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Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

Clinical Trial Summary

Subjects with type 1 diabetes will be observed in the diabetes research center clinic following a meal and an insulin injection. Breath and sweat samples will be collected at intervals throughout the visit, with increased frequency during hypoglycemia. Collaborators with the MITRE Corporation will perform analyses on these samples to identify any relationships between volatile organic compounds in breath and sweat and hypoglycemia.

Clinical Trial Description

Subjects enrolled in the study will have clinical type 1 diabetes managed with rapid acting insulin. After consent and enrollment, they will arrive to the study visit having fasted the night before. Subjects will be given a meal, and will be given an insulin injection for this meal, calculated based on their prescribed meal to carbohydrate ratio as well as a correction bolus to correct their current plasma glucose value down to 40 mg/dL based on their prescribed insulin sensitivity factor. Following the insulin injection, subjects will eat breakfast and be observed in the clinic setting. Blood, breath, and sweat samples will be collected throughout the study visit with increased frequency of collection during hypoglycemia. Collaborators with the MITRE Corporation will perform analyses on these samples to identify any relationships between volatile organic compounds in breath and sweat and hypoglycemia. After subjects reach the hypoglycemia threshold, they will be allowed to eat and drink and their blood sugar will be monitored for stability prior to discharge. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03600116
Study type Observational
Source Massachusetts General Hospital
Contact
Status Completed
Phase
Start date May 24, 2018
Completion date November 20, 2018
View Details
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