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Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability (BPK005)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mixed meal and insulin challenge
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Virginia, Center for Diabetes Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin Sensitivity

Arm Description

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

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2011
Last Updated
October 24, 2016
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01439672
Brief Title
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability
Acronym
BPK005
Official Title
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Sensitivity
Arm Type
Experimental
Arm Description
Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed meal and insulin challenge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia, Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

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Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

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