Continuous Glucose Monitoring to Measure Effect of Glycemic Index

NCT ID: NCT01145547

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-10-31

Brief Summary

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.

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dexcom Seven® Plus Continuous Glucose Monitoring sensor

Intervention Type: DEVICE

A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

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.

Group Type: ACTIVE_COMPARATOR

Dexcom Seven® Plus Continuous Glucose Monitoring sensor

Intervention Type: DEVICE

A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Interventions

Dexcom Seven® Plus Continuous Glucose Monitoring sensor

A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Legacy Health System

OTHER

Sponsor Role: lead

Responsible Party

W. Kenneth Ward

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

W K Ward, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Health System

Locations

Legacy Health System--Holladay Park Campus

Portland, Oregon, United States

Countries

United States

Other Identifiers

kw01

Identifier Type: -

Identifier Source: org_study_id