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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free Style Libre Pro IQ | Device | Every participant receives a Free Style Libre Pro IQ sensor for 14 days. Glucose levels will be recorded. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of occurence of hypoglycemia | Occurence of hypoglycemia during day or night time and correspondence to food intake assessed by CGM. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Heni, Prof. | University Hospital Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universityhospital Ulm | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Every participant receives a Freestyle Libre PRO IQ Sensor, a system which ensures blinding of the glucose levels to the participants.
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| 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. | 14 days |
| Mean glucose levels | Mean glucose levels during monitoring period assessed by CGM. | 14 days |
| Glucose variability | Glucose variability during monitoring period assessed by CGM. | 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. | 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. | 14 days |