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Continuous Glucose Monitoring to Measure Effect of Glycemic Index

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring glycemic index, Diabetes Mellitus, continuous glucose monitoring

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Legacy Health System--Holladay Park Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low glycemic index effect on post-prandial peak

high glycemic index effect on post-prandial peak

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2010
Last Updated
October 2, 2015
Sponsor
Legacy Health System
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01145547
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
glycemic index, Diabetes Mellitus, continuous glucose monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low glycemic index effect on post-prandial peak
Arm Type
Active Comparator
Arm 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.
Arm Title
high glycemic index effect on post-prandial peak
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
Intervention Description
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Primary Outcome Measure Information:
Title
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Description
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.
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W K Ward, MD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Health System--Holladay Park Campus
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States

12. IPD Sharing Statement

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Continuous Glucose Monitoring to Measure Effect of Glycemic Index

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