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AzTrials

Diabetes MellitusDIaMonDNCT02282397

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, run by DexCom, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Continuous Glucose Monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
30 sitesin 2 countries
Study dates
Sep 2014to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

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 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 25 years or older
  • Diagnosis of Type 1 diabetes mellitus or insulin-requiring Type 2 diabetes mellitus
  • Followed regularly by a physician or diabetes educator
  • Using multiple daily injections
  • stable control of diabetes
  • willing to wear a device such as pump or continuous glucose monitor

Who cannot join

  • recent or planned use of non-insulin injectable hypoglycemic agents
  • Pregnancy or planning to become pregnant during the study
  • Medical conditions that make it inappropriate or unsafe to target an A1C of <7%
  • Renal disease with Glomerular Filtration Rate <45
  • Extensive skin changes/disease that precludes wearing the sensor on normal skin
  • Known allergy to medical-grade adhesives
  • Recent hospitalization or emergency room visit in the 6 months prior to screening resulting in primary diagnosis of uncontrolled diabetes

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States27 sites

  • Albany Medical College

    Albany, New York, 12206

  • Amarillo Medical Specialists, LLP

    Amarillo, Texas, 79106

  • Mountain Diabetes and Endocrine Center

    Asheville, North Carolina, 28803

  • Laureate Medical Group at Northside, LLC

    Atlanta, Georgia, 30308

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Iowa Diabetes & Endocrinology Research Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Marin Endocrine Care & Research

    Greenbrae, California, 94904

  • Rocky Mountain Diabetes & Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • Accent Clinical Research

    Las Vegas, Nevada, 89106

  • Physicians Research Associates, LLC

    Lawrenceville, Georgia, 30046

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Advanced Research Associates

    Ogden, Utah, 84405

  • Diabetes & Endocrine Associates, PC

    Omaha, Nebraska, 68114

  • Legacy Research Institute

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Granger Medical Clinic

    Riverton, Utah, 84065

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Diabetes and Glandular Disease

    San Antonio, Texas, 78229

  • Consano Clinical Research

    San Antonio, Texas, 78258

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Coastal Metabolic Research Centre

    Ventura, California, 93003

Other trials in United States

Canada3 sites

  • LMC Clinical Research

    Barrie, Ontario, L4M 7G1

  • LMC Clinical Research

    Thornhill, Ontario, L4J 8L7

  • LMC Clinical Research

    Toronto, Ontario, M4G 3E8

Other trials in Canada

About this study

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

Read the detailed description

The study design includes two cohorts that will be treated separately. Phase 1 will include two diabetes cohorts (Type 1 diabetes mellitus and Type 2 diabetes mellitus) who will be randomized independently into two groups, Group 1-CGM and Group 2-SMBG.

The Group-1 CGM cohort who have Type 1 diabetes mellitus will be eligible for Phase 2. Phase 2 will include a separate independent randomization of either MDI therapy (Group 1a- CGM/MDI) or CSII therapy (Group 1b-CGM/CSII).

Additional assessments will be made to evaluate the incremental benefits of changing the insulin delivery method from MDI to CSII in patients already using CGM.

Cost effectiveness and quality of life will be measured between the two groups in each phase.

Being tested
Continuous Glucose Monitor
Keywords
Diabetes Mellitus
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose MonitorDevice

    Also called CGM, RT-CGM

    RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.

Study groups in NCT02282397
Study groupRoleWhat they receive
Phase 1: SMBGNo interventionType 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered
Phase 1: CGMOtherType 1 or Type 2 diabetes mellitus subjects using RT-CGM and SMBG testing for diabetes management. RT-CGM (Continuous Glucose Monitoring) is the intervention.
Receives: Device: Continuous Glucose Monitor
Phase 2: CGM/MDINo interventionType 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management.
Phase 2: CGM/CSIINo interventionType 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 (T1DM) - A1C

    Change in A1C from baseline to 24 weeks

    Measured: 6 months

  2. Phase 1 (T2DM) - A1C

    Change in A1C from baseline to 24 weeks

    Measured: 6 months

  3. Phase 2 (T1DM)

    Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

Secondary outcomes (77)

  1. Phase 1 (T1DM) - A1C Outcomes

    % of subjects with A1C less than 7%

    Measured: 6 months

  2. Phase 1 (T1DM) - A1C Outcomes

    % of subjects with A1C less than 7.5%

    Measured: 6 months

  3. Phase 1 (T1DM) - A1C Outcomes

    % of subjects with a relative reduction in A1C greater than or equal to 10%

    Measured: 6 months

  4. Phase 1 (T1DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1%

    Measured: 6 months

  5. Phase 1 (T1DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

    Measured: 6 months

  6. Phase 1 (T1DM) - CGM Outcomes

    Mean glucose (overall, daytime, and nighttime separately)

