N/A
N=35
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01439672 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Insulin Sensitivity — 3.37*10^-4 1/min per uU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mixed meal and insulin challenge (Dietary_supplement)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
3.37*10^-4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 1.5) or uncontrolled hypertension (resting blood pressure >140/90).
Data sourced from ClinicalTrials.gov (NCT01439672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.