Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HealthPartners Institute
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- 4-hour glycemic response at 3 time points
Study Overview
Brief Summary
This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).
The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.
Exclusion Criteria
- •Study participants who are unable to complete the baseline CGM data collection at week -2-
- •Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
Outcomes
Primary Outcomes
4-hour glycemic response at 3 time points
Time Frame: 4 hours
The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings \>180 mg/dL.
Secondary Outcomes
No secondary outcomes reported