Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Grenoble
Treatments:
Insulin
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 scoreā‰„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