Collection of Breath and Sweat to Identify Indicators of Hypoglycemia

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Mitre Medical Corp.
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Male partner with a vasectomy proven to be effective by semen analysis

• Abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.

• History of hypoglycemic seizures (grand mal) or coma in the last year

• History of poor venous access or inadequate venous access as determined by trial nurse or physician at time of screening

• Hemoglobin < 12 g/dl for men, < 11 g/dl for women

• Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study