search
Back to results

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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interoperable Artificial Pancreas System (iAPS)
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Sponsored by
Sansum Diabetes Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Artificial Pancreas, Automated Insulin Delivery, Closed Loop Control, Continuous Glucose Monitor (CGM), interoperable Artificial Pancreas System (iAPS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sansum Diabetes Research Institute
  • Stanford University
  • Joslin Diabetes Center
  • Mayo Clinic
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial Pancreas

Sensor Augmented Pump/Predictive Low Glucose Suspend

Arm 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.

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.

Outcomes

Primary Outcome Measures

Percent CGM Time in Range 70-180 mg/dL
This results shown is mean percent time in range 70-180 mg/dL.
Non-inferiority for CGM Time <54 mg/dL
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

Secondary Outcome Measures

CGM Mean Glucose
CGM-measured mean glucose (mg/dL)
CGM Time > 180
CGM time > 180 mg/dL
CGM Time > 250
CGM time > 250 mg/dL
CGM Time < 70
CGM time < 70 mg/dL
CGM Time < 54 (Superiority)
CGM time < 54 mg/dL (Superiority)
Coefficient of Variation
CGM measured glucose variability measured with the coefficient of variation (CV)
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Standard Deviation
CGM measured glucose variability measured with the standard deviation (SD)
CGM Time < 60
CGM time < 60 mg/dL
LBGI
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.
CGM Time > 300
CGM time > 300 mg/dL
HBGI
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
HbA1c at 13 Weeks
Hemiglobin A1c measured after completing each study arm
Number of Participants With HbA1c <7.0% at 13 Weeks
Number of participants HbA1c <7.0% after completing each study arm
Number of Participants With HbA1c <7.5% at 13 Weeks
Number of participants HbA1c <7.5% after completing each study arm
Diabetes Distress Scale at 13 Weeks - Total Score
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.
Glucose Monitoring Satisfaction Survey (Total Scale)
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)
Hypoglycemia Confidence Scale
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.
INSPIRE Survey Scores - Following Study System Period Only
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.
SUS Survey Scores - Following Study System Period
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Total Daily Insulin
Total Daily Insulin (units)
Basal: Bolus Insulin Ratio
Basal: bolus insulin ratio

Full Information

First Posted
June 16, 2020
Last Updated
November 8, 2022
Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research
search

1. Study Identification

Unique Protocol Identification Number
NCT04436796
Brief Title
The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
Acronym
DCLP4
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Artificial Pancreas, Automated Insulin Delivery, Closed Loop Control, Continuous Glucose Monitor (CGM), interoperable Artificial Pancreas System (iAPS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Pancreas
Arm Type
Experimental
Arm 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.
Arm Title
Sensor Augmented Pump/Predictive Low Glucose Suspend
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
interoperable Artificial Pancreas System (iAPS)
Intervention Description
Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
Intervention Type
Other
Intervention Name(s)
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Intervention Description
Use of personal pump with study CGM & glucometer at home for 13 weeks.
Primary Outcome Measure Information:
Title
Percent CGM Time in Range 70-180 mg/dL
Description
This results shown is mean percent time in range 70-180 mg/dL.
Time Frame
13 weeks
Title
Non-inferiority for CGM Time <54 mg/dL
Description
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
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
CGM Mean Glucose
Description
CGM-measured mean glucose (mg/dL)
Time Frame
13 weeks
Title
CGM Time > 180
Description
CGM time > 180 mg/dL
Time Frame
13 weeks
Title
CGM Time > 250
Description
CGM time > 250 mg/dL
Time Frame
13 weeks
Title
CGM Time < 70
Description
CGM time < 70 mg/dL
Time Frame
13 weeks
Title
CGM Time < 54 (Superiority)
Description
CGM time < 54 mg/dL (Superiority)
Time Frame
13 weeks
Title
Coefficient of Variation
Description
CGM measured glucose variability measured with the coefficient of variation (CV)
Time Frame
13 weeks
Title
CGM Time in Range 70-140 mg/dL
Description
CGM-measured % in range 70-140 mg/dL
Time Frame
13 weeks
Title
Standard Deviation
Description
CGM measured glucose variability measured with the standard deviation (SD)
Time Frame
13 weeks
Title
CGM Time < 60
Description
CGM time < 60 mg/dL
Time Frame
13 weeks
Title
LBGI
Description
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.
Time Frame
13 weeks
Title
CGM Time > 300
Description
CGM time > 300 mg/dL
Time Frame
13 weeks
Title
HBGI
Description
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
Time Frame
13 weeks
Title
HbA1c at 13 Weeks
Description
Hemiglobin A1c measured after completing each study arm
Time Frame
13 weeks
Title
Number of Participants With HbA1c <7.0% at 13 Weeks
Description
Number of participants HbA1c <7.0% after completing each study arm
Time Frame
13 weeks
Title
Number of Participants With HbA1c <7.5% at 13 Weeks
Description
Number of participants HbA1c <7.5% after completing each study arm
Time Frame
3 months
Title
Diabetes Distress Scale at 13 Weeks - Total Score
Description
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.
Time Frame
13 weeks
Title
Glucose Monitoring Satisfaction Survey (Total Scale)
Description
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)
Time Frame
13 weeks
Title
Hypoglycemia Confidence Scale
Description
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.
Time Frame
13 weeks
Title
INSPIRE Survey Scores - Following Study System Period Only
Description
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.
Time Frame
13 weeks
Title
SUS Survey Scores - Following Study System Period
Description
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Time Frame
13 weeks
Title
Total Daily Insulin
Description
Total Daily Insulin (units)
Time Frame
13 weeks
Title
Basal: Bolus Insulin Ratio
Description
Basal: bolus insulin ratio
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
Title
CGM Metrics by Time of Day
Description
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).
Time Frame
13 weeks
Title
Number of Participants With Severe Hypoglycemia (Per Protocol)
Description
Severe hypoglycemia (per protocol)
Time Frame
13 weeks
Title
Number of Participants With Diabetic Ketoacidosis (Per Protocol)
Description
Diabetic ketoacidosis (per protocol)
Time Frame
13 weeks
Title
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Description
Ketone events defined as day with ketone level >1.0 mmol/L
Time Frame
13 weeks
Title
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
Description
CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) in each arm.
Time Frame
3 months
Title
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
Description
CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) in each arm.
Time Frame
3 months
Title
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
Description
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
Time Frame
13 weeks
Title
Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
Description
Worsening of HbA1c from baseline to 26 weeks by >0.5%
Time Frame
13 weeks
Title
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
Description
Other serious adverse events (SAE) and serious adverse device events (SADE)
Time Frame
13 weeks
Title
Adverse Device Effects (ADE)
Description
Adverse device effects (ADE)
Time Frame
13 weeks
Title
Unanticipated Adverse Device Effects (UADE)
Description
Unanticipated adverse device effects (UADE)
Time Frame
13 weeks
Title
Number of Participants With SH Events
Description
For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
Time Frame
13 weeks
Title
SH Event Rate Per 100 Person-years
Description
For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
Time Frame
13 weeks
Title
Number of Participants With DKA Events
Description
For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
Time Frame
13 weeks
Title
DKA Event Rate Per 100 Person-years
Description
For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
Time Frame
13 weeks
Title
Any Adverse Event Rate Per 100 Person-years
Description
For this outcome, the adverse event rate per 100 person-years calculated as a rate.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Dassau, PhD
Organizational Affiliation
Harvard University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jordan Pinsker, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis J Doyle III, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35549708
Citation
Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs