N/A
Completed N=32
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
| Outcome | Result | p-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.
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.