An interventional study of Free Style Libre Pro IQ in Hypoglycemia, Reactive, sponsored by University of Ulm. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University of Ulm · Not applicable, Interventional, and Screening
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.
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.
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's enrollment of 21 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Occurrence of hypoglycemia
Occurrence of glucose levels below 70 mg/dl assessed by CGM.
Time frame: 14 days
Frequency of hypoglycemia
Number of glucose levels below 70 mg/dl assessed by CGM.
Time frame: 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.
Time frame: 14 days
Time of occurence of hypoglycemia
Occurence of hypoglycemia during day or night time and correspondence to food intake assessed by CGM.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
Mean glucose levels
Mean glucose levels during monitoring period assessed by CGM.
Time frame: 14 days
Glucose variability
Glucose variability during monitoring period assessed by CGM.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Ulm