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N/A N=35 Treatment

Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

Type 1 Diabetes Mellitus

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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