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Continuous Glucose Monitoring to Measure Effect of Glycemic Index 7

Completed
Clinical Trial NCT01145547 was an interventional study for Type 1 Diabetes Mellitus that is now completed. The study started on April 1, 2009, with plans to enroll 7 participants. Led by Legacy Health System, the expected completion date was October 1, 2009. The latest data from ClinicalTrials.gov was last updated on October 23, 2015.
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, bo...

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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-maintainin...Show More
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

Conditions
Type 1 Diabetes Mellitus
Other Study IDs
  • kw01
NCT ID Number
NCT01145547
Start Date (Actual)
2009-04
Last Update Posted
2015-10-23
Completion Date (Estimated)
2009-10
Enrollment (Estimated)
7
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
glycemic index
Diabetes Mellitus
continuous glucose monitoring
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatorlow glycemic index effect on post-prandial peak
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.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Active Comparatorhigh glycemic index effect on post-prandial peak
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.
Dexcom Seven® Plus Continuous Glucose Monitoring sensor
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • clinical diagnosis of type 1 diabetes mellitus
  • patients on insulin pump therapy

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.
Legacy Health System logoLegacy Health System
Juvenile Diabetes Research Foundation logoJuvenile Diabetes Research Foundation
Study Responsible Party
W. Kenneth Ward, Principal Investigator, Senior Scientist, Legacy Health System
No contact data.
1 Study Locations in 1 Countries

Oregon

Legacy Health System--Holladay Park Campus, Portland, Oregon, 97232, United States