Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes

Overview

Prospective, multicenter, descriptive cohort (RIPH3 study under the Jardé Act), STABILOOP study aims to describe whether BF may be an appropriate therapeutic option for the cohort of patients who are theoretically candidates for Islet transplantation, by describing Closed-Loop failures at 12 months in patients referred to an expert center for management of unstable diabetes.

Primary outcome measures

• Describe Closed Loop (CL) failures at 12 months in patients referred to an expert center for management of unstable diabetes. [Time frame: 12 months]

Secondary outcome measures (12)

• Assess quality of glycaemic control in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess the variation of the glycaemia management index in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess glucose variability in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess glycaemia variability in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess the level of mean glucose in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess hypoglycemia awareness in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months for 1 year then every 6 months for 3 years]
• Assess balance between hypoglycaemia and hyperglycaemia in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess the evolution of insulin requirement in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess glycaemia stability in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years 1st IG, depending on the date of inclusion in the study.]
• Assess renal function in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess occurence of sever diabetic related events in patients treated with Closed Loop (CL) or Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]
• Assess the level of endogenous production of insulin in patients treated with Islet Graft (IG) [Time frame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.]

Eligibility criteria

Inclusion criteria

Type 1 diabetic patients describing:

• Significant glycaemic variability defined by the presence of one of these 3 criteria: - Standard deviation > 50% of the glycaemic mean or a MAGE index > 60 mg/dL
• Coefficient of glycaemic variation > 36%
• LBGI index > 5 or HYPOSCORE > 800
• This glycaemic variability must be persistent, i.e. persist for more than 12 months despite optimal diabetes management by a multi-professional team. Optimum management involves :
• Monitoring by a team with expertise in insulin pump and glucose sensor technologies
• Training patients in functional insulin therapy, intensive self-monitoring of blood glucose levels, and prevention and management of situations where there is a risk of hypoglycaemia
• Use of pump and glucose sensor therapy, with interruption before hypoglycaemia
• Reinforced multi-professional support and monitoring, possibly combined with support via telemedicine.
• This glycaemic variability must be considered as severe, i.e. causing unpredictable clinical and metabolic events that impair quality of life, such as severe, disabling and frequent hypoglycaemia (at least 2 Severe Hypoglycaemia with assistance from a third party in the last 12 months or at least 1 Severe Hypoglycaemia with life-threatening consequences in the last 12 months (coma, convulsions or trauma)) or ketosis ketoacidosis.

Exclusion criteria

• Patients with type 1 diabetes who do not meet the criteria for islet transplantation
• Patients already fitted with a closed loop
• Kidney transplant patients
• Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons)
• Persons opposed to participation in research

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

France · 7 centers

• HCL - Edouard Herriot Hospital — Lyon
• Hospices Civils de Lyon - Lyon Sud — Pierre-Bénite
• Strasbourg Civil Hospital — Strasbourg
• Grenoble University Hospital — La Tronche
• Montpellier University Hospital - Lapeyronnie Hospital — Montpellier
• Toulouse University Hospital - Hôpital Rangueil — Toulouse
• APH Paris - LARIBOISIERE Hospital — Paris

Identifiers

NCT: NCT07006272 · 38RC24.0169

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