Status:
SUSPENDED
Dose Safety Hybrid Closed Loop and Fully Automated Closed Loop Artificial Pancreas Device in CRC
Lead Sponsor:
Dose Safety Inc.
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Benaroya Research Institute
Conditions:
Glucose, Low Blood
Glucose, High Blood
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a popul...
Detailed Description
3.1 Overview Two independent questions will be addressed in this study. For evaluation of the safety and efficacy of the hybrid closed loop (HCL), participants will use the hybrid closed loop during a...
Eligibility Criteria
Inclusion
- Participants must have type 1 diabetes for greater than 1 year
- Have a hemoglobin A1c less than 9.0%
- Participants in the FACL arm must report that they engage in aerobic exercise at least 30 minutes three times weekly
- If participants in the FACL arm are age \>35 OR duration of T1D \>15 years OR history of T1D complications (proliferative retinopathy, nephropathy, peripheral vascular disease, autonomic neuropathy), participant must have EKG within normal limits obtained within last 6 months of study date
- Age 18-70
- Fluent and literate in English
- Use of an insulin pump for ≥ 3 months
- Use of a CGM/sensor for ≥ 5 days/week for ≥3 months
- Must have a diabetes care provider
- Use of an effective birth control method for women who are sexually active and of childbearing potential
- Willing and able to give informed consent
Exclusion
- History of ≥ 1 episode of severe hypoglycemia (defined as hypoglycemia leading to loss of consciousness, seizure, or requiring assistance) in the previous 6 months
- History of ≥ 1 episode of DKA in the previous 6 months
- History of cardiovascular disease, characterized by any of the following:
- Prolonged QT or arrhythmia
- History of myocardial infarction within the past 6 months
- History of ischemia on functional cardiac exam within the last year
- History of left ventricular ejection fraction \< 30%
- Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
- Current use of a beta blocker
- Stage 3 or greater renal disease
- Untreated thyroid disease
- History of substance abuse
- Current or previous use of medications for control of a seizure disorder
- Enrolled in another clinical trial in which they received investigational drug in the last 12 weeks
- Inability to comply with protocol
- Pregnant or breast feeding
- Use of medications other than insulin to control glucose
- Chronic corticosteroid use
- Pre-existing medical conditions deemed by study investigator to interfere with the study or increase risks of study participation.
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03428295
Start Date
June 22 2017
End Date
August 31 2019
Last Update
February 12 2019
Active Locations (1)
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1
Dose Safety
Redmond, Washington, United States, 98052