Status:
COMPLETED
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21-64 years
Phase:
NA
Brief Summary
This protocol will investigate physiological parameters including insulin sensitivity and counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with type I diabetes.
Detailed Description
The principal idea of the proposed research is: in order to be successful, closed-loop control of glucose in diabetes must adapt to individual physiologic characteristics and to the behavioral profile...
Eligibility Criteria
Inclusion
- Type I diabetes mellitus (TIDM) (as defined by the American Diabetes Association criteria or judgment of a physician) for at least two years prior to the enrollment in the study.
- Use of an insulin pump to treat their diabetes for at least six months prior to the study.
- Ability to use a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
- Age 21 - 64 years. Adults age 65 and over are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia.
- Completed Phase 1 of the Institutional Review Board (IRB) #14956 "Development of a Behavioral Observer for Type 1 Diabetes Mellitus"
- Willingness to use lispro (Humalog) insulin two days prior to and during inpatient admission.
- Willingness to perform Self-Monitoring Blood Glucose (SMBG) 4 times per day at times before meals and bedtime.
- Demonstration of proper mental status and cognition for completion of the study.
Exclusion
- Pregnancy
- Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse)
- History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Known bleeding diathesis or dyscrasia
- Active enrollment in another clinical trial
- Medical condition that would make operating an insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted).
- Anemia (hematocrit \<36% \[females\], \<38% \[males\]),
- Allergy or adverse reaction to lispro (Humalog) insulin
- Conditions which may increase the risk of induced hypoglycemia such as symptomatic heart disease, congestive heart failure, history of a cerebrovascular event, atrial fibrillation, renal insufficiency (creatinine \>1.5) or uncontrolled hypertension (resting blood pressure \>140/90).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01439672
Start Date
August 1 2010
End Date
March 1 2012
Last Update
December 6 2016
Active Locations (1)
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1
University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903