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

NCT ID: NCT04147273

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-05-31

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.

Conditions

Postprandial Glucose Response; Glycaemic Index; Continous Glucose Measurement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Evaluation of CGM compared with standard measurements

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.

Group Type: OTHER

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

Intervention Type: 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).

Interventions

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

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bionorica SE

INDUSTRY

Sponsor Role: collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role: lead

Responsible Party

Stephan Martin

Director of the West German Center of Diabetes and Health, Head of Diabetology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West-German Center of Diabetes and Health

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

11

Identifier Type: -

Identifier Source: org_study_id