Type1 Diabetes MellitusNCT03216460
Insulet Artificial Pancreas Free-Living IDE3
A study of Type1 Diabetes Mellitus, run by Insulet Corporation at 3 sites in United States.
Trial summary
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Feb 2019to 28 May 2019
- 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 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent 2.0-85 years
- Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
- A1C <10% at screening
- Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 months prior to study start
- Willing to use the study CGM device for the duration of the study
- Willing to use the Omnipod® Insulin Management System during the study
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- Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol or per investigator discretion
- Willing to participate in setpoint and meal challenges
- Willing to use carbohydrate counting for determination of meal boluses
- Willing to participate in moderate intensity exercise for at least 30 minutes per day
- Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects per State requirements.
Who cannot join
- One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
- Using a basal insulin with a usual duration of insulin action > 36 hours
- Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
- Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
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- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. Abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QT interval (> 440 ms). Electrocardiogram is only required for subjects >50 years old or with diabetes duration >20 years.
- Stroke
- Known history of seizure disorder
- Known history of adrenal insufficiency
- Current renal or hepatic disease
- Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
- Currently undergoing cancer treatment
- Currently undergoing systemic treatment with steroids or immunosuppressive medication
- Known history of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
- Current illness that would interfere with participation in the study
- Untreated or inadequately treated mental illness
- Current alcohol abuse per investigator's judgment
- Electrically-powered implants that may be susceptible to RF interference
- Currently participating in another clinical study using an investigational drug or device
- Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
- Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Denver
Denver, Colorado, 80045
Yale University School of Medicine
New Haven, Connecticut, 06511
Stanford University
Palo Alto, California, 94305
About this study
Official title: Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
Read the detailed description
The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase.
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
The hybrid closed-loop phase will begin prior to lunch on Study Day 1.
During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise.
Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Insulet automated glucose control system
- Keywords
- T1D, Omnipod
- 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.
Insulet automated glucose control systemDevice
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Free-Living | Other | Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting, where subjects will participate in specific setpoint challenges, meal challenges, and exercise Receives: Device: Insulet automated glucose control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Measured: 96 hours
Percentage of time in hyperglycemic range (defined as ≥ 250 mg/dL)
Measured: 96 hours
Secondary outcomes (10)
Mean Glucose
Measured: 96 hours
Percentage of time < 50 mg/dL
Measured: 96 hours
Percentage of time < 54 mg/dL
Measured: 96 hours
Percentage of time < 60 mg/dL
Measured: 96 hours
Percentage of time > 180 mg/dL
Measured: 96 hours
Percentage of time ≥ 300 mg/dL
Measured: 96 hours
Percentage of time between 70-180 mg/dL
Measured: 96 hours
Percentage of time between 70-140 mg/dL
Measured: 96 hours
Standard deviation
Using CGM measurements, the Standard deviations will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h).
Measured: 96 hours
Coefficient of variation
Using CGM measurements, the Coefficient of variation will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h).
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start4 Feb 2019
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm, multi-center, observational clinical study.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216460
- Sponsor's protocol ID
- IDE3
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3
- ClinicalTrials.gov ID
- NCT03216460
- Acronym / sponsor ID
- IDE3
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- T1D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 13 Jul 2017 (actual)
- 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.
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
Detailed description
The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase.
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
The hybrid closed-loop phase will begin prior to lunch on Study Day 1.
During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise.
Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm, multi-center, observational clinical study.
| Arm | Type | Receives |
|---|---|---|
| Supervised Free-Living | Other | Device: Insulet automated glucose control systemSubjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting, where subjects will participate in specific setpoint challenges, meal challenges, and exercise |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age at time of consent 2.0-85 years
- Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
- A1C <10% at screening
- Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 months prior to study start
- Willing to use the study CGM device for the duration of the study
Key exclusion criteria (22 listed)
- One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
- Using a basal insulin with a usual duration of insulin action > 36 hours
- Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
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 |
|---|---|---|
| Insulet automated glucose control systemInsulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm. | Device | Supervised Free-Living |
Primary outcome
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time frame: 96 hours
Percentage of time in hyperglycemic range (defined as ≥ 250 mg/dL)
Time frame: 96 hours
10 secondary outcomes
Mean Glucose
Time frame: 96 hours
Percentage of time < 50 mg/dL
Time frame: 96 hours
Percentage of time < 54 mg/dL
Time frame: 96 hours
Percentage of time < 60 mg/dL
Time frame: 96 hours
Percentage of time > 180 mg/dL
Time frame: 96 hours
Percentage of time ≥ 300 mg/dL
Time frame: 96 hours
Percentage of time between 70-180 mg/dL
Time frame: 96 hours
Percentage of time between 70-140 mg/dL
Time frame: 96 hours
Standard deviation
Time frame: 96 hours
Coefficient of variation
Time frame: 96 hours
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 2 Aug 2019.
- 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.
Bruce Buckingham, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type1 Diabetes Mellitus, run by Insulet Corporation at 3 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 22 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Percentage of time in hypoglycemic range (defined as < 70 mg/dL) (time frame: 96 hours). 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?
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 2 Aug 2019.