Collection of Breath and Sweat to Identify Indicators of Hypoglycemia
Status: | Active, not recruiting |
---|---|
Conditions: | Endocrine, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/5/2018 |
Start Date: | May 24, 2018 |
End Date: | January 2020 |
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.
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.
The investigators will measure volatile organic compounds in breath and sweat of participants
with type 1 diabetes with normoglycemia and induced hypoglycemia to determine if there is a
relationship between VOC signature and hypoglycemia. The investigators will administer an
insulin injection to provoke mild hypoglycemia and thereby increase the number of breath and
sweat samples collected under hypoglycemic conditions.
with type 1 diabetes with normoglycemia and induced hypoglycemia to determine if there is a
relationship between VOC signature and hypoglycemia. The investigators will administer an
insulin injection to provoke mild hypoglycemia and thereby increase the number of breath and
sweat samples collected under hypoglycemic conditions.
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
We found this trial at
1
site
55 Fruit Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Principal Investigator: Steven J Russell, MD, PhD
Phone: 617-724-6237
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