Type 1 Diabetes MellitusNCT02302963
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
A study of Type 1 Diabetes Mellitus, run by University of Virginia at 2 sites in United States.
Trial summary
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Jan 2017
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least 1 year. For an individual to be enrolled at least one criterion from each list must be met:
- Criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥126 mg/dL (confirmed)
- Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL (confirmed)
- HbA1c ≥6.5% (confirmed)
- Random glucose ≥200 mg/dL with symptoms
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- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes or in the opinion of the investigator participant has history consistent with type 1 diabetes.
- Criteria for requiring insulin at diagnosis (at least 1 must be met):
- Participant required insulin at diagnosis and continually thereafter
- 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
- Participant required 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 thereafter
- Use of insulin for the last 12 months or more
- Use of an insulin infusion pump for the last 6 months or longer
- Age 12-70 years old
- HbA1c <10.0% as measured with DCA2000 or equivalent device; if HbA1c <6.0% then total daily insulin must be ≥0.5 U/kg
- Risk of hypoglycemia or hypoglycemia unawareness as defined by any of the following:
- Clarke Hypoglycemia Perception Awareness questionnaire score of ≥4.
- Average Daily Risk Range (ADRR) >40 as assessed from Self-Monitoring Blood Glucose (SMBG) readings from the prior month. Subject must have a glucometer that can be downloaded for this assessment. The subjects may alternatively provide a spreadsheet of their past 30 days of blood glucose values.
- Low Blood Glucose Index (LBGI) >2.5 as assessed from SMBG from the prior month or LBGI >1.1 as assessed from 1 week of CGM readings from the prior three weeks. Subject must have a glucometer or CGM that can be downloaded for this assessment. For the glucometer data, the subjects may alternatively provide a spreadsheet of their past 30 days of blood glucose values.
- Subject reports no recognition of hypoglycemia until the glucose is <60 mg/dL and no adrenergic symptoms at glucose of 60 mg/dL (shakiness, palpitations, diaphoresis).
- Able to speak and read English and use basic technology such as a cell phone.
- Currently using an insulin-to-carbohydrate ratio to calculate meal bolus sizes.
- Access to Internet or cell phone service in the subject's local environment.
- Willingness to maintain uninterrupted availability via personal cell phone at all times during the study.
- Willingness to perform SMBG testing 4-6 times daily (before meals, about 2 hours after meals and at bedtime, before driving, before exercise, and as indicated) during the interventional phases of the study.
- Living with a diabetes care partner ≥18 years old who meets the following inclusion criteria:
- Committed to potentially (if randomized to DiAs) participating in all training activities involving DiAs components and emergency procedures,
- Knowledgeable at all times of the participant's location during the day when closed loop is in use,
- Committed to maintaining uninterrupted availability via personal cell phone,
- Being present and available to provide assistance when the closed loop system is being used at night,
- Able to speak and read English and use basic technology such as a cell phone, and
- Absence of 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,
- Current or recent abuse of alcohol or recreational drugs by history
- 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.
Who cannot join
- The presence of any of the following is an exclusion for the study:
- Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment.
- Hematocrit less that the lower limit of normal for the assay.
- Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures; 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.
- Conditions which may increase the risk of induced hypoglycemia such as: known coronary artery disease, congestive heart failure, history of any cardiac arrhythmia (benign premature atrial contractions and premature ventricular contractions allowed), history of seizure disorder, history of cerebrovascular event or transient ischemic attack, hypoglycemia-induced migraine within the last 6 months, or neurological disease.
