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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Artificial Pancreas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months. Age 14.0 to <75.0 years HbA1c level <10.5% at screening For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra) Total daily insulin dose (TDD) less than 100 U/day Exclusion Criteria More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment Medical need for chronic acetaminophen Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals). Hemophilia or any other bleeding disorder A condition, which in the opinion of the investigator or designee, would put the participant or study at risk Participation in another pharmaceutical or device trial at the time of enrollment or during the study Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Pancreas<br>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. | Device: Artificial Pancreas<br>* 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.<br>* Other names: inControl Diabetes Medical Platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM)