Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

Trial ID or NCT#

NCT01973413

Status

not recruiting iconNOT RECRUITING

Purpose

The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

Official Title

Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

Eligibility Criteria

Ages Eligible for Study: 10 Years to 35 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months 2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required. 3. Age 10.0 - 35 years 4. Willingness to use a Sure-T or Contact Detach infusion set while at camp
Exclusion Criteria:
  1. 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. Using an OmniPod insulin infusion pump 5. History of any heart disease including coronary artery disease, heart failure, or arrhythmias 6. Cystic fibrosis 7. Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study. 8. History of ongoing renal disease (other than microalbuminuria). 9. Insulin pump users who supplement with injected intermediate or long acting insulin. 10. Subjects who take other anti-diabetic medications other than insulin.. 11. Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: 12. Inpatient psychiatric treatment in the past 6 months 13. Uncontrolled adrenal disorder 14. Abuse of alcohol 15. Pregnancy (verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned). 16. Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
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Investigator(s)

Bruce Buckingham
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus

View on ClinicalTrials.gov