NCT06182527

Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life Using Continuous Glucose Measurement

Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research project aims to investigate the everyday relevance of reactive hypoglycemia (hypoglycemia after a glucose load) in the oral glucose tolerance test (OGTT). Therefore, blood glucose profiles in everyday life will be examined using continuous glucose measurement (Free Style Libre PRO IQ system) over a period of 14 days in affected persons.

Detailed description

The aim of this analysis is to examine people who underwent an OGTT due to various endocrinological and metabolic issues and developed reactive hypoglycemia, defined as a drop in blood glucose \<70mg/dl during the course of the test. During OGTT routine laboratory testing will be performed as part of routine clinical practice. In order to investigate the occurrence and perception of hypoglycaemia in the everyday lives of those affected, their blood glucose profiles will be recorded and evaluated over a period of 14 days. In addition, the perception of (suspected) hypoglycemia and counteraction will be documented. Anthropometric data will be recorded and a bioelectrical impedance analysis performed to check a correlation with the body composition. Subjects will be recruited via the endocrinology outpatient clinic as part of medical care. To date, very little CGM data are available on the frequency and extent of reactive hypoglycemia in the everyday lives of people without diabetes mellitus. Therefore, 20 subjects with hypoglycemia in the OGTT will be included in this exploratory pilot study for hypothesis generation in order to investigate the occurrence and perception of hypoglycemia in everyday life.

Conditions

• Hypoglycemia, Reactive

Interventions

Type	Name	Description
DEVICE	Free Style Libre Pro IQ	Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded.

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-07-22
• Completion: 2025-08-12
• First posted: 2023-12-27
• Last updated: 2025-12-10

Locations

1 site across 1 country: Germany