Type 1 DiabetesPHM3NCT02714972
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents
A study testing Hyperglycemia Minimization Algorithm in people with Type 1 Diabetes and Hypoglycemia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data Study Design… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia, Hyperglycemia
- What is being tested?
- Hyperglycemia Minimization Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to May 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- Age 6.0 to <15.0 years
- HbA1c < 10.0%
- Measured with DCA2000 or equivalent device for assessing eligibility
- HbA1c measurements performed as part of usual clinical care within 2 weeks prior to obtaining informed consent for participation in the trial may be used.
- Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
- Living with a family member/guardian ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
- An understanding of and willingness to follow the protocol and sign the informed consent
Who cannot join
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Show all 13Show fewer
- History of ongoing renal disease (other than microalbuminuria). Creatinine level must have been obtained within the last year if subject has diabetes of >10 years duration. If creatinine is > 1.5 mg/dL (132 µmol/L), the subject is excluded.
- Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal disorder
- Abuse of alcohol
- Pregnancy (Negative urine pregnancy test required for females who have experienced menarche as well as agreement from subject and parent/guardian to use a form of contraception to prevent pregnancy while participant is in the study. Subjects who become pregnant will be discontinued from the study)
- Liver disease as defined by an ALT greater than 3 times the upper limit of normal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Stanford University
Stanford, California, 94305
About this study
Official title: Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents (PHM3)
Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data
Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c < 10.0%.
Read more
Sample Size: 30 subjects
Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use
Major Efficacy Outcomes:
- Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
- Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.
Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis
Read the detailed description
Subjects who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite CGM sensor at home for a minimum of 6 days/week over a 2-week period to verify that the subject is able to use the CGM and insert sensors.
The first 10 subjects enrolled will be 11 to <15 years of age and will participate in an Algorithm Assessment Phase of approximately 10 nights of system use each with PLGS and Hyper Minimization active. Results of the approximate 100 nights will be reviewed with the study DSMB to assess safety and determine whether any adjustments to the algorithm parameters are needed. If adjustments are needed, the Algorithm Assessment Phase will be repeated with the same age restriction, using the same 10 subjects if possible. If no adjustments are needed and the DSMB judges it safe to continue the study, enrollment will continue across the full 6 to <15 age range.
Subjects who enroll in the study after the completion of the Algorithm Assessment Phase will use the closed-loop system at home for 5 nights of system use each with PLGS and Hyper Minimization active to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Subjects who successfully demonstrate their ability to use the system at home as described above will be eligible for the randomized trial phase. This phase consists of use of the full system in the home for approximately 42 nights:
- Each night the blood glucose level will be checked with the BG meter and used to perform a calibration of the CGM. This calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Subjects will be instructed to calibrate the CGM per manufacturer guidelines.
- Then the system will be activated, linking the CGM and insulin pump to the computer at the bedside.
- A randomization schedule on the laptop will be used to determine whether the system will run in PLGS+Hyper Minimization mode or PLGS-only.
- Subjects will be blinded as to whether the system is running in PLGS+Hyper Minimization mode or PLGS-only.
- There will not be an alarm if the pump shuts off or if automated insulin dosing occurs. The CGM alarm will be set to 60 mg/dL (3.3 mmol/L). When a CGM alarm occurs, the subject will be asked to measure the blood glucose with a BG meter, if he/she is aware of the alarm.
- The time period for outcome assessment each night will be from the time the system is activated until it is turned off in the morning.
- Pump shut off, when it occurs, will be for up to 120 minutes in a 150-minute period, and no more than 180 minutes for the entire night. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Small correction boluses of insulin will be delivered when the system predicts that hyperglycemia above a pre-set threshold will occur, with insulin-on-board constraints and cumulative delivery limits to minimize the likelihood of excessive insulin delivery.
- Subjects will be asked to check blood glucose with the study BG meter each morning prior to breakfast and enter the results using the controller software interface. The subject will be instructed to contact the study physician if the morning blood glucose value is <60 mg/dl (3.3 mmol/L) or >300 mg/dl (16.7 mmol/L). Monitoring processes will ensure that the subject can be contacted if these values are not reported as required or are out of range.
- Subjects will be asked to record all overnight carbohydrate intake using the controller software interface.
- Subjects will be asked to perform periodic CGM data uploads using the controller software interface. Monitoring processes will ensure that the subject can be contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of hypoglycemia or hyperglycemia, or elevated morning blood glucose values.
