Continuous Glucose Monitoring to Measure Effect of Glycemic Index

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145547
• Other study ID #: kw01
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: October 2, 2015
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Legacy Health System--Holladay Park Campus	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Legacy Health System	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Area Under the Curve for Rise in Breakfast Post-prandial.	Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.	Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast	No