Type 1 Diabetes Mellitus Clinical Trial
Official title:
Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose
Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic
control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes
mellitus on MDI or CSII therapy.
The primary objective of this study is to demonstrate no statistically significant
differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to
baseline. A secondary objective is to evaluate time spent outside of the euglycemic region
(70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.
Safety data of the SEVEN PLUS System will also be collected and safety will be characterized
by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated
Adverse Device Effects experienced by study participants.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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