Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes (STABILOT)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: best medical care; Procedure: Islet graft

Study type: Interventional

Funder types: Other

Identifiers

NCT02854696

38RC14.453

Details and patient eligibility

About

The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

Full description

The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented insulin pump therapy) for patients with brittle type1 diabetes.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Suffering from diabetes since more than 5 years
• Patient with brittle type 1 diabetes despite an optimized insulin treatment and educational training will be included. A patient will be considered as experiencing a brittle type 1 diabetes if at least two criteria are present among: persistence of severe hypoglycemia, occurrence of ketoacidosis events without obvious etiology, diagnosis of unaware hypoglycemic episodes < 3 mmol/l based on CGM or self-monitoring blood glucose data, a mean blood glucose standard deviation>50%, MAGE index (Mean amplitude of glucose excursions)>60 mg/dl, LBGI index (low blood glucose index)>5, Clarke score≥4 or HYPOSCORE>800.
• Insulin needs < 0,85 U/kg/day
• HbA1c < 12% ;
• No residual insulin secretion (plasmatic basal and stimulated C-peptide < 0.3 ng/ml)
• Social Security membership or benefit from Social Security
• Patients who signed the consent form

Exclusion Criteria :

Exclusion criteria related to islet infusion:

• Hemostatic disorders, pre-existing liver disease (PAL, Gamma-GT, ASAT-ALAT >2N) or vesicular lithiasis.

Exclusion criteria related to diabetic complications:

• Evolutive proliferative retinopathy, evolutive nephropathy (Glomerular filtration rate <30 ml/min/1.73m2 and/or proteinuria >0.5g/day), evolutive cardiopathy or obliterative arteriopathy with trophic cutaneous lesions.

Exclusion criteria related to immunosuppressant use:

• Hemoglobin < 110mg/dL in women and < 120 mg/dL in men, leuconeutropenia, thrombopenia, systemic infection including chronic hepatitis B, C and VIH, neoplasia disease and hypertension>160/100 mmHg.
• Corticoid treatment (except for patient that benefited from a kidney graft with maintenance steroid therapy)
• Presence of anti-HLA antibody directed against the donor
• Positive B or T cells crossmatch

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Islet graft

Experimental group

Description:

Patients who receive islet graft Intervention : Procedure/Surgery

Treatment:

Procedure: Islet graft

Best medical care

Active Comparator group

Description:

Patients who continue their optimal medical treatment (insulin pump therapy coupled with real time continuous glucose monitoring) Intervention : insulin treatment

Treatment:

Drug: best medical care