Trial Search Results

Full Day and Night Closed-Loop With DiAs Platform

The overall aim of this proposed research is to determine the safety, feasibility and efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting. This will be addressed in two parts: 1) An in residence, outpatient study to determine safety and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and 2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of Virginia

Collaborator: Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Diabetes Assistant (DiAs) with USS Virginia
  • Other: Sensor Augmented Pump Therapy

Phase:

N/A

Eligibility


Inclusion Criteria: To be eligible for the study, a subject must meet the following
criteria:

   1. 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

   2. Daily insulin therapy for ≥ 12 months

   3. Insulin pump therapy for ≥ 3 months

   4. Age 10.0 - 35.0 years

   5. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the
   continuous glucose monitor.

   6. Willingness to wear a continuous glucose sensor and physiological monitor for the
   duration of the study

   7. 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:

   1. Diabetic ketoacidosis in the past month

   2. Hypoglycemic seizure or loss of consciousness in the past 3 months

   3. History of seizure disorder (except for hypoglycemic seizure)

   4. History of any heart disease including coronary artery disease, heart failure, or
   arrhythmias

   5. Cystic fibrosis

   6. 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.

   7. History of ongoing renal disease (other than microalbuminuria).

   8. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or
   Glargine).

   9. Subjects requiring other anti-diabetic medications other than insulin (oral or
   injectable).

10. Pregnancy - verbal denial of pregnancy obtained with telephone informed consent,
   pregnancy test performed at camp before study devices are assigned.

11. Sexually active females who do not practice acceptable contraceptive methods to
   prevent pregnancy.

12. 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.

13. 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

Ages Eligible for Study

10 Years - 35 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting