A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Vancouver Coastal Health

Status: Withdrawn

Conditions: Islet Transplantation; Diabetes Mellitus, Type 1

Treatments: Other: Strict glucose control

Study type: Interventional

Funder types: Other

Identifiers

NCT01123122

VGHEndo0510

Details and patient eligibility

About

Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years of age
• more than 5 years since diagnosis of diabetes
• c-peptide negative

Exclusion criteria

• ischemic heart disease
• previous transplant
• recurrent infections
• malignancy (except basal or squamous skin cancer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Strict glucose control

Active Comparator group

Treatment:

Other: Strict glucose control

Standard glucose control

No Intervention group