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

Last updated: March 20, 2025
Sponsor: University of Ulm
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Hormone Deficiencies

Treatment

Free Style Libre Pro IQ

Clinical Study ID

NCT06182527
147/2023
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • hypoglycemia during a 75 g oral glucose tolerance test defined as glucose levelbelow 70 mg/dl at timepoint 180 min.

  • written consent

Exclusion

Exclusion Criteria:

  • diabetes mellitus

  • use of medication interfering with glucose metabolism (steroid, antidiabeticmedications)

  • surgery of upper GI-tract

  • known plaster allergies

  • any other clinical condition that would endanger participants safety or questionscientific success according to the physicians opinion

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Free Style Libre Pro IQ
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Universityhospital Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

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