Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DexCom, Inc.
With
Jaeb Center for Health Research
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.
Age
25–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
