Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

NCT03600116 | Completed

• 1 other identifier: 2018P000868
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Identification of Volatile Organic Chemical Indicators of Hypoglycemia

  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.

  Up to 12 months

Study Arms (1)

Study Visit

After consent and enrollment, subjects with type 1 diabetes 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. 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who fit the selection criteria will be considered as candidates for this study. The study team will contact individuals who have previously inquired about participation in our studies and have asked to have their contact information kept on file. In addition, advertisements for the study may be posted at the MGH Diabetes Center and other places, and may be distributed in the weekly broadcast email of research studies seeking volunteers. A letter may be sent to adult endocrinologists in the Boston metropolitan as well as selected nearby endocrinologists informing them of the study and asking them to refer any eligible patients who might be interested.

You may qualify if:

• Informed consent by the subject documented prior to any study procedures
• Age ≥ 18 years
• Have had clinical type 1 diabetes for at least one year
• Willing and able to avoid deodorant, scented lotions, and scented laundry detergent on your clothes on the day of the visit

You may not qualify if:

• Unable to provide informed consent (e.g. impaired cognition or judgment)
• Unable to safely comply with study procedures and reporting requirements (e.g. impaired memory or unable to speak and read English)
• Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
• Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
• Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
• Acceptable contraception methods include:
• Oral contraceptive pill (OCP)
• Intrauterine Device (IUD, hormonal or copper)
• Male condoms
• Female condoms
• Diaphragm or cervical cap with spermicide
• Contraceptive patch (such as OrthoEvra)
• Contraceptive implant (such as Implanon, Nexplanon)
• Vaginal ring (such as NuvaRing)
• Progestin shot (such as Depo-Provera)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mitre Medical Corp.: collaborator

Study Sites (1)

Massachusetts General Hospital (MGH) Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breath and sweat samples will be collected and shipped to the collaborator, the MITRE Corporation, for analysis. Blood samples will be collected to measure plasma glucose, but will be discarded after the measurement is completed.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 26, 2018
• Study Start: May 24, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: March 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)