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

This study has been withdrawn prior to enrollment.
Information provided by:
Vancouver Coastal Health
ClinicalTrials.gov Identifier:
First received: May 13, 2010
Last updated: March 31, 2015
Last verified: May 2011
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.

Condition Intervention
Diabetes Mellitus, Type 1
Islet Transplantation
Other: Strict glucose control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Resource links provided by NLM:

Further study details as provided by Vancouver Coastal Health:

Primary Outcome Measures:
  • Islet cell function [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Function will be assessed three months post-transplantation.

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strict glucose control Other: Strict glucose control
Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
No Intervention: Standard glucose control


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01123122

Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver Coastal Health
Principal Investigator: David M Thompson, MD Vancouver General Hospital Department of Endocrinology and Metabolism
  More Information


Responsible Party: David M. Thompson, Vancouver General Hospital Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01123122     History of Changes
Other Study ID Numbers: VGHEndo0510 
Study First Received: May 13, 2010
Last Updated: March 31, 2015
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 26, 2016