Diabetes Mellitus, Type 1NCT02844517
International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
A study testing Artificial Pancreas in people with Diabetes Mellitus, Type 1, run by University of Virginia at 10 sites in 4 countries.
Trial summary
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial. Read more about this study
- Who is it for?
- Ages 14 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Artificial Pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Nov 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 74 years
- 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 with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
- Age 14.0 to <75.0 years
- HbA1c level <10.5% at screening
- 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 premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
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- Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
- 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)
- Total daily insulin dose (TDD) less than 100 U/day
Who cannot join
- More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
- Medical need for chronic acetaminophen
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
- 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
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by TypeZero Technologies, LLC
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
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
Mt. Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55902
William Sansum Diabetes Center
Santa Barbara, California, 93105
Stanford University
Stanford, California, 94304
About this study
Official title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Read the detailed description
Participation in this study will require 5 study visits over 2-4 weeks.
- Visit 1: screening/enrollment visit to assess study eligibility.
- Visit 2: continuous glucose monitor (CGM) training and initiation session based upon current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be trained and may be asked to wear the CGM at home for 1 week.
- Visit 3: subjects will be taught how to use the study insulin pump.
- Visit 4: subjects will be trained on the use of inControl and wear it at home for 14 days.
- Visit 5: subjects will return study equipment and to complete questionnaire.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Artificial Pancreas
- Keywords
- Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial PancreasDevice
Also called inControl Diabetes Medical Platform
Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Pancreas | Experimental | The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff. Receives: Device: Artificial Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, TypeZero Technologies, LLC, Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostic Ltd.
- Responsible party
- Principal investigator, Stacey Anderson, University of Virginia
- Investigators
- Boris P. Kovatchev, PhD, Principal investigator, University of Virginia Center for Diabetes TechnologyStacey M. Anderson, MD, Study chair, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844517
- Sponsor's protocol ID
- 19068
- Other IDs
- UC4DK108483
- Status last verified
- May 2018
- First submitted
- 21 Jul 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Not yet determined
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. 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 Research Site Training Protocol
- ClinicalTrials.gov ID
- NCT02844517
- Acronym / sponsor ID
- 19068
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 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, LLC, Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostic Ltd.
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
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 for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Detailed description
Participation in this study will require 5 study visits over 2-4 weeks.
- Visit 1: screening/enrollment visit to assess study eligibility.
- Visit 2: continuous glucose monitor (CGM) training and initiation session based upon current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be trained and may be asked to wear the CGM at home for 1 week.
- Visit 3: subjects will be taught how to use the study insulin pump.
- Visit 4: subjects will be trained on the use of inControl and wear it at home for 14 days.
- Visit 5: subjects will return study equipment and to complete questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Artificial Pancreas | Experimental | Device: Artificial PancreasThe primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff. |
Who may qualify
- Ages
- 14 to 74 years
- 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 with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
- Age 14.0 to <75.0 years
- HbA1c level <10.5% at screening
- 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 premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
Key exclusion criteria (8 listed)
- More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
- Medical need for chronic acetaminophen
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
- Hemophilia or any other bleeding disorder
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: inControl Diabetes Medical PlatformSubjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes. | Device | Artificial Pancreas |
Primary outcome
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: Yes. Not yet determined
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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
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Pancreas in people with Diabetes Mellitus, Type 1, run by University of Virginia at 10 sites in 4 countries.
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 8 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France, Italy, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.