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

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Type 1 Diabetes (T1D)

Study type

Observational

Funder types

Other

Identifiers

NCT07006272

38RC24.0169

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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