Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting

Not Applicable

Completed

• Conditions: Postprandial Glucose Response; Glycaemic Index; Continous Glucose Measurement
• Interventions: Device: Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods

• Registration Number: NCT04147273
• Lead Sponsor: West German Center of Diabetes and Health

Brief Summary

Self-monitoring of blood glucose using capillary glucose testing has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood as a reference. Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Detailed Description

Self-monitoring of blood glucose using capillary glucose testing (C) has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood (IV) as a reference. Postprandial blood glucose levels were measured after 50 g oral glucose load and after the consumption of a portion of different foods containing 50 g of carbohydrates. We also evaluated the associations between postprandial glucose responses and the clinical characteristics of the participants at the beginning of the study. Incremental area under the curve (AUCi) of postprandial blood glucose was calculated for 1 h (AUCi 0-60) and 2 h (AUCi 0-120). Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-11-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• 18-80 years old

Exclusion Criteria

• acute diseases, severe illness with in-patient treatment during the last 3 months, weight change >2 kg/week during the last month, smoking secession during the last 3 months, drugs for active weight reduction, chronic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of CGM compared with standard measurements	Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods	Two products were studied: white bread (Butter Toast®, Golden Toast, Wittenberg, Germany) and whole grain bread (1688 Mehrkorn®, Harry-Brot, Schenefeld, Germany). One portion (containing 50 g digestible carbohydrates) was eaten immediately before the beginning of the test in the morning after an overnight fast of at least 10 h. Before testing, participants ate as usual on the previous day without a standard meal and refrained from consuming alcohol and exercising for 72 h. A 200-ml glucose drink (Accu-Chek Dextrose O.G.-T. Saft®, Roche Diabetes Care, Mannheim, Germany), containing also 50 g of carbohydrates, was used as the reference product.

Primary Outcome Measures

Name	Time	Method
Postprandial glucose response	1 and 2 hours after food consumption	postprandial glycemic changes after consuming different carbohydrate containing foods

Secondary Outcome Measures

Name	Time	Method
incremental AUC (AUCi) of postprandial glucose excursions	1 and 2 hours after food consumption	after consuming different carbohydrate containing foods

Trial Locations

Locations (1)

West-German Center of Diabetes and Health; 🇩🇪 Duesseldorf, Germany