Type 1 DiabetesOCLNCT01857973
Overnight Closed Loop Study in U.S.
A study testing Hybrid Closed Loop in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 6 sites in United States.
Trial summary
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hybrid Closed Loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Oct 2016
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 2-75 years of age at time of screening
- A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis
- Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures :
- Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
- Adequate venous access as assessed by investigator or appropriate staff
- Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
- Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
- Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Barbara Davis Center, 1775 Aurora Court, A140
Aurora, Colorado, 80045
University of Virginia, 617 West Main Street, 4th Floor
Charlottesville, Virginia, 22903
AMCR Institute, Inc. 700 West El Norte Parkway, Suite 201
Escondido, California, 92026
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Yale University School of Medicine, 2 Church Street South, Suite 404
New Haven, Connecticut, 06519
Rainier Clinical Research, 723 SW 10th Street, Suite 100
Renton, Washington, 98057
About this study
Official title: In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
Read the detailed description
Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.
The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.
The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.
- Conditions
- Type 1 Diabetes
- Being tested
- Hybrid Closed Loop
- Keywords
- HCL, Type 1 Diabetes, Sensor
- 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.
Hybrid Closed LoopDevice
The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Closed Loop | Experimental | In-clinic evaluation of the HCL System under various conditions. Receives: Device: Hybrid Closed Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.
Measured: 12 days
Secondary outcomes (7)
Percentage of Time in Euglycemic Range - Exploratory A Phase
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery.
Measured: 1 day
Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase
The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin.
Measured: 1 day
Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1
Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1
Measured: 1 day
Percentage of Time in Euglycemic Range - Phase 2
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2
Measured: 3 days
Percentage of Time in Euglycemic Range - Phase 4
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4
Measured: 12 days
Percentage of Time in Euglycemic Range - Phase 6
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6
Measured: 7 days
Percentage of Time in Euglycemic Range - Phase 7
Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionOct 2016
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.
- Other trials for Type 1 DiabetesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subjects undergo treatment with the hybrid closed loop system under various experimental conditions
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lee, MD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857973
- Sponsor's protocol ID
- CEP273
- Acronym
- OCL
- Status last verified
- Oct 2018
- First submitted
- 15 May 2013
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
- ClinicalTrials.gov ID
- NCT01857973
- Acronym / sponsor ID
- OCL / CEP273
- Conditions
- Type 1 Diabetes
- Keywords
- HCL, Type 1 Diabetes, Sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
Detailed description
Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.
The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.
The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subjects undergo treatment with the hybrid closed loop system under various experimental conditions
| Arm | Type | Receives |
|---|---|---|
| Hybrid Closed Loop | Experimental | Device: Hybrid Closed LoopIn-clinic evaluation of the HCL System under various conditions. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 2-75 years of age at time of screening
- A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis
- Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
- Adequate venous access as assessed by investigator or appropriate staff
- Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hybrid Closed LoopThe Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose. | Device | Hybrid Closed Loop |
Primary outcome
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
Time frame: 12 days
time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.
7 secondary outcomes
Percentage of Time in Euglycemic Range - Exploratory A Phase
Time frame: 1 day
Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase
Time frame: 1 day
Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1
Time frame: 1 day
Percentage of Time in Euglycemic Range - Phase 2
Time frame: 3 days
Percentage of Time in Euglycemic Range - Phase 4
Time frame: 12 days
Percentage of Time in Euglycemic Range - Phase 6
Time frame: 7 days
Percentage of Time in Euglycemic Range - Phase 7
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Scott Lee, MD study director
Medtronic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Closed Loop in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 6 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 8 inclusion and 0 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 28 Feb 2019). 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?
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) (time frame: 12 days). 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 28 Feb 2019.