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N/A Completed N=32 Randomized Treatment

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

Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01973413 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Percent Time Near Normoglycemia — 73; 52 percentage of time — p==0.037

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Time Near Normoglycemia
73; 52 =0.037 sig
SECONDARY
Overnight Glucose
140; 147 =0.340
SECONDARY
Glycemic Events
4; 4; 7; 14

Eligibility Criteria

Inclusion Criteria

  • 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
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
  • Age 10.0 - 35 years
  • Willingness to use a Sure-T or Contact Detach infusion set while at camp

Exclusion Criteria

  • 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)
  • Using an OmniPod insulin infusion pump
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • Cystic fibrosis
  • 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.
  • History of ongoing renal disease (other than microalbuminuria).
  • Insulin pump users who supplement with injected intermediate or long acting insulin.
  • Subjects who take other anti-diabetic medications other than insulin..
  • 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 disorder
  • Abuse of alcohol
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01973413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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