Type 1 DiabetesNCT02897557
Insulet Artificial Pancreas Early Feasibility Study
A study testing Insulet Artificial Pancreas (AP) System in people with Type 1 Diabetes, run by Insulet Corporation at 4 sites in United States.
Trial summary
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and… Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulet Artificial Pancreas (AP) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2016to Mar 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
- Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
- Willing to use the study CGM device for one week prior to study start and for the duration of the study
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- Willing to use the OmniPod® Insulin Management System during the study
- Willing to perform all SMBG 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 refrain from use of acetaminophen, pseudoephedrine, 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 or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- 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 or more "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
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- 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 wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor on the abdomen
- Known history of myocardial infarction (MI) or stroke within the past 6 months
- 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
- 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 testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
- Unable to follow 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
4 sites in 1 country.
United States4 sites
University of Colorado Denver
Denver, Colorado, 80045
Stanford University
Palo Alto, California, 94305
William Sansum Diabetes Center
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulet Artificial Pancreas (AP) System
- 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 Artificial Pancreas (AP) SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort in CRC | Experimental | This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. Receives: Device: Insulet Artificial Pancreas (AP) 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: 36 hours
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
Measured: 36 hours
Secondary outcomes (8)
Mean glucose
Measured: 36 hours
Percentage of time < 50 mg/dL
Measured: 36 hours
Percentage of time < 60 mg/dL
Measured: 36 hours
Percentage of time > 180 mg/dL
Measured: 36 hours
Percentage of time >/= 300 mg/dL
Measured: 36 hours
Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)
Measured: 36 hours
Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)
Measured: 36 hours
Standard deviation and coefficient of variation of CGM values
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT02897557
- Sponsor's protocol ID
- AP-IDE #1 and 1a
- Status last verified
- Apr 2021
- First submitted
- 1 Sep 2016
- Last updated
- 9 Apr 2021
- 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
- ClinicalTrials.gov ID
- NCT02897557
- Acronym / sponsor ID
- AP-IDE #1 and 1a
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Sep 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 purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort in CRC | Experimental | Device: Insulet Artificial Pancreas (AP) SystemThis study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
- Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
- Willing to use the study CGM device for one week prior to study start and for the duration of the study
Key exclusion criteria (22 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 or more "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 Artificial Pancreas (AP) System | Device | Single Cohort in CRC |
Primary outcome
Percentage of time in hypoglycemic range (defined as <70 mg/dL)
Time frame: 36 hours
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
Time frame: 36 hours
8 secondary outcomes
Mean glucose
Time frame: 36 hours
Percentage of time < 50 mg/dL
Time frame: 36 hours
Percentage of time < 60 mg/dL
Time frame: 36 hours
Percentage of time > 180 mg/dL
Time frame: 36 hours
Percentage of time >/= 300 mg/dL
Time frame: 36 hours
Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)
Time frame: 36 hours
Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)
Time frame: 36 hours
Standard deviation and coefficient of variation of CGM values
Time frame: 36 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 9 Apr 2021.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulet Artificial Pancreas (AP) System in people with Type 1 Diabetes, run by Insulet Corporation at 4 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 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: 36 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 9 Apr 2021.