Type 1 DiabetesPhase 2NCT01591681
Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
A Phase 2 study testing Pump suspension in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 3 sites in 2 countries.
Trial summary
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pump suspension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2012to Jul 2013
- Phase
- Phase 2
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
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
- Age >/= 15.0 - 45 years
- HbA1c </= 8.0%
- Availability of internet access for periodic upload of study data
Who cannot join
- Diabetic ketoacidosis in the past 3 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 arrhythmiasCoronary artery disease or heart failure
- 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), or liver disease (Creatinine > 1.5 mg/dL (0.08 mmol/L))
- 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
- Liver disease as defined by an ALT greater than 3 times the upper limit of normal
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
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 by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Efficacy Study
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur.
This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training.
Read more
If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include about 45 individuals at 3 clinical centers in the United States and Canada.
Read the detailed description
Patients who are eligible for the clinical trial initially will use a Medtronic Continuous Glucose Monitor (CGM) at home to verify that the subject is able to use the CGM and insert sensors. Subjects already using a Medtronic CGM will skip this phase, provided that the eligibility criteria for CGM use and the study are met.
Patients who meet criteria for sensor use and the study will then use the closed-loop system at home for 5 days to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients 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 as an outpatient for approximately 42 nights:
- Each night the blood glucose level will be checked with the study home blood glucose (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: Patients 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 'pump shut off' application will be active that night or not.
- Patients will be blinded as to whether the pump shut off is active when a session is initiated each night.
- There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL (3.3 mmol/L). When a CGM alarm occurs, the patient 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 2 hours. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Patients will be asked to check blood glucose with the study BG meter, blood ketones with the study ketone meter, and urine ketones with a ketone strip each morning prior to breakfast and enter the results on the study laptop. The patient will be instructed to contact the study physician if the blood glucose or ketone readings are out of an expected range. Patients will be contacted if these morning safety values are not reported as required or are out of range.
- Patients will be asked to record all overnight carbohydrate intake on the study laptop.
- Patients will be asked to perform periodic data uploads using the study laptop. Monitoring processes will ensure that the patient is contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or urine ketone values.
Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.
There will be one follow-up visit after 21 days in the clinical trial and a second follow-up visit after the completion of 42 nights of successful study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.
- Conditions
- Type 1 Diabetes
- Being tested
- Pump suspension
- Keywords
- Type 1 Diabetes, Hypoglycemia, Continuous Glucose Monitoring, Pump Suspension
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pump suspensionDevice
The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
| Study group | Role | What they receive |
|---|---|---|
| Pump suspension algorithm | Active comparator | The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. Receives: Device: Pump suspension |
| Standard of Care | No intervention | The control algorithm will run passively and not recommend control the patient's pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl
Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Secondary outcomes (10)
Percentage of Sensor Glucose Values 71 to 180 mg/dL
The median percentages of the number of glucose values with values of 71-180 mg/dL overall.
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Median Morning Blood Glucose
Measured with a study home blood glucose meter.
Measured: 42 mornings following night of system use
Percent of Mornings With Glucose >250 mg/dL
Measured with a study home blood glucose meter.
Measured: 42 mornings following night of system use
Percent of Mornings With Blood Ketones >1.0 mmol/L
Blood ketones measured with a study blood ketone meter.
Measured: 42 mornings following night of system use
Percent of Mornings With Urine Ketones >/= 15 mg/dl
Urine ketones measured each morning with Ketostix.
Measured: 42 mornings following night of system use
Overall Mean Sensor Glucose Overnight
Calculated as the median of the overall mean.
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Overnight Area Under the Curve 250 mg/dl Per 8 Hour
The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Percent of Nights With Sensor Glucose >250 mg/dL
Measured: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
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 (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy Beck, MD, Ph.D., Principal investigator, Jaeb Center for Health ResearchBruce Buckingham, MD, Study chair, Stanford UniversityJohn Lum, MS, Study director, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591681
- Sponsor's protocol ID
- PSO3
- Other IDs
- 1R01DK085591-01
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2012
- Last updated
- 30 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Maahs DM, Calhoun P, Buckingham BA, Chase HP, Hramiak I, Lum J, Cameron F, Bequette BW, Aye T, Paul T, Slover R, Wadwa RP, Wilson DM, Kollman C, Beck RW; In Home Closed Loop Study Group. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes. Diabetes Care. 2014 Jul;37(7):1885-91. doi: 10.2337/dc13-2159. Epub 2014 May 7.
PubMed 24804697Wilson DM, Calhoun PM, Maahs DM, Chase HP, Messer L, Buckingham BA, Aye T, Clinton PK, Hramiak I, Kollman C, Beck RW; In Home Closed Loop Study Group. Factors associated with nocturnal hypoglycemia in at-risk adolescents and young adults with type 1 diabetes. Diabetes Technol Ther. 2015 Jun;17(6):385-91. doi: 10.1089/dia.2014.0342. Epub 2015 Mar 11.
