Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

NCT ID: NCT01439672

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-03-31

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 of each person. We propose to build a system that will use observers of patients' behavior and metabolic state and control modules that are responsible for insulin delivery and hypoglycemia prevention. In this phase of the project, we will investigate relationships of insulin sensitivity and impaired counterregulation with blood glucose variability, aiming to develop algorithmic physiology observers, which will track specific parameters of glucose variability and recurrent hypoglycemia as markers of change in a person's insulin sensitivity and counterregulatory ability.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Sensitivity

Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.

Group Type: EXPERIMENTAL

Mixed meal and insulin challenge

Intervention Type: DIETARY_SUPPLEMENT

The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to \~100mg/dl at 1100.

Interventions

Mixed meal and insulin challenge

The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to \~100mg/dl at 1100.

Intervention Type: DIETARY_SUPPLEMENT

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 <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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sue Brown

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sue Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia, Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

R01DK085623

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15131

Identifier Type: -

Identifier Source: org_study_id