Type1 Diabetes MellitusiDCLNCT02985866

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

A study testing Artificial Pancreas and Sensor Augmented Therapy in people with Type1 Diabetes Mellitus, run by University of Virginia at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: Type1 Diabetes Mellitus
What is being tested?: Artificial Pancreas and Sensor Augmented Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 7 sitesUnited States
Study dates: 27 Oct 2017to 4 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
Use of an insulin pump for at least 6 months
Age ≥14 years old
HbA1c level <10.5% at screening
For females, not currently known to be pregnant
Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study

Show all 12Show fewer

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
Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
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)
Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, 02215
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
William Sansum Diabetes Center
Santa Barbara, California, 93105
Stanford University
Stanford, California, 94304

Other trials in United States

About this study

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

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.

Read the 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%.

Conditions: Type1 Diabetes Mellitus
Being tested: Artificial Pancreas, Sensor Augmented Therapy
Keywords: Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM), inControl Diabetes Management Platform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial PancreasDevice
Also called Control-to-Range (CTR) closed-loop (CL)
Use of CTR at home for 3 months
Sensor Augmented TherapyOther
Also called SAP
Use of personal pump with study CGM \& glucometer at home for 3 months

Study groups in NCT02985866
Study group	Role	What they receive
Artificial Pancreas	Experimental	Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Receives: Device: Artificial Pancreas
Sensor Augmented Therapy	Active comparator	Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Receives: Other: Sensor Augmented Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Time Below 70 mg/dL
CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
Measured: Post randomization (final 11 weeks)
Time Above 180 mg/dL
CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)
Measured: Post randomization (final 11 weeks)

Secondary outcomes (7)

Time Below 54 mg/dL
Percent time CGM readings were below 54 mg/dL
Measured: Post randomization (final 11 weeks)
Time Below 60 mg/dL
CGM-measured % time below 60 mg/dL
Measured: Post randomization (final 11 weeks)
Time in Range 70-180 mg/dL
CGM-measured % in range 70-180 mg/dL
Measured: Post randomization (final 11 weeks)
Time in Range 70-140 mg/dL
CGM-measured % time in range 70-140 mg/dL
Measured: Post randomization (final 11 weeks)
Time Above 250 mg/dL
CGM-measured % time above 250 mg/dL
Measured: Post randomization (final 11 weeks)
Time Above 300 mg/dL
CGM-measured % time above 300 mg/dL
Measured: Post randomization (final 11 weeks)
Coefficient of Variation
CGM-measured coefficient of variation (CV)
Measured: Post randomization (final 11 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20174 Sep 2018

First posted7 Dec 2016 (estimated)
Study start27 Oct 2017
Primary completion4 Sep 2018
Study completion4 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02985866
Sponsor's protocol ID: iDCL
Other IDs: UC4DK108483
Acronym: iDCL
Status last verified: Nov 2022
First submitted: 5 Dec 2016
Last updated: 5 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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, meal content, boluses, \& exercise 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.

Publications

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.
PubMed 32245747
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.
PubMed 31937608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Recruiting
Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
Diabetes Mellitus, Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension

All Type1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02985866
Acronym / sponsor ID: iDCL / iDCL
Conditions: Type1 Diabetes Mellitus
Keywords: Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM), inControl Diabetes Management Platform
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, TypeZero Technologies, DexCom, Inc., Roche Diagnostic Ltd., Ascensia Diabetes Care
Study start: 27 Oct 2017 (actual)
Primary completion: 4 Sep 2018 (actual)
Study completion: 4 Sep 2018 (actual)
First posted: 7 Dec 2016 (estimated)
Results: Posted 5 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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%.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Artificial Pancreas	Experimental	Device: Artificial PancreasSubjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
Sensor Augmented Therapy	Active comparator	Other: Sensor Augmented TherapySubjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
Use of an insulin pump for at least 6 months
Age ≥14 years old
HbA1c level <10.5% at screening
For females, not currently known to be pregnant

Key exclusion criteria (7 listed)

Medical need for chronic acetaminophen
Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
Hemophilia or any other bleeding disorder
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
Participation in another pharmaceutical or device trial at the time of enrollment or during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Artificial PancreasAlso: Control-to-Range (CTR) closed-loop (CL)Use of CTR at home for 3 months	Device	Artificial Pancreas
Sensor Augmented TherapyAlso: SAPUse of personal pump with study CGM \& glucometer at home for 3 months	Other	Sensor Augmented Therapy

Primary outcome

Time Below 70 mg/dL
Time frame: Post randomization (final 11 weeks)
CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
Time Above 180 mg/dL
Time frame: Post randomization (final 11 weeks)
CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)

7 secondary outcomes

Time Below 54 mg/dL
Time frame: Post randomization (final 11 weeks)
Time Below 60 mg/dL
Time frame: Post randomization (final 11 weeks)
Time in Range 70-180 mg/dL
Time frame: Post randomization (final 11 weeks)
Time in Range 70-140 mg/dL
Time frame: Post randomization (final 11 weeks)
Time Above 250 mg/dL
Time frame: Post randomization (final 11 weeks)
Time Above 300 mg/dL
Time frame: Post randomization (final 11 weeks)
Coefficient of Variation
Time frame: Post randomization (final 11 weeks)

Results and safety

Results posted to the registry on 5 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Artificial Pancreas (Closed Loop Control)	65	64
Sensor Augmented Therapy	62	61

Primary outcome: Time Below 70 mg/dL

Time frame: Post randomization (final 11 weeks). Mean (Standard Deviation). Unit: percentage of total CGM time

Measure	Artificial Pancreas (Closed Loop Control) n = 64	Sensor Augmented Therapy n = 61
Value	2.4 (1.7)	4.0 (3.4)

Artificial Pancreas (Closed Loop Control) vs Sensor Augmented Therapy: p <0.0001, Mixed Models Analysis

Primary outcome: Time Above 180 mg/dL

Time frame: Post randomization (final 11 weeks). Mean (Standard Deviation). Unit: percentage of total CGM time

Measure	Artificial Pancreas (Closed Loop Control) n = 64	Sensor Augmented Therapy n = 61
Value	34 (11)	39 (15)

Artificial Pancreas (Closed Loop Control) vs Sensor Augmented Therapy: p <0.0001, Mixed Models Analysis

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Artificial Pancreas (Closed Loop Control)	1 of 65 (1.5%)	0 of 65 (0%)	0 of 65
Sensor Augmented Therapy	0 of 62 (0%)	2 of 62 (3.2%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32245747Kovatchev 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.
Results publication: PubMed 31937608Kovatchev 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.
Individual participant dataSharing planned: Yes. 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, meal content, boluses, \& exercise 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.

Related trials for Type1 Diabetes Mellitus

Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Recruiting
Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
Diabetes Mellitus, Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boris P. Kovatchev, PhD principal investigator

University of Virginia Center for Diabetes Technology

Stacey M. Anderson, MD study chair

University of Virginia Center for Diabetes Technology

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Pancreas and Sensor Augmented Therapy in people with Type1 Diabetes Mellitus, run by University of Virginia at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Below 70 mg/dL (time frame: Post randomization (final 11 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985866, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.