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

Glycaemic Index Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147273
• Other study ID #: 11
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2023
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Continous Glucose Measurement
• Glycaemic Index
• Postprandial Glucose Response

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Germany	West-German Center of Diabetes and Health	Duesseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Bionorica SE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose response	postprandial glycemic changes after consuming different carbohydrate containing foods	1 and 2 hours after food consumption
Secondary	incremental AUC (AUCi) of postprandial glucose excursions	after consuming different carbohydrate containing foods	1 and 2 hours after food consumption