    Measured: 6 months

  7. Phase 1 (T1DM) - CGM Outcomes

    Glucose variability (overall, daytime, and nighttime separately)

    Measured: 6 months

  8. Phase 1 (T1DM) - CGM Outcomes

    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  9. Phase 1 (T1DM) - CGM Outcomes

    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  10. Phase 1 (T1DM) - CGM Outcomes

    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  11. Phase 1 (T1DM) - CGM Outcomes

    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  12. Phase 1 (T1DM) - CGM Outcomes

    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  13. Phase 1 (T1DM) - CGM Outcomes

    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  14. Phase 1 (T1DM) - CGM Outcomes

    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  15. Phase 1 (T1DM) - Hypoglycemia Awareness

    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

    Measured: 6 months

  16. Phase 1 (T1DM) - SMBG Outcome

    Change in SMBG frequency from baseline to 24 weeks

    Measured: 6 months

  17. Phase 1 (T1DM) - QoL Outcomes

    Quality of life changes from baseline to 24 weeks

    Measured: 6 months

  18. Phase 1 (T1DM) - Cost Effectiveness

    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

    Measured: 6 months

  19. Phase 1 (T1DM) - Adverse Events

    Change in the number of SH events from baseline to 24 weeks

    Measured: 6 months

  20. Phase 1 (T1DM) - Adverse Events

    Change in the number of DKA events from baseline to 24 weeks

    Measured: 6 months

  21. Phase 1 (T1DM) - Body Weight

    Change in body weight from baseline to 24 weeks

    Measured: 6 months

  22. Phase 1 (T1DM) - Insulin Use Outcomes

    Change in total daily insulin from baseline to 24 weeks

    Measured: 6 months

  23. Phase 1 (T1DM) - Insulin Use Outcomes

    Basal to bolus insulin ratio

    Measured: 6 months

  24. Phase 1 (T1DM) - Insulin Use Outcomes

    Change in the number of boluses/day from baseline to 24 weeks

    Measured: 6 months

  25. Phase 1 (T2DM) - A1C Outcomes

    % of subjects with A1C less than 7%

    Measured: 6 months

  26. Phase 1 (T2DM) - A1C Outcomes

    % of subjects with A1C less than 7.5%

    Measured: 6 months

  27. Phase 1 (T2DM) - A1C Outcomes

    % of subjects with a relative reduction in A1C greater than or equal to 10%

    Measured: 6 months

  28. Phase 1 (T2DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

    Measured: 6 months

  29. Phase 1 (T2DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1%

    Measured: 6 months

  30. Phase 1 (T2DM) - CGM Outcomes

    Mean glucose (overall, daytime, and nighttime separately)

    Measured: 6 months

  31. Phase 1 (T2DM) - CGM Outcomes

    Glucose variability (overall, daytime, and nighttime separately)

    Measured: 6 months

  32. Phase 1 (T2DM) - CGM Outcomes

    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  33. Phase 1 (T2DM) - CGM Outcomes

    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  34. Phase 1 (T2DM) - CGM Outcomes

    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  35. Phase 1 (T2DM) - CGM Outcomes

    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  36. Phase 1 (T2DM) - CGM Outcomes

    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  37. Phase 1 (T2DM) - CGM Outcomes

    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  38. Phase 1 (T2DM) - CGM Outcomes

    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  39. Phase 1 (T2DM) - CGM Outcomes

    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  40. Phase 1 (T2DM) - CGM Outcomes

    Area under curve 180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  41. Phase 1 (T2DM) - Hypoglycemia Awareness

    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

    Measured: 6 months

  42. Phase 1 (T2DM) - SMBG

    Change in SMBG frequency from baseline to 24 weeks

    Measured: 6 months

  43. Phase 1 (T2DM) - QoL Outcomes

    Quality of life changes from baseline to 24 weeks

    Measured: 6 months

  44. Phase 1 (T2DM) - Cost Effectiveness

    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

    Measured: 6 months

  45. Phase 1 (T2DM) - Adverse Events

    Change in the number of SH Events from baseline to 24 weeks

    Measured: 6 months

  46. Phase 1 (T2DM) - Adverse Events

    Change in the number of DKA Events from baseline to 24 weeks

    Measured: 6 months

  47. Phase 1 (T2DM) - Body Weight

    Change in body weight from baseline to 24 weeks

    Measured: 6 months

  48. Phase 1 (T2DM) - Insulin Use Outcomes

    Change in total daily insulin from baseline to 24 weeks

    Measured: 6 months

  49. Phase 1 (T2DM) - Insulin Use Outcomes

    Basal to bolus insulin ratio

    Measured: 6 months

  50. Phase 1 (T2DM) - Insulin Use Outcomes

    Change in the number of boluses/day from baseline to 24 weeks

    Measured: 6 months

  51. Phase 2 (T1DM) - A1C Outcomes

    Change in A1C from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  52. Phase 2 (T1DM) - A1C Outcomes

