will receive in random order the Medtronic 780G CL system or usual care with CGM. Each of the two stages will last 8 weeks. For the last 3 weeks of each stage CGM data will be collected. Following each stage blood will be collected for electrolytes and an HbA1c, Questionnaires will be administered. Data will be collected post-randomisation in real-time on HCL technical performance and time spent by the participants on changing insulin-sets and glucose sensors.
Interventions
Participants will be educated in carbohydrate counting by a dietitian and receive diabetes education from a diabetes educator via one-on-one consultations up to 2hours per session. Up to 3 sessions per participant for each of diabetes education and carbohydrate counting education will be provided as required.
This education will occur during the 4-6week run-in period prior to randomisation.
Participants will then be randomised to either trial the Medtronic MiniMed 780G hybrid closed loop insul
Participants will be educated in carbohydrate counting by a dietitian and receive diabetes education from a diabetes educator via one-on-one consultations up to 2hours per session. Up to 3 sessions per participant for each of diabetes education and carbohydrate counting education will be provided as required. This education will occur during the 4-6week run-in period prior to randomisation. Participants will then be randomised to either trial the Medtronic MiniMed 780G hybrid closed loop insulin system or continue their usual care for Stage 1 of the study which will run for a period of 8weeks. If randomised to the Medtronic MiniMed 780G hybrid closed loop system arm, participants will be given a 2-3hour education session on how to use it. Whilst using the Medtronic MiniMed 780G system, participants will be wearing continuous glucose monitoring (CGM) which will communicate with the pump to regulate basal insulin delivery via the system's inbuilt algorithm. Participants will still need to input meal-time carbohydrate content into the pump in order to bolus insulin for each meal. Participants randomised to the usual care arm will continue with their usual insulin delivery mode although doses can be titrated during review visits. Participants in the usual care arm will also wear CGM for the duration of this study stage. All participants will then crossover to the alternate arm of the study for stage 2 regardless of which arm they were randomised to initially. Stage 2 will also run for 8weeks and the protocol is identical to stage 1. There will be no washout period between treatments.
Sponsors
St Vincent's Hospital Mebourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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 •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
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 •Major psychiatric history •On peritoneal dialysis using icodextrin
Outcome results
None listed