Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
With
University of Colorado, Denver
After the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night).
Three predictive algorithm versions were studied sequentially during the study.
Age
12–46
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age 18 years or older,
2. Type 1 diabetes for at least 1 year
3. Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose sensor
4. Hemoglobin A1c level of \< 8.0%,
5. Home computer with access to the Internet,
6. At least one CGMglucose value \< 70 mg/dL during the most recent 15 nights of CGM glucose data.
7. Not pregnant or planning to become pregnant
You may not be if
1. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
2. The presence of any of the following diseases:
* Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
* Cystic fibrosis
* Angina (recurrent heart pain)
* Past heart attack or coronary artery (heart vessel) disease
* Past stroke or impairment of blood flow to the brain
* Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
5. Severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.
