Full Day and Night Closed-Loop With DiAs Platform
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor (CGM), Insulin Pump
Eligibility Criteria
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
Sites / Locations
- Stanford University
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Sensor Augmented Pump Therapy
Diabetes Assistant (DiAs) with USS Virginia
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.
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.