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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Artificial Pancreas

• Registration Number: NCT02844517
• Lead Sponsor: University of Virginia

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Study Start: 2016-11
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artificial Pancreas	Artificial Pancreas	The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.

Primary Outcome Measures

Name	Time	Method
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.	2 weeks

Trial Locations

Locations (10)

Stanford University; 🇺🇸 Stanford, California, United States

Mt. Sinai; 🇺🇸 New York, New York, United States

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States

University of Padova; 🇮🇹 Padova, Italy

University of Montpellier; 🇫🇷 Montpellier, France

William Sansum Diabetes Center; 🇺🇸 Santa Barbara, California, United States

Barbara Davis Center, University of Colorado; 🇺🇸 Aurora, Colorado, United States

Harvard University (Joslin Diabetes Center); 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands