Status:
COMPLETED
Development of a Behavioral Observer for Type 1 Diabetes Mellitus
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well as translational...
Detailed Description
This intensive descriptive study will follow 60 adults with T1DM who are currently experienced with insulin pump use for a two-week training period plus a one month active study period during which th...
Eligibility Criteria
Inclusion
- Type 1 Diabetes Mellitus (as defined by the American Diabetes Association criteria or judgment of a physician) for at least two years prior to the enrollment in the study.
- Use of an insulin pump to treat their diabetes for at least six months.
- Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
- Age 21 - 65 years. The investigators will not be studying children since the DexCom Seven® Plus is not approved for use in children. Adults over age 65 are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia.
- Willingness to participate in the study for 6 weeks wearing a DexCom Seven® Plus CGM and OmniPod® insulin pump, performing self-monitoring blood glucose (SMBG) with the integral FreeStyle glucometer 4 times per day (before meals and bedtime) in addition to SMBG required to calibrate the CGM or to validate a low or high BG alarm (\<70 mg/dl or \>300 mg/dl), and recording behavioral events by tagging SMGB values throughout the study with meal and activity descriptors.
- Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.
- Demonstration of proper mental status and cognition for completion of the study.
Exclusion
- Pregnancy
- Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse)
- History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Known bleeding diathesis or dyscrasia
- Active enrollment in another clinical trial
- Medical requirement for acetaminophen-containing products during the study period for more than 1 week
- Medical condition that would make operating a CGM or insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted).
- Need for magnetic resonance imaging (MRI)/magnetic resonance angiogram (MRA) during the study.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01434030
Start Date
April 1 2010
End Date
June 1 2011
Last Update
September 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia - Center for Diabetes Technology
Charlottesville, Virginia, United States, 22901