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- 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 for either the subject or the subject's diabetes care partner
- Presence of a known adrenal disorder
- Abnormal liver function tests (transaminase >3 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 (estimated Glomerular filtration rate (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 mIU/L); testing required within 3 months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
- Current or recent abuse of alcohol or recreational drugs by patient history
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
- Any skin condition in the area of insertion that prevents safe sensor or pump placement (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
- Diagnosed with celiac disease and not currently following a gluten free diet
- 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
- Current use of any of the following drugs and supplements:
- Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, Glucagon-like peptide-1 (GLP-1) Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
- Beta blockers
- Oral glucocorticoids
- Pseudoephedrine
- Any other medication that the investigator believes is a contraindications to the subject's participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Stanford University
Stanford, California, 94305
About this study
Official title: Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Hypoglycemia Reduction in Type 1 Diabetes
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of the control system in reducing hypoglycemia by comparing, in a randomized study, 24 hour control with USS Virginia versus sensor augmented pump (SAP) therapy in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia. We will also evaluate the effectiveness of the control system to improve hypoglycemia counterregulation, hypoglycemia awareness, and overall glycemic control. To achieve this goal, we will conduct pre- and post-intervention inpatient assessments of hypoglycemia counterregulation and symptom awareness. Subjects randomized to USS Virginia will participate in two training visits at a monitored outpatient setting for the step-wise deployment of the cell phone based Artificial Pancreas (AP) System at home. The first training visit includes training on the study pump and AP System followed by 1 week use of AP System at home in Pump mode. The second training visit includes additional training on USS Virginia+AP System and confirmation of independent use by the subject followed by 4 week use of the AP System at home in Closed Loop mode. Subjects randomized to sensor-augmented pump therapy will complete 5 weeks of CGM with the home pump.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- AP System (DiAs or inControl) with USS Virginia, Sensor-Augmented Pump Therapy (placebo)
- Keywords
- Diabetes Mellitus, Type 1 (T1DM), Diabetes Assistant (DiAs), Artificial Pancreas (AP) System, Closed-Loop Control (CLC), Unified Safety System (USS) Virginia, Sensor Augmented Pump (SAP), Low Blood Glucose Index (LBGI), Continuous Glucose Monitor (CGM), inControl Diabetes Management Platform
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP System (DiAs or inControl) with USS VirginiaDevice
Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
Sensor-Augmented Pump Therapy (placebo)Device
Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
| Study group | Role | What they receive |
|---|---|---|
| AP System (DiAs or inControl) with USS Virginia | Experimental | Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home. Receives: Device: AP System (DiAs or inControl) with USS Virginia |
| Sensor-Augmented Pump Therapy | Placebo comparator | Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home. Receives: Device: Sensor-Augmented Pump Therapy (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hypoglycemia During Closed Loop Control (Assessed by Low Blood Glucose Index [LBGI])
Change in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention. The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI will be higher for someone with a higher percentage of low blood glucose readings or more extreme hypoglycemic episodes. Reference: Kovatchev BP. Metrics for Glycaemic Control: from HbA1c to Continuous Glucose Monitoring. Nature Reviews Endocrinology 2017; 13: 425-436. PMID: 28304392
Measured: 2 weeks total: one week of baseline blinded use to compute LBGI-Pre versus use during the last week of intervention to compute LBGI-Post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, TypeZero Technologies, LLC
- Responsible party
- Sponsor
- Investigators
- Stacey M. Anderson, MD, Principal investigator, UVA Center for Diabetes TechnologyBruce Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302963
- Sponsor's protocol ID
- 17725
- Other IDs
- 1DP3DK101055
- Status last verified
- Sep 2022
- First submitted
- 24 Nov 2014
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, \& exercise will be deidentified \& retrievable only by subject ID number. The data's real value lies in their precise time stamps - each reading is coded by date \& time which makes possible the data to be related to the subjects' daily routine. Individual patterns of demographic \& insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Data can be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes \& not to identify participants; (2) a commitment to securing the data using appropriate computer technology; \& (3) a commitment to destroying or returning the data after analyses are completed.
Publications
Anderson SM, Buckingham BA, Breton MD, Robic JL, Barnett CL, Wakeman CA, Oliveri MC, Brown SA, Ly TT, Clinton PK, Hsu LJ, Kingman RS, Norlander LM, Loebner SE, Reuschel-DiVirglio S, Kovatchev BP. Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia. Diabetes Technol Ther. 2019 Jun;21(6):356-363. doi: 10.1089/dia.2019.0018. Epub 2019 May 16.
