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Continuous Glucose Monitoring to Measure Effect of Glycemic Index

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT01145547
First received: June 15, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.

Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.

Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.


Condition Intervention
Type 1 Diabetes Mellitus
 Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • magnitude of post-prandial glucose levels [ Time Frame: 5 and 15 minute intervals ] [ Designated as safety issue: No ]
    Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals for three hours after the start of each meal.


Enrollment: 7
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
 Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Active Comparator: high glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
 Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Detailed Description:

A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinical diagnosis of type 1 diabetes mellitus
  • patients on insulin pump therapy

Exclusion Criteria:Any patient who was

  • pregnancy
  • cardiovascular, cerebrovascular, kidney, or liver disease
  • uncontrolled chronic medical conditions
  • oral or parenteral corticosteroid use
  • immunosuppressant use
  • visual or physical impairments that impede the use of a continuous glucose monitoring device
  • insulin or glucagon allergy
  • hypoglycemia unawareness
  • requirement of greater than 200 units of insulin per day
  • gastroparesis
  • any prior gastric surgery
  • an allergy to any food items served.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145547

Locations
United States, Oregon
Legacy Health System--Holladay Park Campus
Portland, Oregon, United States, 97232
Sponsors and Collaborators
Legacy Health System
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: W K Ward, MD Legacy Health System
  More Information

No publications provided

Responsible Party: W. Kenneth Ward M.D., Legacy Health System
ClinicalTrials.gov Identifier: NCT01145547     History of Changes
Other Study ID Numbers: kw01
Study First Received: June 15, 2010
Last Updated: June 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
glycemic index
Diabetes Mellitus
continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013