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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04147273
Enrollment
12
Registered
2019-11-01
Start date
2018-12-01
Completion date
2019-05-31
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continous Glucose Measurement, Glycaemic Index, Postprandial Glucose Response

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.

Interventions

DEVICEDetermination 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

Bionorica SE
CollaboratorINDUSTRY
West German Center of Diabetes and Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glucose response1 and 2 hours after food consumptionpostprandial glycemic changes after consuming different carbohydrate containing foods

Secondary

MeasureTime frameDescription
incremental AUC (AUCi) of postprandial glucose excursions1 and 2 hours after food consumptionafter consuming different carbohydrate containing foods

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026