Collection of Breath and Sweat to Identify Indicators of Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT03600116|
Recruitment Status : Unknown
Verified November 2018 by Steven J. Russell, MD, PhD, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Insulin Lispro||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collection of Breath and Sweat to Identify Indicators of Hypoglycemia|
|Actual Study Start Date :||May 24, 2018|
|Actual Primary Completion Date :||November 20, 2018|
|Estimated Study Completion Date :||January 2020|
Subjects will arrive to the study visit having fasted the night before. Subjects will be given an insulin injection based on their meal to carbohydrate ratio for their breakfast meal as well as a correction bolus to correct their current plasma glucose value down to 40 mg/dL. Following the insulin injection, subjects will eat breakfast. Blood, breath, and sweat samples will be collected throughout the study visit with increased frequency of collection during 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.
Drug: Insulin Lispro
Subjects will be given an insulin injection with insulin lispro (Humalog) to correct them for their breakfast meal and to correct their plasma glucose value down to 40mg/dL.
Other Name: Humalog
- Identification of Volatile Organic Chemical Indicators of Hypoglycemia [ Time Frame: Up to 12 months ]Exploration via chemical analysis of clinical samples taken from diabetics' breath and sweat, using gas chromatograph-mass spectrometry (GC-MS) and liquid chromatograph-mass spectrometry (LC-MS), to determine the volatile organic compounds whose varying concentrations might correlate with diabetics' blood sugar concentrations in the normoglycemic and hypoglycemic ranges.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600116
|United States, Massachusetts|
|Massachusetts General Hospital (MGH) Diabetes Research Center|
|Boston, Massachusetts, United States, 02114|