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DIaMonD: Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Sponsor
DexCom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02282397
Collaborator
Jaeb Center for Health Research (Other)
316
Enrollment
30
Locations
4
Arms
26
Duration (Months)
10.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Continuous Glucose Monitor
 N/A

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 Design

Study Type:
Interventional
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 :
Sep 1, 2014
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

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
Other: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Phase 1 (T1DM) - A1C [6 months]

      Change in A1C from baseline to 24 weeks

    2. Phase 1 (T2DM) - A1C [6 months]

      Change in A1C from baseline to 24 weeks

    3. Phase 2 (T1DM) [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 [6 months]

      % of subjects with A1C less than 7%

    2. Phase 1 (T1DM) - A1C Outcomes [6 months]

      % of subjects with A1C less than 7.5%

    3. Phase 1 (T1DM) - A1C Outcomes [6 months]

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

    4. Phase 1 (T1DM) - A1C Outcomes [6 months]

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

    5. Phase 1 (T1DM) - A1C Outcomes [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 [6 months]

      Mean glucose (overall, daytime, and nighttime separately)

    7. Phase 1 (T1DM) - CGM Outcomes [6 months]

      Glucose variability (overall, daytime, and nighttime separately)

    8. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    9. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    10. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    11. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    12. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    13. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    14. Phase 1 (T1DM) - CGM Outcomes [6 months]

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

    15. Phase 1 (T1DM) - Hypoglycemia Awareness [6 months]

      Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

    16. Phase 1 (T1DM) - SMBG Outcome [6 months]

      Change in SMBG frequency from baseline to 24 weeks

    17. Phase 1 (T1DM) - QoL Outcomes [6 months]

      Quality of life changes from baseline to 24 weeks

    18. Phase 1 (T1DM) - Cost Effectiveness [6 months]

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

    19. Phase 1 (T1DM) - Adverse Events [6 months]

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

    20. Phase 1 (T1DM) - Adverse Events [6 months]

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

    21. Phase 1 (T1DM) - Body Weight [6 months]

      Change in body weight from baseline to 24 weeks

    22. Phase 1 (T1DM) - Insulin Use Outcomes [6 months]

      Change in total daily insulin from baseline to 24 weeks

    23. Phase 1 (T1DM) - Insulin Use Outcomes [6 months]

      Basal to bolus insulin ratio

    24. Phase 1 (T1DM) - Insulin Use Outcomes [6 months]

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

    25. Phase 1 (T2DM) - A1C Outcomes [6 months]

      % of subjects with A1C less than 7%

    26. Phase 1 (T2DM) - A1C Outcomes [6 months]

      % of subjects with A1C less than 7.5%

    27. Phase 1 (T2DM) - A1C Outcomes [6 months]

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

    28. Phase 1 (T2DM) - A1C Outcomes [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 [6 months]

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

    30. Phase 1 (T2DM) - CGM Outcomes [6 months]

      Mean glucose (overall, daytime, and nighttime separately)

    31. Phase 1 (T2DM) - CGM Outcomes [6 months]

      Glucose variability (overall, daytime, and nighttime separately)

    32. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    33. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    34. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    35. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    36. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    37. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    38. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    39. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    40. Phase 1 (T2DM) - CGM Outcomes [6 months]

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

    41. Phase 1 (T2DM) - Hypoglycemia Awareness [6 months]

      Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks

    42. Phase 1 (T2DM) - SMBG [6 months]

      Change in SMBG frequency from baseline to 24 weeks

    43. Phase 1 (T2DM) - QoL Outcomes [6 months]

      Quality of life changes from baseline to 24 weeks

    44. Phase 1 (T2DM) - Cost Effectiveness [6 months]

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

    45. Phase 1 (T2DM) - Adverse Events [6 months]

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

    46. Phase 1 (T2DM) - Adverse Events [6 months]

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

    47. Phase 1 (T2DM) - Body Weight [6 months]

      Change in body weight from baseline to 24 weeks

    48. Phase 1 (T2DM) - Insulin Use Outcomes [6 months]

      Change in total daily insulin from baseline to 24 weeks

    49. Phase 1 (T2DM) - Insulin Use Outcomes [6 months]

      Basal to bolus insulin ratio

    50. Phase 1 (T2DM) - Insulin Use Outcomes [6 months]

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

    51. Phase 2 (T1DM) - A1C Outcomes [6 months]

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

    52. Phase 2 (T1DM) - A1C Outcomes [6 months]

      % of subjects with A1C less than 7%

    53. Phase 2 (T1DM) - A1C Outcomes [6 months]

      % of subjects with A1C less than 7.5%

    54. Phase 2 (T1DM) - A1C Outcomes [6 months]

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

    55. Phase 2 (T1DM) - A1C Outcomes [6 months]

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

    56. Phase 2 (T1DM) - A1C Outcomes [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 [6 months]

      Mean glucose (overall, daytime, and nighttime separately)

