Healthy Subjects Without Type 1 DiabetesPhase 4NCT00717977
Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
A Phase 4 study testing Continuous glucose monitor in people with Healthy Subjects Without Type 1 Diabetes, run by Jaeb Center for Health Research at 10 sites in United States.
Trial summary
The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects Without Type 1 Diabetes
- What is being tested?
- Continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 4
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age > 8 years
- Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects
- No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.
Who cannot join
- History of diabetes or positive islet cell antibody testing
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
University of Colorado
Aurora, Colorado, 80045
Joslin Diabetes Center - Adults
Boston, Massachusetts, 02215
Joslin Diabetes Center - Children
Boston, Massachusetts, 02215
Children's Hospital of Iowa
Iowa City, Iowa, 52242
Nemours Children's Clinic
Jacksonville, Florida, 32207
Yale University School of Medicine
New Haven, Connecticut, 06520
Kaiser Permanente
San Diego, California, 92111
University of Washington
Seattle, Washington, 98105
Stanford University
Stanford, California, 94305
About this study
Official title: A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.
Read the detailed description
- After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
- Subjects will have the following tests performed:
- Hemoglobin A1c (using the DCA2000 or equivalent device)
- Oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels
- Anti-GAD, anti-IA2 and anti-insulin antibodies
- Subjects with an HbA1c >6.0% and/or fasting glucose levels >100 and/or 2 hour glucose levels >140 will be discontinued from the study.
- Subjects with normal A1c and glucose levels will be provided with an RT-CGM and home glucose meter (HGM)
- An RT-CGM sensor will be inserted and initiated by study personnel.
- Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.
- Subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the HGM as needed to calibrate the sensor.
- Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.
- If the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.
- Conditions
- Healthy Subjects Without Type 1 Diabetes
- Being tested
- Continuous glucose monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Also called Abbott FreeStyle Navigator, DexCom SEVEN, Medtronic Guardian Clinical
Daily use of a continuous glucose monitor for 3-7 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Sensor Glucose by Age Group
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.
Measured: 48-72 hours
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.
Measured: 48-72 hours
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.
Measured: 48-72 hours
Peak Daytime Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.
Measured: 48-72 hours
Peak Nightime Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.
Measured: 48-72 hours
Daytime Nadir Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.
Measured: 48-72 hours
Nighttime Nadir Sensor Glucose Value by Age Group
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.
Measured: 48-72 hours
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group
The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.
Measured: 48-72 hours
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day
Measured: 48-72 hours
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group
Measured: 48-72 hours
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day
Measured: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group
Measured: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day
The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.
Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours.
Measured: 48-72 hours
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group
Measured: 48-72 hours
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day
Measured: 48-72 hours
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group
Measured: 48-72 hours
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day
The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.
Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours.
Measured: 48-72 hours
Glucose Variability Measure- Standard Deviation by Age Group
Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.
Measured: 48-72 hours
Glucose Variability Measure- Standard Deviation by Time of Day
Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.
Measured: 48-72 hours
Glucose Variability Measure- Absolute Rate of Change by Age Group
Measured: 48-72 hours
Glucose Variability Measure- Absolute Rate of Change by Time of Day
Measured: 48-72 hours
Glucose Variability Measure- Coefficient of Variation by Age Group
The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.
Measured: 48-72 hours
Glucose Variability Measure- Coefficient of Variation by Time of Day
The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.
Measured: 48-72 hours
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Measured: 48-72 hours
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionMar 2009
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 Healthy Subjects Without 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 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- JDRF Artificial Pancreas Project
- Responsible party
- Sponsor
- Investigators
- Roy W Beck, M.D., Ph.D., Study director, Jaeb Center for Health ResearchLori Laffel, M.D., Study chair, Joslin Diabetes Center Pediatric SectionWilliam Tamborlane, M.D., Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717977
- Sponsor's protocol ID
- 2008-2403
- Status last verified
- Sep 2016
- First submitted
- 16 Jul 2008
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.
