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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: SMBG | No Intervention | 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 | Other | 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. |
|
| Phase 2: CGM/MDI | No Intervention | Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management. | |
| Phase 2: CGM/CSII | No Intervention | Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (T1DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months |
| Phase 2 (T1DM) | Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (T1DM) - Post-Hoc CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - Post-Hoc CGM Outcomes | Area under curve 180 mg/dL (overall, daytime, and nighttime separately) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Price, MD | DexCom, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marin Endocrine Care & Research | Greenbrae | California | 94904 | United States | ||
| Coastal Metabolic Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35604794 | Derived | 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. | |
| 33855888 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2019 | |
| Reset | Aug 14, 2019 |
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| 6 months |
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
| Phase 1 (T1DM) - A1C Outcomes | % 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 | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - SMBG Outcome | Change in SMBG frequency from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
| Phase 1 (T1DM) - Adverse Events | Change in the number of SH events from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - Adverse Events | Change in the number of DKA events from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months |
| Phase 1 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
| Phase 1 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months |
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
| Phase 1 (T2DM) - A1C Outcomes | % 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 | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - CGM Outcomes | Area under curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 1 (T2DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - SMBG | Change in SMBG frequency from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
| Phase 1 (T2DM) - Adverse Events | Change in the number of SH Events from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - Adverse Events | Change in the number of DKA Events from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months |
| Phase 1 (T2DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
| Phase 1 (T2DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | Change in A1C from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
| Phase 2 (T1DM) - A1C Outcomes | % 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 | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - CGM Outcomes | Area above curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
| Phase 2 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - CGM Use | Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - SMBG | Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - QoL Outcomes | Quality of life changes from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
| Phase 2 (T1DM) - Adverse Events | Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - Adverse Events | Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - Body Weight | Change in body weight from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| Phase 2 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
| Phase 2 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| 6 months |
| Phase 1 (T2DM) - Post-Hoc A1C Outcome | % of subjects with a reduction in A1C greater than or equal to 0.5% | 6 months |
| Ventura |
| California |
| 93003 |
| United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| Laureate Medical Group at Northside, LLC | Atlanta | Georgia | 30308 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Physicians Research Associates, LLC | Lawrenceville | Georgia | 30046 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| Rocky Mountain Diabetes & Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes & Endocrinology Research Center | Des Moines | Iowa | 50314 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Diabetes & Endocrine Associates, PC | Omaha | Nebraska | 68114 | United States |
| Accent Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Albany Medical College | Albany | New York | 12206 | United States |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | United States |
| Legacy Research Institute | Portland | Oregon | 97225 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Amarillo Medical Specialists, LLP | Amarillo | Texas | 79106 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Diabetes and Glandular Disease | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research | San Antonio | Texas | 78258 | United States |
| Advanced Research Associates | Ogden | Utah | 84405 | United States |
| Granger Medical Clinic | Riverton | Utah | 84065 | United States |
| LMC Clinical Research | Barrie | Ontario | L4M 7G1 | Canada |
| LMC Clinical Research | Thornhill | Ontario | L4J 8L7 | Canada |
| LMC Clinical Research | Toronto | Ontario | M4G 3E8 | Canada |
| 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. |
| 33006904 | Derived | 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. |
| 30036082 | Derived | 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. |
| 28828487 | Derived | 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. |
| 28711468 | Derived | 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. |
| 28616804 | Derived | 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. |
| 28389582 | Derived | 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. |
| 28118453 | Derived | 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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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2019 | Aug 14, 2019 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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