- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131766
USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Overnight Control in Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Padova, Italy, 35131
- University of Padova
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New York
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New York, New York, United States, 10029-6574
- Mount Sinai Hospital
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Center for Diabetes Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months
- Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL ii. Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL iii. HbA1c ≥6.5% documented iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes.
- Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually iii. Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
- Age ≥21 to <65 years
- HbA1c <10.0%
- For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
- Demonstration of proper mental status and cognition for the study
- Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
- Ability to access the Internet and upload CGM data via the DexCom company software during the data collection period.
- Willingness to remain within approximately 30 miles radius of study site during the day time hours of Visit 4.
- An understanding of and willingness to follow the protocol and sign the informed consent
Additional Inclusion Criteria for UVA subjects only who participate in the 5 days at-home portion
- Availability of a significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and available to provide assistance when system is being used at night
- Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of the period of time using the closed-loop system at home.
- Access to internet and cell phone service at home
Exclusion Criteria:
- Admission for diabetic ketoacidosis in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
- Cystic fibrosis
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
- Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
- Active gastroparesis
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
- Abuse of alcohol or recreational drugs
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Oral steroids
- Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- Basal Rates <0.01 units/hour.
Current use of the following drugs and supplements:
- Acetaminophen
- Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, glucagon-like peptide (GLP)-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
- Beta blockers
- Any other medication that the investigator believes is a contraindication to the subject's participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: USS Virginia Closed Loop Control
The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM. A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission. |
DiAs is the central component of our system.
It is a standard cell phone running on an Android operating system.
The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off.
The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.
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PLACEBO_COMPARATOR: Sensor Augmented Pump Therapy
The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods).
The subject will follow their usual regimen.
The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week.
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Insulin pump plus CGM.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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USS Virginia Time Within Target
Time Frame: 40 hours
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Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.
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40 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overnight Target Range
Time Frame: 40 hours
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Assess time spent within target range of 80-140 mg/dl overnight with USS Virginia Closed Loop compared to sensor-augmented pump therapy alone
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40 hours
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Decreased Overnight Hypoglycemia
Time Frame: 40 hours
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Assess the effect of USS Virginia Closed Loop System to decrease hypoglycemia overnight compared to sensor-augmented pump therapy alone
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40 hours
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Morning Glucose Levels
Time Frame: 40 hours
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Assess the distribution of wake-up glucose levels at 07:00 achieved by USS Virginia Closed Loop vs. to sensor-augmented pump therapy alone;
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40 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carol Levy, MD, CDE, Mount Sinai Hospital
- Principal Investigator: Yogish C. Kudva, MBBS, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17351
- 1DP3DK101055-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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