The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

Study Overview
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Brief Summary
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The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Detailed Description
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The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects. In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%.

Official Title
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Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

Conditions
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Type1 Diabetes Mellitus

Intervention / Treatment
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* Device: Artificial Pancreas
* Other: Sensor Augmented Therapy


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 Age ≥14 years old HbA1c level <10.5% at screening For females, not currently known to be pregnant Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service 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) Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency Exclusion Criteria: Medical need for chronic acetaminophen Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment 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 including any contraindication to the use of any of the study devices per FDA labeling Participation in another pharmaceutical or device trial at the time of enrollment or during the study Use of a closed-loop system within the last month prior to enrollment Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Ages Eligible for Study
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Minimum Age: 14 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Pancreas<br>Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. | Device: Artificial Pancreas<br>* Use of CTR at home for 3 months<br>* Other names: Control-to-Range (CTR) closed-loop (CL);|
| Active Comparator: Sensor Augmented Therapy<br>Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. | Other: Sensor Augmented Therapy<br>* Use of personal pump with study CGM & glucometer at home for 3 months<br>* Other names: SAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Below 70 mg/dL | CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority) | Post randomization (final 11 weeks) | 
| Time Above 180 mg/dL | CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority) | Post randomization (final 11 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Below 54 mg/dL | Percent time CGM readings were below 54 mg/dL | Post randomization (final 11 weeks) | 
| Time Below 60 mg/dL | CGM-measured % time below 60 mg/dL | Post randomization (final 11 weeks) | 
| Time in Range 70-180 mg/dL | CGM-measured % in range 70-180 mg/dL | Post randomization (final 11 weeks) | 
| Time in Range 70-140 mg/dL | CGM-measured % time in range 70-140 mg/dL | Post randomization (final 11 weeks) | 
| Time Above 250 mg/dL | CGM-measured % time above 250 mg/dL | Post randomization (final 11 weeks) | 
| Time Above 300 mg/dL | CGM-measured % time above 300 mg/dL | Post randomization (final 11 weeks) | 
| Coefficient of Variation | CGM-measured coefficient of variation (CV) | Post randomization (final 11 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), inControl Diabetes Management Platform