Glucose, High Blood Clinical Trial
Official title:
Assessments of Hybrid Closed Loop and Fully Automated Closed Loop Dose Safety Artificial Pancreas Device in Type 1 Diabetes in a Hospital Clinical Research Setting
Verified date | February 2019 |
Source | Dose Safety Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 population of subjects with type 1 diabetes (TID) in a hospital CRC setting. The first mode is the Fully Automated Closed Loop (FACL) mode, in which all insulin delivery is directed by the controller and the second mode is the Hybrid Closed Loop (HCL) mode, in which insulin delivery is a hybrid between controller directed delivery and user directed insulin delivery. There will be two study arms: HCL and FACL. No comparisons will be made between the two arms.
Status | Suspended |
Enrollment | 20 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dose Safety | Redmond | Washington |
Lead Sponsor | Collaborator |
---|---|
Dose Safety Inc. | Benaroya Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time in hypoglycemic range | defined as <70 mg/dL | 36 hours | |
Primary | Percentage of time in severe hyperglycemic range | defined as >/=250 mg/dL | 36 hours |
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