Type 1 Diabetes MellitusIDE2NCT03064906
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
A study testing Insulet AP (artificial pancreas) System in people with Type 1 Diabetes Mellitus, run by Insulet Corporation at 3 sites in United States.
Trial summary
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulet AP (artificial pancreas) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2017to 7 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at time of consent 18.0 to 65.0 years
- Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
- Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
- Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 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
- Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
- Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
- 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)
Who cannot join
- A1C >10% at the screening visit
- One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
- One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- Used non-insulin anti-diabetic medication within last 30 days
- 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)
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- Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
- Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
- Currently undergoing systemic treatment with steroids or immunosuppressive medication
- Current illness that would interfere with participation in the study
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Denver
Denver, Colorado, 80045
Stanford University
Palo Alto, California, 94305
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
Read the detailed description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulet AP (artificial pancreas) 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 AP (artificial pancreas) SystemDevice
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Meal Performance and/or Exercise | Other | This study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system.
Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions. Receives: Device: Insulet AP (artificial pancreas) 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: 54 hours
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Measured: 54 hours
Secondary outcomes (14)
Mean glucose
Measured: 54 hours
Percentage of time < 50 mg/dL
Measured: 54 hours
Percentage of time < 60 mg/dL
Measured: 54 hours
Percentage of time > 180 mg/dL
Measured: 54 hours
Percentage of time ≥ 300 mg/dL
Measured: 54 hours
Percentage of time between 70-180 mg/dL
Measured: 54 hours
Percentage of time between 70-140 mg/dL
Measured: 54 hours
Standard deviation
Measured: 54 hours
Coefficient of variation
Measured: 54 hours
Meal challenge-12 hour PPG dinner
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.
Measured: 54 hours
Meal challenge-4 hour PPG breakfast
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.
Measured: 54 hours
Meal challenge-4 hour PPG lunch
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.
Measured: 54 hour
Exercise challenge-immediate and delayed glucose response
The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.
Measured: 54 hour
Effect of changing setpoints
Effect of changing setpoints to overall performance.
Measured: 54 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start18 Mar 2017
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03064906
- Sponsor's protocol ID
- IDE2
- Acronym
- IDE2
- Status last verified
- Jun 2018
- First submitted
- 22 Feb 2017
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
- ClinicalTrials.gov ID
- NCT03064906
- Acronym / sponsor ID
- IDE2 / IDE2
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2017 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 27 Feb 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.
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
Detailed description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
| Arm | Type | Receives |
|---|---|---|
| Meal Performance and/or Exercise | Other | Device: Insulet AP (artificial pancreas) SystemThis study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system. Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age at time of consent 18.0 to 65.0 years
- Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
- Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
- Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
- Willing to use the study CGM device for the duration of the study
Key exclusion criteria (12 listed)
- A1C >10% at the screening visit
- One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
- One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- Used non-insulin anti-diabetic medication within last 30 days
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 AP (artificial pancreas) SystemInsulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm. | Device | Meal Performance and/or Exercise |
Primary outcome
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time frame: 54 hours
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Time frame: 54 hours
14 secondary outcomes
Mean glucose
Time frame: 54 hours
Percentage of time < 50 mg/dL
Time frame: 54 hours
Percentage of time < 60 mg/dL
Time frame: 54 hours
Percentage of time > 180 mg/dL
Time frame: 54 hours
Percentage of time ≥ 300 mg/dL
Time frame: 54 hours
Percentage of time between 70-180 mg/dL
Time frame: 54 hours
Percentage of time between 70-140 mg/dL
Time frame: 54 hours
Standard deviation
Time frame: 54 hours
Coefficient of variation
Time frame: 54 hours
Meal challenge-12 hour PPG dinner
Time frame: 54 hours
Meal challenge-4 hour PPG breakfast
Time frame: 54 hours
Meal challenge-4 hour PPG lunch
Time frame: 54 hour
Exercise challenge-immediate and delayed glucose response
Time frame: 54 hour
Effect of changing setpoints
Time frame: 54 hour
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 12 Jun 2018.
- 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 testing Insulet AP (artificial pancreas) System in people with Type 1 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 11 inclusion and 12 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 12 Jun 2018. 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: 54 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 12 Jun 2018.