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

December 3, 2025 updated by: Martin Heni, University of Ulm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • Universityhospital Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Free Style Libre Pro IQ
Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of hypoglycemia
Time Frame: 14 days
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
14 days
Frequency of hypoglycemia
Time Frame: 14 days
Number of glucose levels below 70 mg/dl assessed by CGM.
14 days
Severity of hypoglycemia
Time Frame: 14 days
Non-severe hypoglycemia defined as glucose levels < 70 mg/dl but >= 54mg/dl; severe hypoglycemia defined as glucose levels < 54mg/dl assessed by CGM.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of occurence of hypoglycemia
Time Frame: 14 days
Occurence of hypoglycemia during day or night time and correspondence to food intake assessed by CGM.
14 days
Perception of hypoglycemia
Time Frame: 14 days
Incidence of typical symptoms of hypoglycemia perceived by the participant, documented in a protocol with free-text fields handed out to the participant during 1st study visit.
14 days
Time in predefined glucose ranges
Time Frame: 14 days
Time spent in the following glucose ranges: time above range: >140mg/dl; time in range: 71-140mg/dl; time below range: <70mg/dl; time with severe hypoglycemia: <54mg/dl assessed by CGM.
14 days
Mean glucose levels
Time Frame: 14 days
Mean glucose levels during monitoring period assessed by CGM.
14 days
Glucose variability
Time Frame: 14 days
Glucose variability during monitoring period assessed by CGM.
14 days
Correlation between severity of hypoglycemia during ogtt and hypoglycemia in everyday life
Time Frame: Varying time point between oGTT and 14 days of glucose assessment using CGM
Correlation between severity of hypoglycemia during OGTT and incidence and severity of hypoglycemia in everyday life assessed by CGM.
Varying time point between oGTT and 14 days of glucose assessment using CGM
Correlation between body composition and hypoglycemia in everyday life
Time Frame: 14 days
Correlation between body composition (assessed by bioelectrical impedance analysis and anthropometric measurements) and incidence as well as severity of hypoglycemia in everyday life assessed by CGM.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Martin Heni, Prof., University Hospital Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Actual)

July 22, 2025

Study Completion (Actual)

August 12, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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