NCT02282397

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor	RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-11-04
• Last updated: 2017-05-15

Locations

30 sites across 2 countries: United States, Canada