Type 1 Diabetes MellitusNCT01939834
Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes
A study testing Overnight CLC and Sensor-Augmented Pump Therapy (SAP) in people with Type 1 Diabetes Mellitus, run by Sue Brown at 1 site in United States.
Trial summary
The purpose of this study is to use an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for 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 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Overnight CLC and Sensor-Augmented Pump Therapy (SAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥21 and <65 years old.
- Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
- o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test glucose ≥200 mg/dL - confirmed iii. Hemoglobin A1C (HbA1c) ≥6.5% documented - confirmed 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
- o 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
- Use of an insulin pump to treat his/her diabetes for at least 1 year.
- Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
Show all 12Show fewer
- HbA1c <9% as measured with DCA2000 or equivalent device.
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females).
- Demonstration of proper mental status and cognition for the study.
- Willingness to avoid consumption of acetaminophen-containing products 24 hours prior to and during CGM use.
- Ability to access the Internet and upload CGM data via the company software during the data collection period.
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study.
Who cannot join
- Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
- Pregnancy; breast feeding, or intention of becoming pregnant.
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Conditions which may increase the risks associated with possible hypoglycemia, such as any active cardiac disorder/arrhythmia, uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, uncontrolled adrenal insufficiency, neurologic disease or atrial fibrillation.
- Self-reported hypoglycemia unawareness.
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans.
Show all 34Show fewer
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the Continuous Glucose Monitor (CGM) (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants).
- Anticoagulant therapy other than aspirin.
- Oral steroids.
- Subjects currently taking Amylin.
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study sessions.
- Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment).
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Known current or recent alcohol or drug abuse.
- Medical conditions that would make operating a CGM, the Diabetes Assistant (DiAs) cell phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility).
- Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, and cellulitis).
- In adherence with the One Touch Ultra 2 User Guide that may be used in the experimental session and overnight during substudy, subjects with hematocrit levels less than 30% and above 55% will be excluded.
- Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase
- ≥three times the upper reference limit.
- Impaired renal function measured as creatinine >1.2 times above the upper limit of normal.
- Uncontrolled microvascular (diabetic) complications, such as current proliferative diabetic retinopathy or macular edema, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment.
- Active gastroparesis requiring current medical therapy.
- 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.
- Known bleeding diathesis or dyscrasia.
- Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor.
- Active enrollment in another treatment clinical trial. Observational trials may be permitted at the discretion of the study physician.
- Use of anti-diabetic agents other than continuous subcutaneous insulin infusion (CSII) including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, Dipeptidyl peptidase-4 inhibitors, glucagon- like peptide 1 agonists, and alpha-glucosidase inhibitors
- Unwillingness to use an approved form of birth control during this study by a sexually active female participant.
- Subjects with basal rates less than 0.01U/hr.
- RESTRICTIONS ON USE OF OTHER DRUGS OR TREATMENTS
- Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, Dipeptidyl peptidase-4 inhibitors, glucagon- like peptide 1 agonists, and alpha-glucosidase inhibitors.
- Acetaminophen will be restricted starting 24 hours prior to CGM use.
- Medications that block symptoms of hypoglycemia, including but not limited to beta blockers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
The purpose of this study is to use an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for 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. A component of this study evaluated AAA or CLC Control overnight only in 5 consecutive overnights in a cross-over trial with sensor-augmented pump therapy occurring prior to or following CLC overnight. Another component of this study planned evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial this part of the trial was not conducted due to a preference for overnight only configuration in pilot testing. This protocol represents a culmination of prior clinical trials in development of this AAA system and benefits from the synthesis of those components.
Read the detailed description
The primary goal of this study is to test an Advisory/Automated Adaptive (AAA) or CLC Control system, which includes three interacting control modules:
- Module 1 - Automated Safety Supervision (SSM) responsible for prevention of hypoglycemia, which can be adapted (individualized) with prior data for each subject;
- Module 2 - Advisory Module (AM) responsible for pre-meal boluses and postprandial corrections, which can be adapted (individualized) with prior data for each subject;
- Module 3 -- Automated Basal Rate Module (BRM) responsible for augmentation of basal rate to compensate for changes in insulin sensitivity, particularly overnight (e.g. dawn phenomenon), which can be adapted with prior data for each subject.
Daytime control (40hour studies) includes all 3 modules (n=36 were not recruited). Overnight only closed loop control (5 consecutive overnights) includes Module 1 and 3 (n=5-7).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Overnight CLC, Sensor-Augmented Pump Therapy (SAP)
- Keywords
- Type 1 Diabetes Mellitus, Artificial Pancreas, Diabetes Assistant (DiAs), Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight CLCDevice
Overnight Closed-Loop Control (CLC) is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the CLC and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range.
Sensor-Augmented Pump Therapy (SAP)Device
The subject will be on their home insulin pump (UVA) or study pump (Italy) and using a CGM per their usual care.
| Study group | Role | What they receive |
|---|---|---|
| Overnight CLC followed by SAP | Experimental | Throughout the trial, participants wore a study CGM. Participants spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. The participants then subsequently had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal. Receives: Device: Overnight CLC; Device: Sensor-Augmented Pump Therapy (SAP) |
| SAP followed by Overnight CLC | Experimental | Throughout the trial, participants wore a study CGM. Participants in this arm spent a week had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). They subsequently spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal. Receives: Device: Overnight CLC; Device: Sensor-Augmented Pump Therapy (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range Overnight
For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.
