The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)

Sponsors

Lead Sponsor: Sansum Diabetes Research Institute

Collaborator: Harvard University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research

Source Sansum Diabetes Research Institute
Brief Summary

The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.

Detailed Description

A randomized crossover trial will compare the efficacy and safety of an automated insulin delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for 10-14 days will be conducted prior to the crossover trial.

Overall Status Recruiting
Start Date August 5, 2020
Completion Date September 1, 2021
Primary Completion Date July 15, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
CGM Time in Range 70-180 mg/dL 13 weeks
Non-inferiority for CGM time <54 mg/dL 13 weeks
Secondary Outcome
Measure Time Frame
CGM Mean Glucose 13 weeks
CGM Time > 180 13 weeks
CGM Time > 250 13 weeks
CGM Time < 70 13 weeks
CGM Time < 54 (Superiority) 13 weeks
Coefficient of Variation 13 weeks
CGM Time in Range 70-140 mg/dL 13 weeks
Standard Deviation 13 weeks
CGM Time < 60 13 weeks
LBGI 13 weeks
CGM Hypoglycemia Events 13 weeks
CGM Time > 300 13 weeks
HBGI 13 weeks
HbA1c at 13 weeks 13 weeks
Number of Participants With HbA1c <7.0% at 13 weeks 13 weeks
Number of Participants With HbA1c <7.5% at 13 weeks 3 months
HbA1c improvement from baseline to 13 weeks >0.5% 13 weeks
HbA1c improvement from baseline to 13 weeks >1% 13 weeks
HbA1c relative improvement from baseline to 13 weeks >10% 13 weeks
Number of Participants With HbA1c Improvement From Baseline to 3 months >1.0% or HbA1c <7.0% after 3 months 13 weeks
Diabetes Distress Scale at 13 weeks - total score and 4 subscales: Emotional burden, Physician-related distress, Regimen-related distress, Interpersonal distress 13 weeks
Glucose Monitoring Satisfaction Survey 13 weeks
Hypoglycemia Confidence Scale 13 weeks
Diabetes Technology Attitudes Survey 13 weeks
INSPIRE survey scores - following study system period only 13 weeks
SUS survey scores - following study system period 13 weeks
Total Daily Insulin 13 weeks
Basal: bolus insulin ratio 13 weeks
Weight 13 weeks
BMI 13 weeks
Enrollment 35
Condition
Intervention

Intervention Type: Device

Intervention Name: interoperable Artificial Pancreas System (iAPS)

Description: Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.

Arm Group Label: Artificial Pancreas

Intervention Type: Other

Intervention Name: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)

Description: Use of personal pump with study CGM & glucometer at home for 13 weeks.

Arm Group Label: Sensor Augmented Pump/Predictive Low Glucose Suspend

Eligibility

Criteria:

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 - Using an insulin pump for at least 3 months (which may include use of automated features) - Familiarity and use of a carbohydrate ratio for meal boluses - Age ≥18.0 years old - 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 females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. - If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study - Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only - Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study - Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial - Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol Exclusion Criteria: - Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial. - Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months - Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months - Hemophilia or any other bleeding disorder - A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment - Participation in another pharmaceutical or device trial at the time of enrollment or during the study

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: John Lum

Phone: (813) 975-8690

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Sansum Diabetes Research Institute | Santa Barbara, California, 93105, United States Recruiting Mei Mei Church Jordan E Pinsker, MD Principal Investigator
Stanford University | Stanford, California, 94304, United States Recruiting Liana Hsu Bruce Buckingham, MD Principal Investigator
Joslin Diabetes Center | Boston, Massachusetts, 02215, United States Recruiting Emily Freiner Lori Laffel, MD Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Shelly McCrady-Spitzer Yogish Kudva, MBBS Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Recruiting Selassie Ogyaadu Carol Levy, MD Principal Investigator
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Artificial Pancreas

Type: Experimental

Description: Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.

Label: Sensor Augmented Pump/Predictive Low Glucose Suspend

Type: Active Comparator

Description: Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.

Acronym DCLP4
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov