Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
NCT ID: NCT02282397
Last Updated: 2017-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
316 participants
INTERVENTIONAL
2014-09-30
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
No interventions assigned to this group
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.
Continuous Glucose Monitor
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
Phase 2: CGM/MDI
Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management.
No interventions assigned to this group
Phase 2: CGM/CSII
Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management.
No interventions assigned to this group
Interventions
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Continuous Glucose Monitor
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
ALL
No
Sponsors
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Jaeb Center for Health Research
OTHER
DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Price, MD
Role: STUDY_DIRECTOR
DexCom, Inc.
Locations
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Marin Endocrine Care & Research
Greenbrae, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Laureate Medical Group at Northside, LLC
Atlanta, Georgia, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States
Iowa Diabetes & Endocrinology Research Center
Des Moines, Iowa, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Diabetes & Endocrine Associates, PC
Omaha, Nebraska, United States
Accent Clinical Research
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States
Legacy Research Institute
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Amarillo Medical Specialists, LLP
Amarillo, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Diabetes and Glandular Disease
San Antonio, Texas, United States
Consano Clinical Research
San Antonio, Texas, United States
Advanced Research Associates
Ogden, Utah, United States
Granger Medical Clinic
Riverton, Utah, United States
LMC Clinical Research
Barrie, Ontario, Canada
LMC Clinical Research
Thornhill, Ontario, Canada
LMC Clinical Research
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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PTL-901148
Identifier Type: -
Identifier Source: org_study_id
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