Continuous Glucose Monitoring to Measure Effect of Glycemic Index

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Legacy Health System--Holladay Park Campus

Portland, Oregon, 97232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom Seven® Plus Continuous Glucose Monitoring sensor

Device

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

Primary outcomes

Mean Area Under the Curve for Rise in Breakfast Post-prandial.

Time frame: 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

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.

Sponsors and collaborators

Lead sponsor

Legacy Health System

Other

Collaborators

Juvenile Diabetes Research Foundation

Registry information

Official study title

The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jun 16, 2010
Registry last updated: Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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