    % of subjects with A1C less than 7%

    Measured: 6 months

  53. Phase 2 (T1DM) - A1C Outcomes

    % of subjects with A1C less than 7.5%

    Measured: 6 months

  54. Phase 2 (T1DM) - A1C Outcomes

    % of subjects with a relative reduction in A1C greater than or equal to 10%

    Measured: 6 months

  55. Phase 2 (T1DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1%

    Measured: 6 months

  56. Phase 2 (T1DM) - A1C Outcomes

    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

    Measured: 6 months

  57. Phase 2 (T1DM) - CGM Outcomes

    Mean glucose (overall, daytime, and nighttime separately)

    Measured: 6 months

  58. Phase 2 (T1DM) - CGM Outcomes

    Glucose variability (overall, daytime, and nighttime separately)

    Measured: 6 months

  59. Phase 2 (T1DM) - CGM Outcomes

    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  60. Phase 2 (T1DM) - CGM Outcomes

    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  61. Phase 2 (T1DM) - CGM Outcomes

    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  62. Phase 2 (T1DM) - CGM Outcomes

    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  63. Phase 2 (T1DM) - CGM Outcomes

    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  64. Phase 2 (T1DM) - CGM Outcomes

    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  65. Phase 2 (T1DM) - CGM Outcomes

    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  66. Phase 2 (T1DM) - CGM Outcomes

    Area above curve 180 mg/dL (overall, daytime, and nighttime separately)

    Measured: 6 months

  67. Phase 2 (T1DM) - Hypoglycemia Awareness

    Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  68. Phase 2 (T1DM) - CGM Use

    Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  69. Phase 2 (T1DM) - SMBG

    Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  70. Phase 2 (T1DM) - QoL Outcomes

    Quality of life changes from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  71. Phase 2 (T1DM) - Cost Effectiveness

    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

    Measured: 6 months

  72. Phase 2 (T1DM) - Adverse Events

    Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  73. Phase 2 (T1DM) - Adverse Events

    Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  74. Phase 2 (T1DM) - Body Weight

    Change in body weight from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  75. Phase 2 (T1DM) - Insulin Use Outcomes

    Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

  76. Phase 2 (T1DM) - Insulin Use Outcomes

    Basal to bolus insulin ratio

    Measured: 6 months

  77. Phase 2 (T1DM) - Insulin Use Outcomes

    Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282397
Sponsor's protocol ID
PTL-901148
Acronym
DIaMonD
Status last verified
Feb 2017
First submitted
29 Oct 2014
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.

    PubMed 35604794

  • Puhr S, Welsh JB, Bauza CE, Walker TC. Patients with Type 2 Diabetes and Residual Insulin Secretory Capacity Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring. J Diabetes Sci Technol. 2021 Jul;15(4):965-967. doi: 10.1177/19322968211007880. Epub 2021 Apr 15. No abstract available.

    PubMed 33855888

  • Calhoun P, Price D, Beck RW. Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study. Diabetes Technol Ther. 2021 Mar;23(3):230-233. doi: 10.1089/dia.2020.0471. Epub 2020 Oct 20.

    PubMed 33006904

  • Puhr S, Calhoun P, Welsh JB, Walker TC. The Effect of Reduced Self-Monitored Blood Glucose Testing After Adoption of Continuous Glucose Monitoring on Hemoglobin A1c and Time in Range. Diabetes Technol Ther. 2018 Aug;20(8):557-560. doi: 10.1089/dia.2018.0134. Epub 2018 Jul 23.

    PubMed 30036082

  • Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

    PubMed 28828487

  • Beck RW, Riddlesworth TD, Ruedy KJ, Kollman C, Ahmann AJ, Bergenstal RM, Bhargava A, Bode BW, Haller S, Kruger DF, McGill JB, Polonsky W, Price D, Toschi E; DIAMOND Study Group. Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Sep;5(9):700-708. doi: 10.1016/S2213-8587(17)30217-6. Epub 2017 Jul 12.

    PubMed 28711468

  • Riddlesworth T, Price D, Cohen N, Beck RW. Hypoglycemic Event Frequency and the Effect of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections. Diabetes Ther. 2017 Aug;8(4):947-951. doi: 10.1007/s13300-017-0281-4. Epub 2017 Jun 14.

    PubMed 28616804

  • Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.

    PubMed 28389582

  • Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

    PubMed 28118453

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, run by DexCom, Inc. at 30 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 6 inclusion and 7 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase 1 (T1DM) - A1C (time frame: 6 months). The study lists 3 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 NCT02282397, which also lists 9 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 15 May 2017.

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