Skip to main content
OpenTrials
Completed

NCT Number: NCT02282397

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LMC Clinical Research, Barrie, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor

Device

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

Other names: CGM, RT-CGM

Primary outcomes

  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 outcomes

  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 outcomes

  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%

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Acronym: DIaMonD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2014
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.