Once approximately 200 nights of randomized clinical trial phase data are available, the study DSMB will perform another data review to determine whether it is safe to continue the study. Subjects already using the study system at home will continue to use it during the DSMB review process, but no additional subjects will begin home use of the system until the DSMB review is complete.
Upon completion of the study, subjects as well as study clinicians will be asked to complete a human factors usability questionnaire regarding use of the study system.
There will be a follow-up (optional) extension phase for subjects who exhibit safe and competent use of the system at home. They may be given the option to continue home use of the system for up to 56 days to assess whether data-driven, subject-level customization of algorithm parameters improves glycemic outcomes compared with generic algorithm parameters that are identical for each subject.
- Conditions
- Type 1 Diabetes, Hypoglycemia, Hyperglycemia, Artificial Pancreas
- Being tested
- Hyperglycemia Minimization Algorithm
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycemia Minimization AlgorithmDevice
The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump.
| Study group | Role | What they receive |
|---|---|---|
| Hyperglycemia Minimization Algorithm | Active comparator | The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump. Receives: Device: Hyperglycemia Minimization Algorithm |
| Predictive Low Glucose Suspend | No intervention | The control algorithm will run passively and not dose additional insulin. If hypoglycemia is predicted, the system will suspend the pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Time 70-<180mg/dL Per Night Over 42 Nights
A single percentage calculated for each subject by pooling all CGM readings from the PLSG+HM nights and PLGS-only nights for the same subject. All CGM readings regardless of the amount of data will be weighted equally in the pooled percentage regardless of how they distribute across nights.
Measured: 42 nights
Secondary outcomes (6)
Mean Overnight Sensor Glucose
Measured: Up to 42 nights
Glucose Standard Deviation and Coefficient of Variation
Measured: Up to 42 nights
Percent of Time <50 mg/dl (2.8 mmol/L) Per Night Over 42 Nights
Measured: 42 nights
Percent Time <60 mg/dl (3.3 mmol/L) Per Night Over 42 Nights
Measured: 42 nights
Percent Time <70 mg/dl (3.9 mmol/L) Per Night Over 42 Nights
Measured: 42 nights
Percent Time >180 mg/dl (10.0 mmol/L) Per Night Over 42 Nights
Measured: 42 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMay 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.
- Other trials for Type 1 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce A Buckingham, MD, Study chair, Stanford UniversityJohn W Lum, MS, Study director, Jaeb Center for Health ResearchRoy Beck, MD, PhD, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714972
- Sponsor's protocol ID
- PHM3
- Acronym
- PHM3
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2016
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents (PHM3)
- ClinicalTrials.gov ID
- NCT02714972
- Acronym / sponsor ID
- PHM3 / PHM3
- Conditions
- Type 1 Diabetes, Hypoglycemia, Hyperglycemia, Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data
Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c < 10.0%.
Sample Size: 30 subjects
Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use
Major Efficacy Outcomes:
- Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.
- Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.
Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis
Detailed description
Subjects who are eligible for the clinical trial initially will use a Veo insulin pump and Enlite CGM sensor at home for a minimum of 6 days/week over a 2-week period to verify that the subject is able to use the CGM and insert sensors.
The first 10 subjects enrolled will be 11 to <15 years of age and will participate in an Algorithm Assessment Phase of approximately 10 nights of system use each with PLGS and Hyper Minimization active. Results of the approximate 100 nights will be reviewed with the study DSMB to assess safety and determine whether any adjustments to the algorithm parameters are needed. If adjustments are needed, the Algorithm Assessment Phase will be repeated with the same age restriction, using the same 10 subjects if possible. If no adjustments are needed and the DSMB judges it safe to continue the study, enrollment will continue across the full 6 to <15 age range.
Subjects who enroll in the study after the completion of the Algorithm Assessment Phase will use the closed-loop system at home for 5 nights of system use each with PLGS and Hyper Minimization active to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Subjects who successfully demonstrate their ability to use the system at home as described above will be eligible for the randomized trial phase. This phase consists of use of the full system in the home for approximately 42 nights:
- Each night the blood glucose level will be checked with the BG meter and used to perform a calibration of the CGM. This calibration must occur no more than 90 minutes prior to activation of the system. NOTE: Subjects will be instructed to calibrate the CGM per manufacturer guidelines.
- Then the system will be activated, linking the CGM and insulin pump to the computer at the bedside.
- A randomization schedule on the laptop will be used to determine whether the system will run in PLGS+Hyper Minimization mode or PLGS-only.
