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Completed

NCT Number: NCT06182527

Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universityhospital Ulm

Ulm, 89081, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free Style Libre Pro IQ

Device

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

Primary outcomes

  1. Occurrence of hypoglycemia

    Time frame: 14 days

    Occurrence of glucose levels below 70 mg/dl assessed by CGM.

  2. Frequency of hypoglycemia

    Time frame: 14 days

    Number of glucose levels below 70 mg/dl assessed by CGM.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Mean glucose levels

    Time frame: 14 days

    Mean glucose levels during monitoring period assessed by CGM.

  5. Glucose variability

    Time frame: 14 days

    Glucose variability during monitoring period assessed by CGM.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Acronym: HypoCGM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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