Trials Sponsors Conditions Drugs Pricing

Conditions

Hypoglycemia, Reactive

Keywords

Reactive HypoglycemiaOral glucose tolerance testContinuous glucose monitoring

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

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.

Device: Free Style Libre Pro IQ

Interventions

Free Style Libre Pro IQDevice

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

CGM Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

University of Ulm
Otherlead

Study Sites (1)

Universityhospital Ulm

Ulm, 89081, Germany

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Martin Heni, Prof.
University Hospital Ulm
PRINCIPAL INVESTIGATOR

Enrollment

21 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (1)

CGM Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (1)

CGM Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations