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Clinical Trials/ACTRN12622000889752
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.

Registry
who.int
Start Date
June 22, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
St Vincent's Hospital Mebourne

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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