Type 1 Diabetes MellitusNCT04176731
Prepivotal Omnipod Horizon™ Automated Glucose Control System
A study of Type 1 Diabetes Mellitus, run by Insulet Corporation at 6 sites in United States.
Trial summary
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Dec 2019to 31 Jan 2020
- 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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent/assent 6-70 years
- Subjects aged < 18 years must be living with parent/legal guardian
- Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
- Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
- Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog, or Apidra during the study
Show all 15Show fewer
- Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase
- Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria
- Willing to wear the system continuously throughout the study
- A1C <10% at screening visit
- Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
- Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
- Able to read and speak English fluently
- Subject must be in an AT\&T covered area
- 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 aged < 18 years per State requirements.
Who cannot join
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months
- History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with sickle cell disease
- Diagnosed with hemophilia or any other bleeding disorders
- Plans to receive blood transfusion over the course of the study
Show all 19Show fewer
- Currently diagnosed with anorexia nervosa or bulimia
- Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
- History of adrenal insufficiency
- Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the course of the study
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
- Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
- 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.
- For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- 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)
- Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the study period
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Atlanta Diabetes
Atlanta, Georgia, 30318
University of Virginia
Charlottesville, Virginia, 22904
University of Colorado Denver
Denver, Colorado, 80045
Mount Sinai
New York, New York, 10029
Stanford University
Palo Alto, California, 94305
International Diabetes Center
Saint Louis Park, Minnesota, 55416
About this study
Official title: Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Read the detailed description
The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.
Subjects will undergo a 14-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 continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting.
The hybrid closed-loop phase will begin on Study Day 1.
During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days.
During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges.
After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Omnipod Horizon™ 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.
Omnipod Horizon™ Automated Glucose Control SystemDevice
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm Receives: Device: Omnipod Horizon™ Automated Glucose Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Severe Hypoglycemia
Measure of serious device-related adverse events
Measured: hybrid closed-loop (14 days)
Proportion of Subjects With Diabetic Ketoacidosis (DKA)
Measure of serious device-related adverse events
Measured: hybrid closed-loop (14 days)
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Measured: hybrid closed-loop (9 days) compared to standard therapy (14 days)
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Measured: hybrid closed-loop (5 days) compared to standard therapy (14 days)
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Measured: hybrid closed-loop (14 days) compared to standard therapy (14 days)
Secondary outcomes (15)
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Time in Range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time ≥250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time ≥300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time <70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time <54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Standard Deviation of Glucose (mg/dL)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Measurement of glucose management using overall glucose averages
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage
Measured: hybrid closed-loop (14 days)
Total Daily Insulin (TDI) (Units, Units/kg)
Measure of insulin requirements
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Total Daily Basal Insulin (Units, Units/kg)
Measure of insulin requirements
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Total Daily Bolus Insulin (Units, Units/kg)
Measure of insulin requirements
Measured: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start15 Dec 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, multi-center, prospective clinical study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Buckingham, MD, Study chair, Stanford UniversitySue Brown, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176731
- Sponsor's protocol ID
- Horizon™ Prepivotal Study
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2019
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04176731
- Acronym / sponsor ID
- Horizon™ Prepivotal Study
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 13 Nov 2023
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 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Detailed description
The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.
Subjects will undergo a 14-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 continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting.
The hybrid closed-loop phase will begin on Study Day 1.
During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days.
During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges.
After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, multi-center, prospective clinical study.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Omnipod Horizon™ Automated Glucose Control SystemAll subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age at time of consent/assent 6-70 years
- Subjects aged < 18 years must be living with parent/legal guardian
- Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
- Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
Key exclusion criteria (19 listed)
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months
- History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with sickle cell disease
- Diagnosed with hemophilia or any other bleeding disorders
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 |
|---|---|---|
| Omnipod Horizon™ Automated Glucose Control SystemThe Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery | Device | Treatment |
Primary outcome
Proportion of Subjects With Severe Hypoglycemia
Time frame: hybrid closed-loop (14 days)
Measure of serious device-related adverse events
Proportion of Subjects With Diabetic Ketoacidosis (DKA)
Time frame: hybrid closed-loop (14 days)
Measure of serious device-related adverse events
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Time frame: hybrid closed-loop (9 days) compared to standard therapy (14 days)
Percentage of time in range 70-180 mg/dL
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Time frame: hybrid closed-loop (5 days) compared to standard therapy (14 days)
Percentage of time in range 70-180 mg/dL
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Time frame: hybrid closed-loop (14 days) compared to standard therapy (14 days)
Percentage of time in range 70-180 mg/dL
15 secondary outcomes
Mean Glucose
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Time in Range 70-180 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Time in Range 70-140 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time >180 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time ≥250 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time ≥300 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time <70 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Percentage of Time <54 mg/dL
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Standard Deviation of Glucose (mg/dL)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Coefficient of Variation
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Time frame: hybrid closed-loop (14 days)
Total Daily Insulin (TDI) (Units, Units/kg)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Total Daily Basal Insulin (Units, Units/kg)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Total Daily Bolus Insulin (Units, Units/kg)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
Bruce Buckingham, MD study chair
Stanford University
Sue Brown, MD study chair
University of Virginia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus, run by Insulet Corporation 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 15 inclusion and 19 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 13 Nov 2023. 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 13 Nov 2023). 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?
Proportion of Subjects With Severe Hypoglycemia (time frame: hybrid closed-loop (14 days)). The study lists 5 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 13 Nov 2023.