Diabetes MellitusNCT02131766
USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
A study testing DiAs and Sensor Augmented Pump Therapy in people with Diabetes Mellitus, run by University of Virginia at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- DiAs and Sensor Augmented Pump Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Mount Sinai Hospital
New York, New York, 10029-6574
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Overnight Control in Type 1 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- DiAs, Sensor Augmented Pump Therapy
- Keywords
- Diabetes Mellitus, Type 1, Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiAsDevice
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.
Sensor Augmented Pump TherapyOther
Also called SAP
Insulin pump plus CGM.
| Study group | Role | What they receive |
|---|---|---|
| USS Virginia Closed Loop Control | Experimental | 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. Receives: Device: DiAs |
| Sensor Augmented Pump Therapy | Placebo comparator | 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. Receives: Other: Sensor Augmented Pump Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
USS Virginia Time Within Target
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.
Measured: 40 hours
Secondary outcomes (3)
Overnight Target Range
Assess time spent within target range of 80-140 mg/dl overnight with USS Virginia Closed Loop compared to sensor-augmented pump therapy alone
Measured: 40 hours
Decreased Overnight Hypoglycemia
Assess the effect of USS Virginia Closed Loop System to decrease hypoglycemia overnight compared to sensor-augmented pump therapy alone
Measured: 40 hours
Morning Glucose Levels
Assess the distribution of wake-up glucose levels at 07:00 achieved by USS Virginia Closed Loop vs. to sensor-augmented pump therapy alone;
Measured: 40 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of VirginiaCarol Levy, MD, CDE, Principal investigator, MOUNT SINAI HOSPITALYogish C. Kudva, MBBS, MD, Principal investigator, Mayo ClinicClaudio Cobelli, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131766
- Sponsor's protocol ID
- 17351
- Other IDs
- 1DP3DK101055-01
- Status last verified
- Mar 2020
- First submitted
- 2 May 2014
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undetermined
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Overnight Control in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02131766
- Acronym / sponsor ID
- 17351
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 1, Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USS Virginia Closed Loop Control | Experimental | Device: DiAsThe 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. |
| Sensor Augmented Pump Therapy | Placebo comparator | Other: Sensor Augmented Pump TherapyThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiAsDiAs 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. | Device | USS Virginia Closed Loop Control |
| Sensor Augmented Pump TherapyAlso: SAPInsulin pump plus CGM. | Other | Sensor Augmented Pump Therapy |
Primary outcome
USS Virginia Time Within Target
Time frame: 40 hours
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.
3 secondary outcomes
Overnight Target Range
Time frame: 40 hours
Decreased Overnight Hypoglycemia
Time frame: 40 hours
Morning Glucose Levels
Time frame: 40 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Undetermined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Brown, MD principal investigator
University of Virginia
Carol Levy, MD, CDE principal investigator
MOUNT SINAI HOSPITAL
Yogish C. Kudva, MBBS, MD principal investigator
Mayo Clinic
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiAs and Sensor Augmented Pump Therapy in people with Diabetes Mellitus, run by University of Virginia at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USS Virginia Time Within Target (time frame: 40 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020; AzTrials last refreshed its copy on 30 Oct 2026.