Status:
COMPLETED
Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Lead Sponsor:
DexCom, Inc.
Collaborating Sponsors:
Jaeb Center for Health Research
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
25+ years
Phase:
NA
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) te...
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 independ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT02282397
Start Date
September 1 2014
End Date
November 1 2016
Last Update
May 15 2017
Active Locations (30)
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1
Marin Endocrine Care & Research
Greenbrae, California, United States, 94904
2
Coastal Metabolic Research Centre
Ventura, California, United States, 93003
3
East Coast Institute for Research, LLC
Jacksonville, Florida, United States, 32204
4
East Coast Institute for Research, LLC
Jacksonville, Florida, United States, 32216