PubMed 20215454Shah VN, Vigers T, Pyle L, Calhoun P, Bergenstal RM. Discordance Between Glucose Management Indicator and Glycated Hemoglobin in People Without Diabetes. Diabetes Technol Ther. 2023 May;25(5):324-328. doi: 10.1089/dia.2022.0544. Epub 2023 Mar 3.
PubMed 36790875
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00717977
- Acronym / sponsor ID
- 2008-2403
- Conditions
- Healthy Subjects Without Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- JDRF Artificial Pancreas Project
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 18 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.
Detailed description
- After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
- Subjects will have the following tests performed:
- Hemoglobin A1c (using the DCA2000 or equivalent device)
- Oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels
- Anti-GAD, anti-IA2 and anti-insulin antibodies
- Subjects with an HbA1c >6.0% and/or fasting glucose levels >100 and/or 2 hour glucose levels >140 will be discontinued from the study.
- Subjects with normal A1c and glucose levels will be provided with an RT-CGM and home glucose meter (HGM)
- An RT-CGM sensor will be inserted and initiated by study personnel.
- Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.
- Subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the HGM as needed to calibrate the sensor.
- Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.
- If the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 8 years
- Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects
- No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.
Key exclusion criteria (1 listed)
- History of diabetes or positive islet cell antibody testing
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 |
|---|---|---|
| Continuous glucose monitorAlso: Abbott FreeStyle Navigator, DexCom SEVEN, Medtronic Guardian ClinicalDaily use of a continuous glucose monitor for 3-7 days | Device | – |
Primary outcome
Overall Mean Sensor Glucose by Age Group
Time frame: 48-72 hours
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.
Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group
Time frame: 48-72 hours
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.
Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group
Time frame: 48-72 hours
Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.
Peak Daytime Sensor Glucose Value by Age Group
Time frame: 48-72 hours
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.
Peak Nightime Sensor Glucose Value by Age Group
Time frame: 48-72 hours
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.
Daytime Nadir Sensor Glucose Value by Age Group
Time frame: 48-72 hours
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.
Nighttime Nadir Sensor Glucose Value by Age Group
Time frame: 48-72 hours
The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.
Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group
Time frame: 48-72 hours
The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.
Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day
Time frame: 48-72 hours
Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day
Time frame: 48-72 hours
The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported. Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours.
Percentage of Sensor Glucose Levels >120 mg/dL by Age Group
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels >140 mg/dL by Age Group
Time frame: 48-72 hours
Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day
Time frame: 48-72 hours
The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported. Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours.
Glucose Variability Measure- Standard Deviation by Age Group
Time frame: 48-72 hours
Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.
Glucose Variability Measure- Standard Deviation by Time of Day
Time frame: 48-72 hours
Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.
Glucose Variability Measure- Absolute Rate of Change by Age Group
Time frame: 48-72 hours
Glucose Variability Measure- Absolute Rate of Change by Time of Day
Time frame: 48-72 hours
Glucose Variability Measure- Coefficient of Variation by Age Group
Time frame: 48-72 hours
The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.
Glucose Variability Measure- Coefficient of Variation by Time of Day
Time frame: 48-72 hours
The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.
Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group
Time frame: 48-72 hours
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day
Time frame: 48-72 hours
The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20215454Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.
- Derived from this study: PubMed 36790875Shah VN, Vigers T, Pyle L, Calhoun P, Bergenstal RM. Discordance Between Glucose Management Indicator and Glycated Hemoglobin in People Without Diabetes. Diabetes Technol Ther. 2023 May;25(5):324-328. doi: 10.1089/dia.2022.0544. Epub 2023 Mar 3.
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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 W Beck, M.D., Ph.D. study director
Jaeb Center for Health Research
Lori Laffel, M.D. study chair
Joslin Diabetes Center Pediatric Section
William Tamborlane, M.D. study chair
Yale University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous glucose monitor in people with Healthy Subjects Without Type 1 Diabetes, run by Jaeb Center for Health Research at 10 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 3 inclusion and 1 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Oct 2010). 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?
Overall Mean Sensor Glucose by Age Group (time frame: 48-72 hours). The study lists 25 primary outcomes in all. 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 NCT00717977, 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 19 Oct 2016.