NCT02844517

International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Artificial Pancreas	Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-07-26
• Last updated: 2018-05-07

Locations

10 sites across 4 countries: United States, France, Italy, Netherlands

Regulatory

• FDA-regulated device study