Clinical trial NCT02985866: The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Keywords: Artificial Pancreas
Closed Loop Control
Continuous Glucose Monitor (CGM)
inControl Diabetes Management Platform
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Jaeb Center for Health Research
name: TypeZero Technologies
name: DexCom, Inc.
name: Roche Diagnostic Ltd.
name: Ascensia Diabetes Care
First posted: 2016-12-07
Enrollment: 127
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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%.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
2. Use of an insulin pump for at least 6 months
3. Age ≥14 years old
4. HbA1c level \<10.5% at screening
5. For females, not currently known to be pregnant
6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study
7. 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
8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
10. 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)
11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
12. 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:

1. Medical need for chronic acetaminophen
2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
3. Hemophilia or any other bleeding disorder
4. 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
5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
6. Use of a closed-loop system within the last month prior to enrollment
7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Primary outcomes:
measure: Time Below 70 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time Above 180 mg/dL
timeFrame: Post randomization (final 11 weeks)
Secondary outcomes:
measure: Time Below 54 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time Below 60 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time in Range 70-180 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time in Range 70-140 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time Above 250 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Time Above 300 mg/dL
timeFrame: Post randomization (final 11 weeks)
measure: Coefficient of Variation
timeFrame: Post randomization (final 11 weeks)
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center, University of Colorado
state: Colorado
city: Boston
country: United States
facility: Harvard University (Joslin Diabetes Center)
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia Center for Diabetes Technology
name: Boris P. Kovatchev, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Center for Diabetes Technology
name: Stacey M. Anderson, MD
role: STUDY_CHAIR
References:
citation: Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available.
citation: Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14.