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

May 11, 2017 updated by: DexCom, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 (T1DM) - A1C
Time Frame: 6 months
Change in A1C from baseline to 24 weeks
6 months
Phase 1 (T2DM) - A1C
Time Frame: 6 months
Change in A1C from baseline to 24 weeks
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7%
6 months
Phase 1 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7.5%
6 months
Phase 1 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a relative reduction in A1C greater than or equal to 10%
6 months
Phase 1 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a reduction in A1C greater than or equal to 1%
6 months
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 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
Mean glucose (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
Glucose variability (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time in range 70-180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 60 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 50 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 250 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 300 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - Hypoglycemia Awareness
Time Frame: 6 months
Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
6 months
Phase 1 (T1DM) - SMBG Outcome
Time Frame: 6 months
Change in SMBG frequency from baseline to 24 weeks
6 months
Phase 1 (T1DM) - QoL Outcomes
Time Frame: 6 months
Quality of life changes from baseline to 24 weeks
6 months
Phase 1 (T1DM) - Cost Effectiveness
Time Frame: 6 months
Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
6 months
Phase 1 (T1DM) - Adverse Events
Time Frame: 6 months
Change in the number of SH events from baseline to 24 weeks
6 months
Phase 1 (T1DM) - Adverse Events
Time Frame: 6 months
Change in the number of DKA events from baseline to 24 weeks
6 months
Phase 1 (T1DM) - Body Weight
Time Frame: 6 months
Change in body weight from baseline to 24 weeks
6 months
Phase 1 (T1DM) - Insulin Use Outcomes
Time Frame: 6 months
Change in total daily insulin from baseline to 24 weeks
6 months
Phase 1 (T1DM) - Insulin Use Outcomes
Time Frame: 6 months
Basal to bolus insulin ratio
6 months
Phase 1 (T1DM) - Insulin Use Outcomes
Time Frame: 6 months
Change in the number of boluses/day from baseline to 24 weeks
6 months
Phase 1 (T2DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7%
6 months
Phase 1 (T2DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7.5%
6 months
Phase 1 (T2DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a relative reduction in A1C greater than or equal to 10%
6 months
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%
6 months
Phase 1 (T2DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a reduction in A1C greater than or equal to 1%
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
Mean glucose (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
Glucose variability (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time in range 70-180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time less than 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time less than 60 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time less than 50 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 250 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 300 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - CGM Outcomes
Time Frame: 6 months
Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T2DM) - Hypoglycemia Awareness
Time Frame: 6 months
Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
6 months
Phase 1 (T2DM) - SMBG
Time Frame: 6 months
Change in SMBG frequency from baseline to 24 weeks
6 months
Phase 1 (T2DM) - QoL Outcomes
Time Frame: 6 months
Quality of life changes from baseline to 24 weeks
6 months
Phase 1 (T2DM) - Cost Effectiveness
Time Frame: 6 months
Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
6 months
Phase 1 (T2DM) - Adverse Events
Time Frame: 6 months
Change in the number of SH Events from baseline to 24 weeks
6 months
Phase 1 (T2DM) - Adverse Events
Time Frame: 6 months
Change in the number of DKA Events from baseline to 24 weeks
6 months
Phase 1 (T2DM) - Body Weight
Time Frame: 6 months
Change in body weight from baseline to 24 weeks
6 months
Phase 1 (T2DM) - Insulin Use Outcomes
Time Frame: 6 months
Change in total daily insulin from baseline to 24 weeks
6 months
Phase 1 (T2DM) - Insulin Use Outcomes
Time Frame: 6 months
Basal to bolus insulin ratio
6 months
Phase 1 (T2DM) - Insulin Use Outcomes
Time Frame: 6 months
Change in the number of boluses/day from baseline to 24 weeks
6 months
Phase 2 (T1DM) - A1C Outcomes
Time Frame: 6 months
Change in A1C from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7%
6 months
Phase 2 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with A1C less than 7.5%
6 months
Phase 2 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a relative reduction in A1C greater than or equal to 10%
6 months
Phase 2 (T1DM) - A1C Outcomes
Time Frame: 6 months
% of subjects with a reduction in A1C greater than or equal to 1%
6 months
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%
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
Mean glucose (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
Glucose variability (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 60 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time less than 50 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 250 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
% time greater than 300 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - CGM Outcomes
Time Frame: 6 months
Area above curve 180 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 2 (T1DM) - Hypoglycemia Awareness
Time Frame: 6 months
Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - CGM Use
Time Frame: 6 months
Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - SMBG
Time Frame: 6 months
Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - QoL Outcomes
Time Frame: 6 months
Quality of life changes from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - Cost Effectiveness
Time Frame: 6 months
Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
6 months
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
6 months
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
6 months
Phase 2 (T1DM) - Body Weight
Time Frame: 6 months
Change in body weight from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - Insulin Use Outcomes
Time Frame: 6 months
Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks
6 months
Phase 2 (T1DM) - Insulin Use Outcomes
Time Frame: 6 months
Basal to bolus insulin ratio
6 months
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
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 (T1DM) - Post-Hoc CGM Outcomes
Time Frame: 6 months
Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
6 months
Phase 1 (T1DM) - Post-Hoc CGM Outcomes
Time Frame: 6 months
Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
6 months
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%
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PTL-901148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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