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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Jaeb Center for Health Research

Information provided by (Responsible Party):

DexCom, Inc.

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
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 Design

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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

U.S. FDA Resources

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
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 :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

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%

Eligibility Criteria

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.

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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

Contacts and Locations

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

Locations

Show 30 study locations

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

Sponsors and Collaborators

DexCom, Inc.

Jaeb Center for Health Research

Investigators

Layout table for investigator information

Study Director:	David Price, MD	DexCom, Inc.

More Information

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

Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.

Puhr S, Welsh JB, Bauza CE, Walker TC. Patients with Type 2 Diabetes and Residual Insulin Secretory Capacity Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring. J Diabetes Sci Technol. 2021 Jul;15(4):965-967. doi: 10.1177/19322968211007880. Epub 2021 Apr 15. No abstract available.

Calhoun P, Price D, Beck RW. Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study. Diabetes Technol Ther. 2021 Mar;23(3):230-233. doi: 10.1089/dia.2020.0471. Epub 2020 Oct 20.

Puhr S, Calhoun P, Welsh JB, Walker TC. The Effect of Reduced Self-Monitored Blood Glucose Testing After Adoption of Continuous Glucose Monitoring on Hemoglobin A1c and Time in Range. Diabetes Technol Ther. 2018 Aug;20(8):557-560. doi: 10.1089/dia.2018.0134. Epub 2018 Jul 23.

Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

Beck RW, Riddlesworth TD, Ruedy KJ, Kollman C, Ahmann AJ, Bergenstal RM, Bhargava A, Bode BW, Haller S, Kruger DF, McGill JB, Polonsky W, Price D, Toschi E; DIAMOND Study Group. Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Sep;5(9):700-708. doi: 10.1016/S2213-8587(17)30217-6. Epub 2017 Jul 12.

Riddlesworth T, Price D, Cohen N, Beck RW. Hypoglycemic Event Frequency and the Effect of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections. Diabetes Ther. 2017 Aug;8(4):947-951. doi: 10.1007/s13300-017-0281-4. Epub 2017 Jun 14.

Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.

Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

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Responsible Party:	DexCom, Inc.
ClinicalTrials.gov Identifier:	NCT02282397
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:

Layout table for MeSH terms

Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

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