Measured: 5 consecutive nights
Secondary outcomes (2)
Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index
A secondary goal of the cross-over trial is to evaluate the ability of the CLC to prevent hypoglycemia with the outcome measure of Low Blood Glucose Index. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk (there is no maximum score). Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale. The calculation of LBGI uses all available CGM values during the 5 consecutive nights of study to create one index. For the SAP group, the mean value lies outside the interquartile range due to outlying values that contribute to increasing the mean.
Measured: 5 consecutive nights
Time Within Target Range
Closed loop control will improve the time spent within the target range of 70-180 mg/dl (computed from retrofitted CGM data).
Measured: 5 consecutive nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Subjects preferred the 5 night overnight system in terms of ease of use.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sue Brown
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., Roche Diagnostics GmbH
- Responsible party
- Sponsor-investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939834
- Sponsor's protocol ID
- 16930
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2013
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brown SA, Kovatchev BP, Breton MD, Anderson SM, Keith-Hynes P, Patek SD, Jiang B, Ben Brahim N, Vereshchetin P, Bruttomesso D, Avogaro A, Del Favero S, Boscari F, Galasso S, Visentin R, Monaro M, Cobelli C. Multinight "bedside" closed-loop control for patients with type 1 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):203-9. doi: 10.1089/dia.2014.0259. Epub 2015 Jan 16.
PubMed 25594434
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01939834
- Acronym / sponsor ID
- 16930
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Artificial Pancreas, Diabetes Assistant (DiAs), Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subjects preferred the 5 night overnight system in terms of ease of use.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sue BrownUniversity, hospital or other
- Collaborators
- DexCom, Inc., Roche Diagnostics GmbH
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 21 May 2024
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 an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for 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. A component of this study evaluated AAA or CLC Control overnight only in 5 consecutive overnights in a cross-over trial with sensor-augmented pump therapy occurring prior to or following CLC overnight. Another component of this study planned evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial this part of the trial was not conducted due to a preference for overnight only configuration in pilot testing. This protocol represents a culmination of prior clinical trials in development of this AAA system and benefits from the synthesis of those components.
Detailed description
The primary goal of this study is to test an Advisory/Automated Adaptive (AAA) or CLC Control system, which includes three interacting control modules:
- Module 1 - Automated Safety Supervision (SSM) responsible for prevention of hypoglycemia, which can be adapted (individualized) with prior data for each subject;
- Module 2 - Advisory Module (AM) responsible for pre-meal boluses and postprandial corrections, which can be adapted (individualized) with prior data for each subject;
- Module 3 -- Automated Basal Rate Module (BRM) responsible for augmentation of basal rate to compensate for changes in insulin sensitivity, particularly overnight (e.g. dawn phenomenon), which can be adapted with prior data for each subject.
Daytime control (40hour studies) includes all 3 modules (n=36 were not recruited). Overnight only closed loop control (5 consecutive overnights) includes Module 1 and 3 (n=5-7).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overnight CLC followed by SAP | Experimental | Device: Overnight CLC, Device: Sensor-Augmented Pump Therapy (SAP)Throughout the trial, participants wore a study CGM. Participants spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. The participants then subsequently had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal. |
| SAP followed by Overnight CLC | Experimental | Device: Overnight CLC, Device: Sensor-Augmented Pump Therapy (SAP)Throughout the trial, participants wore a study CGM. Participants in this arm spent a week had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). They subsequently spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- ≥21 and <65 years old.
- Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
- o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test glucose ≥200 mg/dL - confirmed iii. Hemoglobin A1C (HbA1c) ≥6.5% documented - confirmed 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
- o 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
- Use of an insulin pump to treat his/her diabetes for at least 1 year.
Key exclusion criteria (34 listed)
- Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
- Pregnancy; breast feeding, or intention of becoming pregnant.
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Conditions which may increase the risks associated with possible hypoglycemia, such as any active cardiac disorder/arrhythmia, uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, uncontrolled adrenal insufficiency, neurologic disease or atrial fibrillation.
- Self-reported hypoglycemia unawareness.
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 |
|---|---|---|
| Overnight CLCOvernight Closed-Loop Control (CLC) is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the CLC and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range. | Device | Overnight CLC followed by SAP, SAP followed by Overnight CLC |
| Sensor-Augmented Pump Therapy (SAP)The subject will be on their home insulin pump (UVA) or study pump (Italy) and using a CGM per their usual care. | Device | Overnight CLC followed by SAP, SAP followed by Overnight CLC |
Primary outcome
Time in Range Overnight
Time frame: 5 consecutive nights
For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.
2 secondary outcomes
Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index
Time frame: 5 consecutive nights
Time Within Target Range
Time frame: 5 consecutive nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25594434Brown SA, Kovatchev BP, Breton MD, Anderson SM, Keith-Hynes P, Patek SD, Jiang B, Ben Brahim N, Vereshchetin P, Bruttomesso D, Avogaro A, Del Favero S, Boscari F, Galasso S, Visentin R, Monaro M, Cobelli C. Multinight "bedside" closed-loop control for patients with type 1 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):203-9. doi: 10.1089/dia.2014.0259. Epub 2015 Jan 16.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight CLC and Sensor-Augmented Pump Therapy (SAP) in people with Type 1 Diabetes Mellitus, run by Sue Brown at 1 site 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 12 inclusion and 34 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: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 21 May 2024). 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?
Time in Range Overnight (time frame: 5 consecutive nights). 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 NCT01939834, 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 15 Jun 2026.