Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Continuous Glucose Monitor
- Registration Number
- NCT02282397
- Lead Sponsor
- DexCom, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1: CGM Continuous Glucose Monitor 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.
- Primary Outcome Measures
Name Time Method Phase 1 (T1DM) - A1C 6 months Change in A1C from baseline to 24 weeks
Phase 2 (T1DM) 6 months Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T2DM) - A1C 6 months Change in A1C from baseline to 24 weeks
- Secondary Outcome Measures
Name Time Method Phase 1 (T1DM) - Insulin Use Outcomes 6 months Change in the number of boluses/day from baseline to 24 weeks
Phase 2 (T1DM) - A1C Outcomes 6 months % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%
Phase 2 (T1DM) - QoL Outcomes 6 months Quality of life changes from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Body Weight 6 months Change in body weight from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - SMBG Outcome 6 months Change in SMBG frequency from baseline to 24 weeks
Phase 1 (T1DM) - Hypoglycemia Awareness 6 months Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
Phase 1 (T1DM) - Adverse Events 6 months Change in the number of DKA events from baseline to 24 weeks
Phase 1 (T1DM) - Body Weight 6 months Change in body weight from baseline to 24 weeks
Phase 1 (T2DM) - A1C Outcomes 6 months % of subjects with a reduction in A1C greater than or equal to 1%
Phase 1 (T2DM) - Hypoglycemia Awareness 6 months Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
Phase 1 (T2DM) - Cost Effectiveness 6 months Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 2 (T1DM) - CGM Outcomes 6 months Area above curve 180 mg/dL (overall, daytime, and nighttime separately)
Phase 2 (T1DM) - CGM Use 6 months Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Cost Effectiveness 6 months Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 2 (T1DM) - Insulin Use Outcomes 6 months Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - A1C Outcomes 6 months % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%
Phase 1 (T1DM) - QoL Outcomes 6 months Quality of life changes from baseline to 24 weeks
Phase 1 (T1DM) - Cost Effectiveness 6 months Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 1 (T2DM) - CGM Outcomes 6 months Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - QoL Outcomes 6 months Quality of life changes from baseline to 24 weeks
Phase 1 (T2DM) - Body Weight 6 months Change in body weight from baseline to 24 weeks
Phase 1 (T2DM) - Insulin Use Outcomes 6 months Change in the number of boluses/day from baseline to 24 weeks
Phase 2 (T1DM) - SMBG 6 months Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - CGM Outcomes 6 months % time greater than 300 mg/dL (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - SMBG 6 months Change in SMBG frequency from baseline to 24 weeks
Phase 1 (T2DM) - Adverse Events 6 months Change in the number of DKA Events from baseline to 24 weeks
Phase 2 (T1DM) - Hypoglycemia Awareness 6 months Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Adverse Events 6 months Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks
Trial Locations
- Locations (27)
Laureate Medical Group at Northside, LLC
🇺🇸Atlanta, Georgia, United States
Mountain Diabetes and Endocrine Center
🇺🇸Asheville, North Carolina, United States
LMC Clinical Research
🇨🇦Toronto, Ontario, Canada
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Granger Medical Clinic
🇺🇸Riverton, Utah, United States
Marin Endocrine Care & Research
🇺🇸Greenbrae, California, United States
Advanced Research Associates
🇺🇸Ogden, Utah, United States
Coastal Metabolic Research Centre
🇺🇸Ventura, California, United States
Amarillo Medical Specialists, LLP
🇺🇸Amarillo, Texas, United States
Physicians Research Associates, LLC
🇺🇸Lawrenceville, Georgia, United States
Rocky Mountain Diabetes & Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Iowa Diabetes & Endocrinology Research Center
🇺🇸Des Moines, Iowa, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Albany Medical College
🇺🇸Albany, New York, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Diabetes & Endocrine Associates, PC
🇺🇸Omaha, Nebraska, United States
Accent Clinical Research
🇺🇸Las Vegas, Nevada, United States
Legacy Research Institute
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Diabetes and Glandular Disease
🇺🇸San Antonio, Texas, United States
Consano Clinical Research
🇺🇸San Antonio, Texas, United States
Endocrine Research Solutions
🇺🇸Roswell, Georgia, United States