Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Participation in this study will require 5 study visits over 2-4 weeks.
- Visit 1: screening/enrollment visit to assess study eligibility.
- Visit 2: continuous glucose monitor (CGM) training and initiation session based upon
current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be
trained and may be asked to wear the CGM at home for 1 week.
- Visit 3: subjects will be taught how to use the study insulin pump.
- Visit 4: subjects will be trained on the use of inControl and wear it at home for 14
days.
- Visit 5: subjects will return study equipment and to complete questionnaire.
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