Continuous Glucose Monitoring to Measure Effect of Glycemic Index
The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedOctober 23, 2015
October 1, 2015
6 months
June 15, 2010
September 1, 2015
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
low glycemic index effect on post-prandial peak
ACTIVE COMPARATORSeven 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.
high glycemic index effect on post-prandial peak
ACTIVE COMPARATORSeven 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.
Interventions
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
Eligibility Criteria
You may qualify if:
- clinical diagnosis of type 1 diabetes mellitus
- patients on insulin pump therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Legacy Health Systemlead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
Legacy Health System--Holladay Park Campus
Portland, Oregon, 97232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- W. Kenneth Ward
- Organization
- Legacy Health System
Study Officials
- PRINCIPAL INVESTIGATOR
W K Ward, MD
Legacy Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 16, 2010
Study Start
April 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
October 23, 2015
Results First Posted
October 5, 2015
Record last verified: 2015-10