Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01439672

Run by

University of Virginia

People needed

35

Starts

2010-08-01

Expected to finish

2012-03-01

Last updated by the study team

2016-12-06

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Virginia, Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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