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

NCT04147273 | Completed

• 1 other identifier: 11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Glucose Response; Glycaemic Index; Continous Glucose Measurement

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose response

  postprandial glycemic changes after consuming different carbohydrate containing foods

  1 and 2 hours after food consumption

Secondary Outcomes (1)

• incremental AUC (AUCi) of postprandial glucose excursions

  1 and 2 hours after food consumption

Study Arms (1)

Evaluation of CGM compared with standard measurements

OTHER

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.

Device: Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods

Interventions

Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods DEVICE

One day prior to the study beginning, participants were equipped with a CGM system (FreeStyle Libre®, Abbott Diabetes Care, Alameda, CA, USA). This CGM system provides glucose recordings every 15 min over a period of 14 days. The glucose data were downloaded manually by a scan with a handheld device. On the second day of the study, participants consumed portions of these three test products containing 50 g of available carbohydrate on 3 separate days without a washout period. The products were tested in random order at the same time of the morning after a 10 h overnight fast. Venous blood samples were collected at 0, 15, 30, 45, 60, 75, 90, 105 and 120 min postprandial by inserting an intravenous cannula into a forearm vein. Capillary blood samples were obtained through finger pricking. Blood glucose levels in these samples were measured with a high quality SMBG system (ContourXT/Contour next, Ascensia Diabetes Care, Leverkusen, Deutschland, Germany).

Evaluation of CGM compared with standard measurements

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• West German Center of Diabetes and Health: lead
• Bionorica SE: collaborator

Study Sites (1)

West-German Center of Diabetes and Health

Düsseldorf, 40591, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the West German Center of Diabetes and Health, Head of Diabetology

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: November 1, 2019
• Study Start: December 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)