The International Diabetes Closed Loop (iDCL) Trial: Protocol 4 (DCLP4)

November 8, 2022 updated by: Sansum Diabetes Research Institute

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
      • Stanford, California, United States, 94304
        • Stanford University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artificial Pancreas
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.
Device: interoperable Artificial Pancreas System (iAPS)
Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
Active Comparator: Sensor Augmented Pump/Predictive Low Glucose Suspend
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.
Other: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Use of personal pump with study CGM & glucometer at home for 13 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent CGM Time in Range 70-180 mg/dL
Time Frame: 13 weeks
This results shown is mean percent time in range 70-180 mg/dL.
13 weeks
Non-inferiority for CGM Time <54 mg/dL
Time Frame: 13 weeks
Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure
13 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CGM Time in Range 70-140 mg/dL
Time Frame: 13 weeks
CGM-measured % in range 70-140 mg/dL
13 weeks
Coefficient of Variation
Time Frame: 13 weeks
CGM measured glucose variability measured with the coefficient of variation (CV)
13 weeks
Standard Deviation
Time Frame: 13 weeks
CGM measured glucose variability measured with the standard deviation (SD)
13 weeks
CGM Mean Glucose
Time Frame: 13 weeks
CGM-measured mean glucose (mg/dL)
13 weeks
CGM Time > 180
Time Frame: 13 weeks
CGM time > 180 mg/dL
13 weeks
CGM Time > 250
Time Frame: 13 weeks
CGM time > 250 mg/dL
13 weeks
CGM Time < 70
Time Frame: 13 weeks
CGM time < 70 mg/dL
13 weeks
CGM Time < 54 (Superiority)
Time Frame: 13 weeks
CGM time < 54 mg/dL (Superiority)
13 weeks
CGM Time < 60
Time Frame: 13 weeks
CGM time < 60 mg/dL
13 weeks
LBGI
Time Frame: 13 weeks
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.
13 weeks
CGM Time > 300
Time Frame: 13 weeks
CGM time > 300 mg/dL
13 weeks
HBGI
Time Frame: 13 weeks
High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia
13 weeks
HbA1c at 13 Weeks
Time Frame: 13 weeks
Hemiglobin A1c measured after completing each study arm
13 weeks
Number of Participants With HbA1c <7.0% at 13 Weeks
Time Frame: 13 weeks
Number of participants HbA1c <7.0% after completing each study arm
13 weeks
Number of Participants With HbA1c <7.5% at 13 Weeks
Time Frame: 3 months
Number of participants HbA1c <7.5% after completing each study arm
3 months
Diabetes Distress Scale at 13 Weeks - Total Score
Time Frame: 13 weeks
Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
13 weeks
Glucose Monitoring Satisfaction Survey (Total Scale)
Time Frame: 13 weeks
The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)
13 weeks
Hypoglycemia Confidence Scale
Time Frame: 13 weeks
Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
13 weeks
INSPIRE Survey Scores - Following Study System Period Only
Time Frame: 13 weeks
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.
13 weeks
SUS Survey Scores - Following Study System Period
Time Frame: 13 weeks
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
13 weeks
Total Daily Insulin
Time Frame: 13 weeks
Total Daily Insulin (units)
13 weeks
Basal: Bolus Insulin Ratio
Time Frame: 13 weeks
Basal: bolus insulin ratio
13 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CGM Metrics by Time of Day
Time Frame: 13 weeks
Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).
13 weeks
Number of Participants With Severe Hypoglycemia (Per Protocol)
Time Frame: 13 weeks
Severe hypoglycemia (per protocol)
13 weeks
Number of Participants With Diabetic Ketoacidosis (Per Protocol)
Time Frame: 13 weeks
Diabetic ketoacidosis (per protocol)
13 weeks
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Time Frame: 13 weeks
Ketone events defined as day with ketone level >1.0 mmol/L
13 weeks
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
Time Frame: 3 months
CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) in each arm.
3 months
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
Time Frame: 3 months
CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) in each arm.
3 months
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
Time Frame: 13 weeks
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
13 weeks
Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
Time Frame: 13 weeks
Worsening of HbA1c from baseline to 26 weeks by >0.5%
13 weeks
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
Time Frame: 13 weeks
Other serious adverse events (SAE) and serious adverse device events (SADE)
13 weeks
Adverse Device Effects (ADE)
Time Frame: 13 weeks
Adverse device effects (ADE)
13 weeks
Unanticipated Adverse Device Effects (UADE)
Time Frame: 13 weeks
Unanticipated adverse device effects (UADE)
13 weeks
Number of Participants With SH Events
Time Frame: 13 weeks
For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
13 weeks
SH Event Rate Per 100 Person-years
Time Frame: 13 weeks
For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
13 weeks
Number of Participants With DKA Events
Time Frame: 13 weeks
For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
13 weeks
DKA Event Rate Per 100 Person-years
Time Frame: 13 weeks
For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
13 weeks
Any Adverse Event Rate Per 100 Person-years
Time Frame: 13 weeks
For this outcome, the adverse event rate per 100 person-years calculated as a rate.
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sansum Diabetes Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Harvard University
Jaeb Center for Health Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jordan Pinsker, MD, Sansum Diabetes Research Institute
  • Study Chair: Eyal Dassau, PhD, Harvard University
  • Principal Investigator: Francis J Doyle III, PhD, Harvard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G200047
  • UC4DK108483 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series & boluses, will be deidentified & retrievable only by subject ID number. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes & not to identify participants; (2) a commitment to securing the data using appropriate computer technology; & (3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

The dataset from each iDCL protocol will be made public after publication of all manuscripts written by the study group using the dataset and any regulatory submission/completion of review by the regulatory agency, but no later than 3 years after the completion of the protocol even if additional manuscripts or regulatory submissions are planned.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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