N/A
N=7
Continuous Glucose Monitoring to Measure Effect of Glycemic Index
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01145547 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Mean Area Under the Curve for Rise in Breakfast Post-prandial. — 61; 583 min x (mmol/l)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom Seven® Plus Continuous Glucose Monitoring sensor (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Legacy Health System
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area Under the Curve for Rise in Breakfast Post-prandial. |
61; 583 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01145547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.