Hypoglycemia, ReactiveHypoCGMNCT06182527
Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life Using Continuous Glucose Measurement
A study testing Free Style Libre Pro IQ in people with Hypoglycemia, Reactive, run by University of Ulm at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Reactive
- What is being tested?
- Free Style Libre Pro IQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 27 Dec 2023to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
- written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Free Style Libre Pro IQ
- Keywords
- Reactive Hypoglycemia, Oral glucose tolerance test, Continuous glucose monitoring
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Style Libre Pro IQDevice
Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| CGM Group | Experimental | 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. Receives: Device: Free Style Libre Pro IQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hypoglycemia
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
Measured: 14 days
Frequency of hypoglycemia
Number of glucose levels below 70 mg/dl assessed by CGM.
Measured: 14 days
Severity of hypoglycemia
Non-severe hypoglycemia defined as glucose levels < 70 mg/dl but >= 54mg/dl; severe hypoglycemia defined as glucose levels < 54mg/dl assessed by CGM.
Measured: 14 days
Secondary outcomes (7)
Time of occurence of hypoglycemia
Occurence of hypoglycemia during day or night time and correspondence to food intake assessed by CGM.
Measured: 14 days
Perception of hypoglycemia
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.
Measured: 14 days
Time in predefined glucose ranges
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.
Measured: 14 days
Mean glucose levels
Mean glucose levels during monitoring period assessed by CGM.
Measured: 14 days
Glucose variability
Glucose variability during monitoring period assessed by CGM.
Measured: 14 days
Correlation between severity of hypoglycemia during ogtt and hypoglycemia in everyday life
Correlation between severity of hypoglycemia during OGTT and incidence and severity of hypoglycemia in everyday life assessed by CGM.
Measured: Varying time point between oGTT and 14 days of glucose assessment using CGM
Correlation between body composition and hypoglycemia in everyday life
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start27 Dec 2023
- Primary completion22 Jul 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia, ReactiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
- Investigators
- Martin Heni, Prof., Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182527
- Sponsor's protocol ID
- 147/2023
- Acronym
- HypoCGM
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.
- ClinicalTrials.gov ID
- NCT06182527
- Acronym / sponsor ID
- HypoCGM / 147/2023
- Conditions
- Hypoglycemia, Reactive
- Keywords
- Reactive Hypoglycemia, Oral glucose tolerance test, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Group | Experimental | Device: Free Style Libre Pro IQEvery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
- written consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Style Libre Pro IQEvery participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded. | Device | CGM Group |
Primary outcome
Occurrence of hypoglycemia
Time frame: 14 days
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
Frequency of hypoglycemia
Time frame: 14 days
Number of glucose levels below 70 mg/dl assessed by CGM.
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.
7 secondary outcomes
Time of occurence of hypoglycemia
Time frame: 14 days
Perception of hypoglycemia
Time frame: 14 days
Time in predefined glucose ranges
Time frame: 14 days
Mean glucose levels
Time frame: 14 days
Glucose variability
Time frame: 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 body composition and hypoglycemia in everyday life
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Heni, Prof. principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Style Libre Pro IQ in people with Hypoglycemia, Reactive, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of hypoglycemia (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.