- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02147860
Full Day and Night Closed-Loop With DiAs Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is an early feasibility study that will test the efficacy of DiAs - a smart-phone-based system compared to sensor augmented therapy in an outpatient setting. Twelve study subjects with type 1 diabetes, six each at UVa and Stanford University, who have experience with insulin pump use at two clinical sites will be recruited. The first six subjects recruited will be aged 15-18 years and this will follow with recruitment of six subjects aged 10-14 years. This study is designed to mimic the protocol at camp and will include a period of light exercise after breakfast and moderate intensity physical activity after lunch, with group activities such as soccer and volleyball. The duration of the Outpatient in Residence Study will be 72 hours. The data will be reviewed by the Data Safety Monitoring Board (DSMB) before proceeding to camp studies.
The camp study will recruit 48 subjects, with type 1 diabetes who have experience with insulin pump therapy. Initial studies will be conducted at a camp with older participants aged 15-35 years, with at least 5 of the campers between 15-18 years old. These studies will be reviewed by the DSMB and, if safe, we will recruit additional children aged 10-14 years of age. The duration of the Diabetes Camp Studies will be up to 7 days/6 nights.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 93405
- Stanford University
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Center for Diabetes Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: To be eligible for the study, a subject must meet the following criteria:
Clinical diagnosis of type 1 diabetes
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age 10.0 - 35.0 years
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
- Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD)
Exclusion Criteria: The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Pregnancy - verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned.
- Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/hotel admission if these criteria are not met. The camp study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Sensor Augmented Pump Therapy
Each camp participant will be randomized to full day and night CLC or sensor augmented pump therapy for up to 7 days/6 nights.
The subject will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.
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Subjects randomized to this placebo group will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.
Other Names:
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Experimental: Diabetes Assistant (DiAs) with USS Virginia
With the use of the UVA Artificial Pancreas (DiAs), the study will assess safety and feasibility and are not powered for statistical significance. These studies are intended to train staff on system function and obtain data regarding safe and feasible system use. Camp participants will be randomized to either closed-loop control using the DiAs or sensor-augmented pump therapy only. These studies would generate up to 120 days of closed-loop data and 120 comparable days of open-loop data. |
DiAs is the central component of our system.
It is a standard cell phone running on an Android operating system.
The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off.
The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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DiAs time within target
Time Frame: 7 days/6 nights
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Determine the efficacy of glucose control, as determined by the percentage of sensor glucose readings in the target range
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7 days/6 nights
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17375
- 2014PG-T1D038 (Other Identifier: The Leona M. & Harry B. Helmsley Charitable Trust Grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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