Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness (Islet transplantation for insulin-dependent diabetes mellitus )

Not provided0 sites20 target enrollmentStarted: October 13, 2013Last updated: May 30, 2022

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Enrollment: 20
Primary Endpoint: HbA1c<7.4% and free of severe hypoglycemic events

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional
Allocation: Single Arm Study
Intervention Model: Single Assignment
Primary Purpose: Treatment Purpose
Masking: Open(masking Not Used)

Eligibility Criteria

Ages: 20age old over to 65age old under (—)
Sex: All

Inclusion Criteria

•Male or female; 20 to 65 years of age.
•Ability to provide written informed consent.
•Mentally stable and able to comply with the procedures of the study protocol.
•Clinical history compatible with type 1 diabetes with insulin dependence for > 5 years at the time of the registration.
•Absent stimulated C-peptide (< 0.3 ng/mL)
•Involvement in intensive diabetes management defined as the self monitoring of glucose values no less than a mean of three times each day, averaged over each week, and the administration of three or more insulin injections each day or insulin pump therapy. Such management must have been subjected to at least 3 clinical evaluations during the previous 12 months.
•At least one episode of severe hypoglycemia in the past 12 months defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level < 54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
•At least once evaluated glycemic lability status by a Clarke score, a HYPO score and a glycemic lability index (LI) score.

Exclusion Criteria

•BMI > 25 kg/m2 or weight > 80 kg.
•Insulin requirement of > 0.8 IU/kg/day or 55 U/day.
•Mean HbA1c value of several measurements in the previous 12 months > 10%.
•Untreated proliferative diabetic retinopathy.
•Blood pressure: SBP > 160 mmHg or DBP > 100 mmHg.
•Creatinine clearance < 60 mL/min (applied only to islet transplantation alone case)
•Presence of proteinuria > 1 g/day.
•For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: Intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
•Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation.
•Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
•Difficulty of administration for laboratory and physical tests for evaluation or regular outpatient visits.
•Mental abnormalities to hinder medical procedure under protocol (Assessment by psychiatrists is required and final decision is made by investigators in charge)
•Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Outcomes

Primary Outcomes

HbA1c<7.4% and free of severe hypoglycemic events

Time Frame: from day 90 to day 365 one years after the first islet cell infusion

The proportion of subjects with HbA1c<7.4% and who are free of severe hypoglycemic events (from day 90 to day 365) one years after the first islet cell infusion.

Secondary Outcomes

Proportion of patients with HbA1c (NGSP) <7.4% and severe hypoglycemic unawareness disappears(2 years after the first transplantation)
Proportion of patients with severe hypoglycemic attack unawareness
Proportion of patients with HbA1c value (NGSP)<7.4%(two years after the first transplantation)
Proportion of patients with HbA1c value (NGSP value) <6.9%(two years after the first transplantation)
Percentage of patients with insulin withdrawal(2 years after the first transplantation)

Investigators

Sponsor

Not provided

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