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

Not Applicable

Completed

Brief Summary: 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: 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%.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sensor Augmented Therapy	Sensor Augmented Therapy	Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.
Artificial Pancreas	Artificial Pancreas	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time Below 54 mg/dL	Post randomization (final 11 weeks)	Percent time CGM readings were below 54 mg/dL
Time in Range 70-180 mg/dL	Post randomization (final 11 weeks)	CGM-measured % in range 70-180 mg/dL
Time in Range 70-140 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time in range 70-140 mg/dL
Time Above 250 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time above 250 mg/dL
Time Above 300 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time above 300 mg/dL
Coefficient of Variation	Post randomization (final 11 weeks)	CGM-measured coefficient of variation (CV)
Time Below 60 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time below 60 mg/dL

Locations (7): Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Stanford University
🇺🇸
Stanford, California, United States
William Sansum Diabetes Center
🇺🇸
Santa Barbara, California, United States
Harvard University (Joslin Diabetes Center)
🇺🇸
Boston, Massachusetts, United States
Barbara Davis Center, University of Colorado
🇺🇸
Aurora, Colorado, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
University of Virginia Center for Diabetes Technology
🇺🇸
Charlottesville, Virginia, United States