N/A
N=22
Medtronic Treat to Range (TTR) Closed-Loop Control
Diabetes Mellitus · Type 1 Diabetes · Metabolic and Nutritional Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01490151 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions — 7; 4; 7; 2 Admissions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TTR controller (Medtronic) (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions |
7; 4; 7; 2; 3; 2 | — |
Summary
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
- Age 15 years to less than 30 years old.
- HbA1c 140 on screening; Diastolic blood pressure >90 on screening
- History of seizure or loss of consciousness in the last 6 months.
- Adhesive allergies; Active skin condition that would affect sensor placement
- History of heart disease
- Active Graves disease;
- Currently on beta blocker medication;
- Unwilling or unable to follow the protocol;
- History of diagnosed medical eating disorder;
- History of known illicit drug abuse or prescription drug abuse;
- History of current alcohol abuse;
- History of visual impairment which would not allow subject to participate
- Currently participating in an investigational study (drug or device);
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Data sourced from ClinicalTrials.gov (NCT01490151). 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.