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

NCT ID: NCT06182527

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2025-08-12

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CGM Group

Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded. In addition perception of hypoglycemia and counter action will be assessed.

Group Type: EXPERIMENTAL

Free Style Libre Pro IQ

Intervention Type: DEVICE

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

Interventions

Free Style Libre Pro IQ

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• diabetes mellitus
• use of medication interfering with glucose metabolism (steroid, antidiabetic medications)
• surgery of upper GI-tract
• known plaster allergies
• any other clinical condition that would endanger participants safety or question scientific success according to the physicians opinion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Martin Heni

Prof. Martin Heni

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Heni, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

Universityhospital Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

147/2023

Identifier Type: -

Identifier Source: org_study_id