PubMed 31095423
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. 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 Hypoglycemia Reduction in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02302963
- Acronym / sponsor ID
- 17725
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 1 (T1DM), Diabetes Assistant (DiAs), Artificial Pancreas (AP) System, Closed-Loop Control (CLC), Unified Safety System (USS) Virginia, Sensor Augmented Pump (SAP), Low Blood Glucose Index (LBGI), Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, TypeZero Technologies, LLC
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Posted 7 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
Detailed description
The purpose of this study is to evaluate the effectiveness of the control system in reducing hypoglycemia by comparing, in a randomized study, 24 hour control with USS Virginia versus sensor augmented pump (SAP) therapy in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia. We will also evaluate the effectiveness of the control system to improve hypoglycemia counterregulation, hypoglycemia awareness, and overall glycemic control. To achieve this goal, we will conduct pre- and post-intervention inpatient assessments of hypoglycemia counterregulation and symptom awareness. Subjects randomized to USS Virginia will participate in two training visits at a monitored outpatient setting for the step-wise deployment of the cell phone based Artificial Pancreas (AP) System at home. The first training visit includes training on the study pump and AP System followed by 1 week use of AP System at home in Pump mode. The second training visit includes additional training on USS Virginia+AP System and confirmation of independent use by the subject followed by 4 week use of the AP System at home in Closed Loop mode. Subjects randomized to sensor-augmented pump therapy will complete 5 weeks of CGM with the home pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP System (DiAs or inControl) with USS Virginia | Experimental | Device: AP System (DiAs or inControl) with USS VirginiaSubject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home. |
| Sensor-Augmented Pump Therapy | Placebo comparator | Device: Sensor-Augmented Pump Therapy (placebo)Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (35 listed)
- Clinical diagnosis of type 1 diabetes for at least 1 year. For an individual to be enrolled at least one criterion from each list must be met:
- Fasting glucose ≥126 mg/dL (confirmed)
- Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL (confirmed)
- HbA1c ≥6.5% (confirmed)
- Random glucose ≥200 mg/dL with symptoms
Key exclusion criteria (26 listed)
- Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment.
- Hematocrit less that the lower limit of normal for the assay.
- Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures; 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.
- Conditions which may increase the risk of induced hypoglycemia such as: known coronary artery disease, congestive heart failure, history of any cardiac arrhythmia (benign premature atrial contractions and premature ventricular contractions allowed), history of seizure disorder, history of cerebrovascular event or transient ischemic attack, hypoglycemia-induced migraine within the last 6 months, or neurological disease.
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 |
|---|---|---|
| AP System (DiAs or inControl) with USS VirginiaSubject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks. | Device | AP System (DiAs or inControl) with USS Virginia |
| Sensor-Augmented Pump Therapy (placebo)Subject will participate in 5 weeks use of CGM and personal insulin pump at home. | Device | Sensor-Augmented Pump Therapy |
Primary outcome
Change in Hypoglycemia During Closed Loop Control (Assessed by Low Blood Glucose Index [LBGI])
Time frame: 2 weeks total: one week of baseline blinded use to compute LBGI-Pre versus use during the last week of intervention to compute LBGI-Post
Change in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention. The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI will be higher for someone with a higher percentage of low blood glucose readings or more extreme hypoglycemic episodes. Reference: Kovatchev BP. Metrics for Glycaemic Control: from HbA1c to Continuous Glucose Monitoring. Nature Reviews Endocrinology 2017; 13: 425-436. PMID: 28304392
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31095423Anderson SM, Buckingham BA, Breton MD, Robic JL, Barnett CL, Wakeman CA, Oliveri MC, Brown SA, Ly TT, Clinton PK, Hsu LJ, Kingman RS, Norlander LM, Loebner SE, Reuschel-DiVirglio S, Kovatchev BP. Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia. Diabetes Technol Ther. 2019 Jun;21(6):356-363. doi: 10.1089/dia.2019.0018. Epub 2019 May 16.
- Individual participant dataSharing planned: Yes. NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, \& exercise will be deidentified \& retrievable only by subject ID number. The data's real value lies in their precise time stamps - each reading is coded by date \& time which makes possible the data to be related to the subjects' daily routine. Individual patterns of demographic \& insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Data can be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes \& not to identify participants; (2) a commitment to securing the data using appropriate computer technology; \& (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Stacey M. Anderson, MD principal investigator
UVA Center for Diabetes Technology
Bruce Buckingham, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by University of Virginia at 2 sites in United States.
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 35 inclusion and 26 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 7 Oct 2022). 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?
Change in Hypoglycemia During Closed Loop Control (Assessed by Low Blood Glucose Index [LBGI]) (time frame: 2 weeks total: one week of baseline blinded use to compute LBGI-Pre versus use during the last week of intervention to compute LBGI-Post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302963, which also lists 1 linked publication.
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 7 Oct 2022.