PubMed 25761202
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Efficacy Study
- ClinicalTrials.gov ID
- NCT01591681
- Acronym / sponsor ID
- PSO3
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Hypoglycemia, Continuous Glucose Monitoring, Pump Suspension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 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
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 5 Jun 2014
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 see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur.
This study has several phases and will take about 3 months for a patient to complete. Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure that they are able and willing to use this system and to determine if they meet the investigators study criteria to proceed with the next phase of the study. Patients will be provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to complete the CGM run-in phase will have an extra office visit for training.
If eligible to continue in the study, patients will need to use the study system for 5 nights at home so that the investigators can make sure they are able to use it correctly. After that, patients will be asked to use the study system each night for an additional 6 to 8 weeks. If the system is active and predicts that a patient's blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include about 45 individuals at 3 clinical centers in the United States and Canada.
Detailed description
Patients who are eligible for the clinical trial initially will use a Medtronic Continuous Glucose Monitor (CGM) at home to verify that the subject is able to use the CGM and insert sensors. Subjects already using a Medtronic CGM will skip this phase, provided that the eligibility criteria for CGM use and the study are met.
Patients who meet criteria for sensor use and the study will then use the closed-loop system at home for 5 days to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients 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 as an outpatient for approximately 42 nights:
- Each night the blood glucose level will be checked with the study home blood glucose (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: Patients 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 'pump shut off' application will be active that night or not.
- Patients will be blinded as to whether the pump shut off is active when a session is initiated each night.
- There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL (3.3 mmol/L). When a CGM alarm occurs, the patient 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 2 hours. Multiple instances of pump suspension can occur if there are recurrent predictions of hypoglycemia during the night.
- Patients will be asked to check blood glucose with the study BG meter, blood ketones with the study ketone meter, and urine ketones with a ketone strip each morning prior to breakfast and enter the results on the study laptop. The patient will be instructed to contact the study physician if the blood glucose or ketone readings are out of an expected range. Patients will be contacted if these morning safety values are not reported as required or are out of range.
- Patients will be asked to record all overnight carbohydrate intake on the study laptop.
- Patients will be asked to perform periodic data uploads using the study laptop. Monitoring processes will ensure that the patient is contacted if these uploads do not occur as required, or if review of an upload reveals any extreme, prolonged episodes of low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or urine ketone values.
Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.
There will be one follow-up visit after 21 days in the clinical trial and a second follow-up visit after the completion of 42 nights of successful study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pump suspension algorithm | Active comparator | Device: Pump suspensionThe study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. |
| Standard of Care | No intervention | –The control algorithm will run passively and not recommend control the patient's pump. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 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
- Age >/= 15.0 - 45 years
- HbA1c </= 8.0%
- Availability of internet access for periodic upload of study data
Key exclusion criteria (13 listed)
- Diabetic ketoacidosis in the past 3 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 arrhythmiasCoronary artery disease or heart failure
- 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 |
|---|---|---|
| Pump suspensionThe study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend. | Device | Pump suspension algorithm |
Primary outcome
Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.
10 secondary outcomes
Percentage of Sensor Glucose Values 71 to 180 mg/dL
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Median Morning Blood Glucose
Time frame: 42 mornings following night of system use
Percent of Mornings With Glucose >250 mg/dL
Time frame: 42 mornings following night of system use
Percent of Mornings With Blood Ketones >1.0 mmol/L
Time frame: 42 mornings following night of system use
Percent of Mornings With Urine Ketones >/= 15 mg/dl
Time frame: 42 mornings following night of system use
Overall Mean Sensor Glucose Overnight
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Overnight Area Under the Curve 250 mg/dl Per 8 Hour
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Percent of Nights With Sensor Glucose >250 mg/dL
Time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24804697Maahs DM, Calhoun P, Buckingham BA, Chase HP, Hramiak I, Lum J, Cameron F, Bequette BW, Aye T, Paul T, Slover R, Wadwa RP, Wilson DM, Kollman C, Beck RW; In Home Closed Loop Study Group. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes. Diabetes Care. 2014 Jul;37(7):1885-91. doi: 10.2337/dc13-2159. Epub 2014 May 7.
- Derived from this study: PubMed 25761202Wilson DM, Calhoun PM, Maahs DM, Chase HP, Messer L, Buckingham BA, Aye T, Clinton PK, Hramiak I, Kollman C, Beck RW; In Home Closed Loop Study Group. Factors associated with nocturnal hypoglycemia in at-risk adolescents and young adults with type 1 diabetes. Diabetes Technol Ther. 2015 Jun;17(6):385-91. doi: 10.1089/dia.2014.0342. Epub 2015 Mar 11.
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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.
Roy Beck, MD, Ph.D. principal investigator
Jaeb Center for Health Research
Bruce Buckingham, MD study chair
Stanford University
John Lum, MS study director
Jaeb Center for Health Research
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pump suspension in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 3 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 4 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2014). 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?
Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl (time frame: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use). 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 NCT01591681, which also lists 2 linked publications.
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 30 Aug 2016.