- Subjects will be blinded as to whether the system is running in PLGS+Hyper Minimization mode or PLGS-only.
- There will not be an alarm if the pump shuts off or if automated insulin dosing occurs. The CGM alarm will be set to 60 mg/dL (3.3 mmol/L). When a CGM alarm occurs, the subject will be asked to measure the blood glucose with a BG meter, if he/she is aware of the alarm.
- The time period for outcome assessment each night will be from the time the system is activated until it is turned off in the morning.
- Pump shut off, when it occurs, will be for up to 120 minutes in a 150-minute period, and no more than 180 minutes for the entire night. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Small correction boluses of insulin will be delivered when the system predicts that hyperglycemia above a pre-set threshold will occur, with insulin-on-board constraints and cumulative delivery limits to minimize the likelihood of excessive insulin delivery.
- Subjects will be asked to check blood glucose with the study BG meter each morning prior to breakfast and enter the results using the controller software interface. The subject will be instructed to contact the study physician if the morning blood glucose value is <60 mg/dl (3.3 mmol/L) or >300 mg/dl (16.7 mmol/L). Monitoring processes will ensure that the subject can be contacted if these values are not reported as required or are out of range.
- Subjects will be asked to record all overnight carbohydrate intake using the controller software interface.
- Subjects will be asked to perform periodic CGM data uploads using the controller software interface. Monitoring processes will ensure that the subject can be contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of hypoglycemia or hyperglycemia, or elevated morning blood glucose values.
Once approximately 200 nights of randomized clinical trial phase data are available, the study DSMB will perform another data review to determine whether it is safe to continue the study. Subjects already using the study system at home will continue to use it during the DSMB review process, but no additional subjects will begin home use of the system until the DSMB review is complete.
Upon completion of the study, subjects as well as study clinicians will be asked to complete a human factors usability questionnaire regarding use of the study system.
There will be a follow-up (optional) extension phase for subjects who exhibit safe and competent use of the system at home. They may be given the option to continue home use of the system for up to 56 days to assess whether data-driven, subject-level customization of algorithm parameters improves glycemic outcomes compared with generic algorithm parameters that are identical for each subject.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperglycemia Minimization Algorithm | Active comparator | Device: Hyperglycemia Minimization AlgorithmThe hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump. |
| Predictive Low Glucose Suspend | No intervention | –The control algorithm will run passively and not dose additional insulin. If hypoglycemia is predicted, the system will suspend the pump. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- Age 6.0 to <15.0 years
- HbA1c < 10.0%
- Uninterrupted internet access while study system is being used overnight and for upload of study data in the morning
- Living with a family member/guardian ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night
Key exclusion criteria (13 listed)
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- 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 |
|---|---|---|
| Hyperglycemia Minimization AlgorithmThe hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump. | Device | Hyperglycemia Minimization Algorithm |
Primary outcome
Percent Time 70-<180mg/dL Per Night Over 42 Nights
Time frame: 42 nights
A single percentage calculated for each subject by pooling all CGM readings from the PLSG+HM nights and PLGS-only nights for the same subject. All CGM readings regardless of the amount of data will be weighted equally in the pooled percentage regardless of how they distribute across nights.
6 secondary outcomes
Mean Overnight Sensor Glucose
Time frame: Up to 42 nights
Glucose Standard Deviation and Coefficient of Variation
Time frame: Up to 42 nights
Percent of Time <50 mg/dl (2.8 mmol/L) Per Night Over 42 Nights
Time frame: 42 nights
Percent Time <60 mg/dl (3.3 mmol/L) Per Night Over 42 Nights
Time frame: 42 nights
Percent Time <70 mg/dl (3.9 mmol/L) Per Night Over 42 Nights
Time frame: 42 nights
Percent Time >180 mg/dl (10.0 mmol/L) Per Night Over 42 Nights
Time frame: 42 nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 1 Diabetes
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.
Bruce A Buckingham, MD study chair
Stanford University
John W Lum, MS study director
Jaeb Center for Health Research
Roy Beck, MD, PhD principal investigator
Jaeb Center for Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperglycemia Minimization Algorithm in people with Type 1 Diabetes and Hypoglycemia, run by Jaeb Center for Health Research 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 8 inclusion and 13 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 15 Oct 2026. 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. 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 15 Oct 2026). 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?
Percent Time 70-<180mg/dL Per Night Over 42 Nights (time frame: 42 nights). 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 15 Oct 2026.