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

Type1 Diabetes Mellitus Clinical Trial

— iDCL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985866
• Other study ID #: iDCL
• Secondary ID: UC4DK108483
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: September 4, 2018

Study information

• Verified date: November 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• Artificial Pancreas
Use of CTR at home for 3 months

Other:
• Sensor Augmented Therapy
Use of personal pump with study CGM & glucometer at home for 3 months

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
University of Virginia	Ascensia Diabetes Care, DexCom, Inc., Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Roche Diagnostic Ltd., TypeZero Technologies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Below 70 mg/dL	CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)	Post randomization (final 11 weeks)
Primary	Time Above 180 mg/dL	CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)	Post randomization (final 11 weeks)
Secondary	Time Below 54 mg/dL	Percent time CGM readings were below 54 mg/dL	Post randomization (final 11 weeks)
Secondary	Time Below 60 mg/dL	CGM-measured % time below 60 mg/dL	Post randomization (final 11 weeks)
Secondary	Time in Range 70-180 mg/dL	CGM-measured % in range 70-180 mg/dL	Post randomization (final 11 weeks)
Secondary	Time in Range 70-140 mg/dL	CGM-measured % time in range 70-140 mg/dL	Post randomization (final 11 weeks)
Secondary	Time Above 250 mg/dL	CGM-measured % time above 250 mg/dL	Post randomization (final 11 weeks)
Secondary	Time Above 300 mg/dL	CGM-measured % time above 300 mg/dL	Post randomization (final 11 weeks)
Secondary	Coefficient of Variation	CGM-measured coefficient of variation (CV)	Post randomization (final 11 weeks)