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

Hypoglycemia, Reactive Clinical Trial

— HypoCGM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182527
• Other study ID #: 147/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Ulm
• Contact: Julia Hummel, PhD
• Phone: +4973150044744
• Email: julia.hummel[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 period of 14 days in affected persons.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Hypoglycemia, Reactive

Intervention

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

Locations

Country	Name	City	State
Germany	Universityhospital Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of hypoglycemia	Occurrence of glucose levels below 70 mg/dl assessed by CGM.	14 days
Primary	Frequency of hypoglycemia	Number of glucose levels below 70 mg/dl assessed by CGM.	14 days
Primary	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	Time of occurence of hypoglycemia	Occurence of hypoglycemia during day or night time and correspondence to food intake assessed by CGM.	14 days
Secondary	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.	14 days
Secondary	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.	14 days
Secondary	Mean glucose levels	Mean glucose levels during monitoring period assessed by CGM.	14 days
Secondary	Glucose variability	Glucose variability during monitoring period assessed by CGM.	14 days
Secondary	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.	Varying time point between oGTT and 14 days of glucose assessment using CGM
Secondary	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.	14 days