Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life Using Continuous Glucose Measurement
HypoCGM
Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 27, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2025
CompletedDecember 10, 2025
December 1, 2025
1.6 years
November 27, 2023
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Occurrence of hypoglycemia
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
14 days
Frequency of hypoglycemia
Number of glucose levels below 70 mg/dl assessed by CGM.
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.
14 days
Secondary Outcomes (7)
Time of occurence of hypoglycemia
14 days
Perception of hypoglycemia
14 days
Time in predefined glucose ranges
14 days
Mean glucose levels
14 days
Glucose variability
14 days
- +2 more secondary outcomes
Study Arms (1)
CGM Group
EXPERIMENTALEvery 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.
Interventions
Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded.
Eligibility Criteria
You may qualify if:
- hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
- written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universityhospital Ulm
Ulm, 89081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Heni, Prof.
University Hospital Ulm
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Every participant receives a Freestyle Libre PRO IQ Sensor, a system which ensures blinding of the glucose levels to the participants.
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Martin Heni
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 27, 2023
Study Start
December 27, 2023
Primary Completion
July 22, 2025
Study Completion
August 12, 2025
Last Updated
December 10, 2025
Record last verified: 2025-12