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USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT02131766•University of Virginia

View on ClinicalTrials.gov

Summary

The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol will test the feasibility of "bedside" closed-loop control - an approach comprised of standard sensor-augmented pump therapy during the day using off-the-shelf devices and overnight closed-loop control using experimental devices in an outpatient setting. The rationale for this study is as follows: we anticipate that closed-loop control may ultimately be adopted by patients with T1DM in a selective manner. Patient may choose to start using these systems for overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while asleep. To test this paradigm of "bedside" closed-loop control, subjects will be studied with continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by overnight use of USS Virginia Closed Loop Control.

Detailed Description

The subject will participate in both the Experimental and the Control Admissions. The order of the two admissions will be randomized. During the Control Admission at home, the subject will use the study insulin pump along with a continuous glucose monitor receiver. During the Experimental Admission, the subject will be the research house/hotel where the subject will be in control of the DiAs. Participation in this study will require 5 study visits over 11-14 weeks.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. Age ≥21 to \<65 years
•3. HbA1c \<10.0%
•4. 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.
•5. Demonstration of proper mental status and cognition for the study
•6. Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
•7. Ability to access the Internet and upload CGM data via the DexCom company software during the data collection period.
•8. Willingness to remain within approximately 30 miles radius of study site during the day time hours of Visit 4.
+4 more criteria

Exclusion Criteria

•1. Admission for diabetic ketoacidosis in the 12 months prior to enrollment
•2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
•3. History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
•4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
•5. Cystic fibrosis
•6. 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
+15 more criteria

Locations (4)

Mayo Clinic

Rochester, Minnesota, United States

Mount Sinai Hospital

New York, New York, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

University of Padova

Padua, Italy

Key Dates

Start Date

June 1, 2014

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

April 16, 2020

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

DiAs

DEVICE

Sensor Augmented Pump Therapy

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

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