Clinical trial NCT01145547: Continuous Glucose Monitoring to Measure Effect of Glycemic Index
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: glycemic index
Diabetes Mellitus
continuous glucose monitoring
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2010-06-16
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Mean Area Under the Curve for Rise in Breakfast Post-prandial.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Health System--Holladay Park Campus
state: Oregon
Study officials:
affiliation: Legacy Health System
name: W K Ward, MD
role: PRINCIPAL_INVESTIGATOR
References: