NCT04147273

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: West German Center of Diabetes and Health · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2019-11-01
• Last updated: 2023-05-03

Locations

1 site across 1 country: Germany