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)

未提供0 个研究点目标入组 10 人开始时间: 待定最近更新: 2022年3月31日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 10
主要终点: HbA1c < 7.4% and free of severe hypoglycemic events

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 65age old under（—）
性别: All

入选标准

•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 (< 0.3ng/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.

排除标准

•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 > 1g/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.

结局指标

主要结局

HbA1c < 7.4% and free of severe hypoglycemic events

时间窗: 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)

次要结局

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) < 6.9%(two years after the first transplantation)
Percentage of patients with insulin withdrawal(2 years after the first transplantation)

研究者

发起方

未提供

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