    58. Phase 2 (T1DM) - CGM Outcomes [6 months]

      Glucose variability (overall, daytime, and nighttime separately)

    59. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    60. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    61. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    62. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    63. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    64. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    65. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    66. Phase 2 (T1DM) - CGM Outcomes [6 months]

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

    67. Phase 2 (T1DM) - Hypoglycemia Awareness [6 months]

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

    68. Phase 2 (T1DM) - CGM Use [6 months]

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

    69. Phase 2 (T1DM) - SMBG [6 months]

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

    70. Phase 2 (T1DM) - QoL Outcomes [6 months]

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

    71. Phase 2 (T1DM) - Cost Effectiveness [6 months]

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

    72. Phase 2 (T1DM) - Adverse Events [6 months]

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

    73. Phase 2 (T1DM) - Adverse Events [6 months]

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

    74. Phase 2 (T1DM) - Body Weight [6 months]

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

    75. Phase 2 (T1DM) - Insulin Use Outcomes [6 months]

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

    76. Phase 2 (T1DM) - Insulin Use Outcomes [6 months]

      Basal to bolus insulin ratio

    77. Phase 2 (T1DM) - Insulin Use Outcomes [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 [6 months]

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

    2. Phase 1 (T1DM) - Post-Hoc CGM Outcomes [6 months]

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

    3. Phase 1 (T2DM) - Post-Hoc A1C Outcome [6 months]

      % of subjects with a reduction in A1C greater than or equal to 0.5%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marin Endocrine Care & Research Greenbrae California United States 94904
    2 Coastal Metabolic Research Centre Ventura California United States 93003
    3 East Coast Institute for Research, LLC Jacksonville Florida United States 32204
    4 East Coast Institute for Research, LLC Jacksonville Florida United States 32216
    5 Laureate Medical Group at Northside, LLC Atlanta Georgia United States 30308
    6 Atlanta Diabetes Associates Atlanta Georgia United States 30318
    7 Columbus Regional Research Institute Columbus Georgia United States 31904
    8 Physicians Research Associates, LLC Lawrenceville Georgia United States 30046
    9 Endocrine Research Solutions Roswell Georgia United States 30076
    10 Rocky Mountain Diabetes & Osteoporosis Center Idaho Falls Idaho United States 83404
    11 Iowa Diabetes & Endocrinology Research Center Des Moines Iowa United States 50314
    12 Joslin Diabetes Center Boston Massachusetts United States 02215
    13 Henry Ford Health System Detroit Michigan United States 48202
    14 International Diabetes Center Minneapolis Minnesota United States 55416
    15 Washington University in St. Louis Saint Louis Missouri United States 63110
    16 Diabetes & Endocrine Associates, PC Omaha Nebraska United States 68114
    17 Accent Clinical Research Las Vegas Nevada United States 89106
    18 Albany Medical College Albany New York United States 12206
    19 Mountain Diabetes and Endocrine Center Asheville North Carolina United States 28803
    20 Legacy Research Institute Portland Oregon United States 97225
    21 Oregon Health & Science University Portland Oregon United States 97239
    22 Amarillo Medical Specialists, LLP Amarillo Texas United States 79106
    23 Research Institute of Dallas Dallas Texas United States 75231
    24 Diabetes and Glandular Disease San Antonio Texas United States 78229
    25 Consano Clinical Research San Antonio Texas United States 78258
    26 Advanced Research Associates Ogden Utah United States 84405
    27 Granger Medical Clinic Riverton Utah United States 84065
    28 LMC Clinical Research Barrie Ontario Canada L4M 7G1
    29 LMC Clinical Research Thornhill Ontario Canada L4J 8L7
    30 LMC Clinical Research Toronto Ontario Canada M4G 3E8

    Sponsors and Collaborators

    • DexCom, Inc.
    • Jaeb Center for Health Research

    Investigators

    • Study Director: David Price, MD, DexCom, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DexCom, Inc.
    ClinicalTrials.gov Identifier:
    NCT02282397
    Other Study ID Numbers:
    • PTL-901148
    First Posted:
    Nov 4, 2014
    Last Update Posted:
    May 15, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by DexCom, Inc.
    Diabetes Mellitus
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of May 15, 2017