Continuous Glucose Monitoring to Measure Effect of Glycemic Index

Legacy Health System

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT01145547

kw01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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7 participants in 2 patient groups

low glycemic index effect on post-prandial peak

Active Comparator group

Description:

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.

Treatment:

Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor

high glycemic index effect on post-prandial peak

Active Comparator group

Description:

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.

Treatment:

Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor