Investigating everyday hypoglycemia after glucose intake using continuous glucose monitoring
Evaluation of the Everyday Relevance of Reactive Hypoglycemia in the Oral Glucose Tolerance Test Using Continuous Glucose Measurement.
NA · University of Ulm · NCT06182527
This study is testing how often people without diabetes experience low blood sugar after eating sugar and how it affects their daily lives by using a continuous glucose monitor for two weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm (other) |
| Locations | 1 site (Ulm) |
| Trial ID | NCT06182527 on ClinicalTrials.gov |
What this trial studies
This research project examines the everyday relevance of reactive hypoglycemia, which occurs after a glucose load during an oral glucose tolerance test (OGTT). Participants who experience a drop in blood glucose levels below 70 mg/dl will have their glucose profiles monitored continuously for 14 days using the Free Style Libre PRO IQ system. The study aims to document the occurrence and perception of hypoglycemia in daily life, alongside routine laboratory testing and anthropometric data collection. This exploratory pilot study will include 20 subjects to generate hypotheses regarding the frequency and impact of reactive hypoglycemia in individuals without diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals who experience reactive hypoglycemia during an OGTT and can provide written consent.
Not a fit: Patients with diabetes mellitus or those on medications that interfere with glucose metabolism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and understanding of reactive hypoglycemia in everyday life.
How similar studies have performed: While there is limited data on continuous glucose monitoring in individuals without diabetes, this approach is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ulm
- Universityhospital Ulm — Ulm, Germany (RECRUITING)
Study contacts
- Principal investigator: Martin Heni, Prof. — University Hospital Ulm
- Study coordinator: Julia Hummel, PhD
- Email: julia.hummel@uniklinik-ulm.de
- Phone: +4973150044744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoglycemia, Reactive, Reactive Hypoglycemia, Oral glucose tolerance test, Continuous glucose monitoring