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Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD)

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ClinicalTrials.gov Identifier: NCT02282397
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Jaeb Center for Health Research
Information provided by (Responsible Party):
DexCom, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Continuous Glucose Monitor Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Study Start Date : September 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
No Intervention: Phase 1: SMBG
Type 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered
Phase 1: CGM
Type 1 or Type 2 diabetes mellitus subjects using RT-CGM and SMBG testing for diabetes management. RT-CGM (Continuous Glucose Monitoring) is the intervention.
Device: Continuous Glucose Monitor
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
Other Names:
  • CGM
  • RT-CGM

No Intervention: Phase 2: CGM/MDI
Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management.
No Intervention: Phase 2: CGM/CSII
Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management.



Primary Outcome Measures :
  1. Phase 1 (T1DM) - A1C [ Time Frame: 6 months ]
    Change in A1C from baseline to 24 weeks

  2. Phase 1 (T2DM) - A1C [ Time Frame: 6 months ]
    Change in A1C from baseline to 24 weeks

  3. Phase 2 (T1DM) [ Time Frame: 6 months ]
    Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks


Secondary Outcome Measures :
  1. Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%

  2. Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%

  3. Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%

  4. Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%

  5. Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

  6. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)

  7. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)

  8. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)

  9. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

  10. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

  11. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

  12. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

  13. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

  14. Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

  15. Phase 1 (T1DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

  16. Phase 1 (T1DM) - SMBG Outcome [ Time Frame: 6 months ]
    Change in SMBG frequency from baseline to 24 weeks

  17. Phase 1 (T1DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from baseline to 24 weeks

  18. Phase 1 (T1DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

  19. Phase 1 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of SH events from baseline to 24 weeks

  20. Phase 1 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of DKA events from baseline to 24 weeks

  21. Phase 1 (T1DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from baseline to 24 weeks

  22. Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from baseline to 24 weeks

  23. Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio

  24. Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in the number of boluses/day from baseline to 24 weeks

  25. Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%

  26. Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%

  27. Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%

  28. Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

  29. Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%

  30. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)

  31. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)

  32. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)

  33. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

  34. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

  35. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

  36. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

  37. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

  38. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

  39. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)

  40. Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area under curve 180 mg/dL (overall, daytime, and nighttime separately)

  41. Phase 1 (T2DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

  42. Phase 1 (T2DM) - SMBG [ Time Frame: 6 months ]
    Change in SMBG frequency from baseline to 24 weeks

  43. Phase 1 (T2DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from baseline to 24 weeks

  44. Phase 1 (T2DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

  45. Phase 1 (T2DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of SH Events from baseline to 24 weeks

  46. Phase 1 (T2DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of DKA Events from baseline to 24 weeks

  47. Phase 1 (T2DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from baseline to 24 weeks

  48. Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from baseline to 24 weeks

  49. Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio

  50. Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in the number of boluses/day from baseline to 24 weeks

  51. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    Change in A1C from Phase 2 baseline to Phase 2 28 weeks

  52. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%

  53. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%

  54. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%

  55. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%

  56. Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%

  57. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)

  58. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)

  59. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)

  60. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)

  61. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)

  62. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)

  63. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)

  64. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)

  65. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)

  66. Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 180 mg/dL (overall, daytime, and nighttime separately)

  67. Phase 2 (T1DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks

  68. Phase 2 (T1DM) - CGM Use [ Time Frame: 6 months ]
    Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks

  69. Phase 2 (T1DM) - SMBG [ Time Frame: 6 months ]
    Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks

  70. Phase 2 (T1DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from Phase 2 baseline to Phase 2 28 weeks

  71. Phase 2 (T1DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)

  72. Phase 2 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks

  73. Phase 2 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks

  74. Phase 2 (T1DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from Phase 2 baseline to Phase 2 28 weeks

  75. Phase 2 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks

  76. Phase 2 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio

  77. Phase 2 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks


Other Outcome Measures:
  1. Phase 1 (T1DM) - Post-Hoc CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)

  2. Phase 1 (T1DM) - Post-Hoc CGM Outcomes [ Time Frame: 6 months ]
    Area under curve 180 mg/dL (overall, daytime, and nighttime separately)

  3. Phase 1 (T2DM) - Post-Hoc A1C Outcome [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 0.5%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282397


  Show 30 Study Locations
Sponsors and Collaborators
DexCom, Inc.
Jaeb Center for Health Research
Investigators
Study Director: David Price, MD DexCom, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT02282397     History of Changes
Other Study ID Numbers: PTL-901148
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by DexCom, Inc.:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases