Clinical trial NCT02282397: Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Official title: Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2014-11-04
Enrollment: 316
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Phase 1 (T1DM) - A1C
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C
timeFrame: 6 months
measure: Phase 2 (T1DM)
timeFrame: 6 months
Secondary outcomes:
measure: Phase 1 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - Hypoglycemia Awareness
timeFrame: 6 months
measure: Phase 1 (T1DM) - SMBG Outcome
timeFrame: 6 months
measure: Phase 1 (T1DM) - QoL Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - Cost Effectiveness
timeFrame: 6 months
measure: Phase 1 (T1DM) - Adverse Events
timeFrame: 6 months
measure: Phase 1 (T1DM) - Adverse Events
timeFrame: 6 months
measure: Phase 1 (T1DM) - Body Weight
timeFrame: 6 months
measure: Phase 1 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - Hypoglycemia Awareness
timeFrame: 6 months
measure: Phase 1 (T2DM) - SMBG
timeFrame: 6 months
measure: Phase 1 (T2DM) - QoL Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - Cost Effectiveness
timeFrame: 6 months
measure: Phase 1 (T2DM) - Adverse Events
timeFrame: 6 months
measure: Phase 1 (T2DM) - Adverse Events
timeFrame: 6 months
measure: Phase 1 (T2DM) - Body Weight
timeFrame: 6 months
measure: Phase 1 (T2DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - A1C Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - Hypoglycemia Awareness
timeFrame: 6 months
measure: Phase 2 (T1DM) - CGM Use
timeFrame: 6 months
measure: Phase 2 (T1DM) - SMBG
timeFrame: 6 months
measure: Phase 2 (T1DM) - QoL Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - Cost Effectiveness
timeFrame: 6 months
measure: Phase 2 (T1DM) - Adverse Events
timeFrame: 6 months
measure: Phase 2 (T1DM) - Adverse Events
timeFrame: 6 months
measure: Phase 2 (T1DM) - Body Weight
timeFrame: 6 months
measure: Phase 2 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
measure: Phase 2 (T1DM) - Insulin Use Outcomes
timeFrame: 6 months
Other outcomes:
measure: Phase 1 (T1DM) - Post-Hoc CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T1DM) - Post-Hoc CGM Outcomes
timeFrame: 6 months
measure: Phase 1 (T2DM) - Post-Hoc A1C Outcome
timeFrame: 6 months
Locations:
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Centre
state: California
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Laureate Medical Group at Northside, LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes & Osteoporosis Center
state: Idaho
city: Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center
state: Iowa
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Omaha
country: United States
facility: Diabetes & Endocrine Associates, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Accent Clinical Research
state: Nevada
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Amarillo
country: United States
facility: Amarillo Medical Specialists, LLP
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease
state: Texas
city: San Antonio
country: United States
facility: Consano Clinical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Associates
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clinic
state: Utah
city: Barrie
country: Canada
facility: LMC Clinical Research
state: Ontario
city: Thornhill
country: Canada
facility: LMC Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research
state: Ontario
Study officials:
affiliation: DexCom, Inc.
name: David Price, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.