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

NCT04147273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-03

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Bionorica SE

    collaborator INDUSTRY

  • West German Center of Diabetes and Health

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147273 on ClinicalTrials.gov