Clinical trial NCT00884611: Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
Official title: Development of Algorithms for a Hypoglycemic Prevention Alarm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2009-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.

The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

The exclusion criteria for this study is the following:

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.

Primary outcomes:
measure: Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL
timeFrame: 21 days
Secondary outcomes:
measure: Percentage of Nights With CGM Values >180 mg/dL
timeFrame: 21 days
measure: Mean Morning Blood Glucose (BG)
timeFrame: 21 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes, University of Colorado
state: Colorado
Study officials:
affiliation: Stanford University
name: Bruce A. Buckingham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckingham BA, Cameron F, Calhoun P, Maahs DM, Wilson DM, Chase HP, Bequette BW, Lum J, Sibayan J, Beck RW, Kollman C. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-7. doi: 10.1089/dia.2013.0040. Epub 2013 Jul 24.