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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • Phase 1 (T1DM) - A1C [ Time Frame: 6 months ]
    Change in A1C from baseline to 24 weeks
  • Phase 1 (T2DM) - A1C [ Time Frame: 6 months ]
    Change in A1C from baseline to 24 weeks
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
A1C change at 6 months [ Time Frame: 6 months ]
Percent change in A1C (%) from baseline to 6 month
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%
  • Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%
  • Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%
  • Phase 1 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%
  • 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%
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
  • Phase 1 (T1DM) - SMBG Outcome [ Time Frame: 6 months ]
    Change in SMBG frequency from baseline to 24 weeks
  • Phase 1 (T1DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from baseline to 24 weeks
  • Phase 1 (T1DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
  • Phase 1 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of SH events from baseline to 24 weeks
  • Phase 1 (T1DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of DKA events from baseline to 24 weeks
  • Phase 1 (T1DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from baseline to 24 weeks
  • Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from baseline to 24 weeks
  • Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio
  • Phase 1 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in the number of boluses/day from baseline to 24 weeks
  • Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%
  • Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%
  • Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%
  • 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%
  • Phase 1 (T2DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time in range 70-180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T2DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
  • Phase 1 (T2DM) - SMBG [ Time Frame: 6 months ]
    Change in SMBG frequency from baseline to 24 weeks
  • Phase 1 (T2DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from baseline to 24 weeks
  • Phase 1 (T2DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
  • Phase 1 (T2DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of SH Events from baseline to 24 weeks
  • Phase 1 (T2DM) - Adverse Events [ Time Frame: 6 months ]
    Change in the number of DKA Events from baseline to 24 weeks
  • Phase 1 (T2DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from baseline to 24 weeks
  • Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from baseline to 24 weeks
  • Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio
  • Phase 1 (T2DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in the number of boluses/day from baseline to 24 weeks
  • Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    Change in A1C from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7%
  • Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with A1C less than 7.5%
  • Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a relative reduction in A1C greater than or equal to 10%
  • Phase 2 (T1DM) - A1C Outcomes [ Time Frame: 6 months ]
    % of subjects with a reduction in A1C greater than or equal to 1%
  • 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%
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Mean glucose (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Glucose variability (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 60 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time less than 50 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 250 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    % time greater than 300 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 180 mg/dL (overall, daytime, and nighttime separately)
  • Phase 2 (T1DM) - Hypoglycemia Awareness [ Time Frame: 6 months ]
    Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - CGM Use [ Time Frame: 6 months ]
    Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - SMBG [ Time Frame: 6 months ]
    Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - QoL Outcomes [ Time Frame: 6 months ]
    Quality of life changes from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - Cost Effectiveness [ Time Frame: 6 months ]
    Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
  • 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
  • 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
  • Phase 2 (T1DM) - Body Weight [ Time Frame: 6 months ]
    Change in body weight from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks
  • Phase 2 (T1DM) - Insulin Use Outcomes [ Time Frame: 6 months ]
    Basal to bolus insulin ratio
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
  • Subject at A1C goals [ Time Frame: 6 months ]
    Percent of subjects achieving A1C less than or equal to 7%
  • A1C change at 12 month [ Time Frame: 6 months ]
    Percent change from baseline to 12 months (%)
  • QoL-PROs [ Time Frame: 12 months ]
    Quality of Life Score change from baseline to 6 and 12 months
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2017)
  • Phase 1 (T1DM) - Post-Hoc CGM Outcomes [ Time Frame: 6 months ]
    Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
  • Phase 1 (T1DM) - Post-Hoc CGM Outcomes [ Time Frame: 6 months ]
    Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
  • 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%
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Official Title  ICMJE Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Continuous Glucose Monitor
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
316
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2014)
338
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282397
Other Study ID Numbers  ICMJE PTL-901148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DexCom, Inc.
Study Sponsor  ICMJE DexCom, Inc.
Collaborators  ICMJE Jaeb Center for Health Research
Investigators  ICMJE
Study Director: David Price, MD DexCom, Inc.
PRS Account DexCom, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP