Type 1 DiabetesNCT04320069
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
A study of Type 1 Diabetes, run by Insulet Corporation at 4 sites in United States.
Trial summary
Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Jun 2020to 29 Sep 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at time of consent/assent 2-70 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
- Must be a current Omnipod user, or have used an Omnipod in the past
- Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
- Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
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- Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
- Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses
- Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses
- Willing to wear the system continuously throughout the study
- For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%
- Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App)
- Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
- 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 subjects aged < 18 years per State requirements.
- For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.
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 in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- Plans to receive blood transfusion over the course of the study
- Currently diagnosed with anorexia nervosa or bulimia
- Acute or chronic kidney disease or currently on hemodialysis
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- 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 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 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
- Clinical signs of hypothyroidism and 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)
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause.
- 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
Atlanta Diabetes
Atlanta, Georgia, 30318
University of Virginia
Charlottesville, Virginia, 22904
University of Colorado Denver
Denver, Colorado, 80045
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
Read the detailed description
The study schedule consists of two outpatient phases:
- 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by;
- 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2)
Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study.
Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator.
After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
- Conditions
- Type 1 Diabetes
- 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
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
| Study group | Role | What they receive |
|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Experimental | All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. 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.
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary outcomes (15)
Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-140 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Measured: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start9 Jun 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- This is a single-arm, multi-center, prospective clinical study.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordan Pinsker, MD, Study chair, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320069
- Sponsor's protocol ID
- G200018
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2020
- 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
Publications
Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O'Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment. Diabetes Technol Ther. 2022 Jan;24(1):18-25. doi: 10.1089/dia.2021.0140. Epub 2021 Sep 3.
PubMed 34491825
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
- Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04320069
- Acronym / sponsor ID
- G200018
- Conditions
- Type 1 Diabetes
- Keywords
- T1D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 24 Mar 2020 (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 use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
Detailed description
The study schedule consists of two outpatient phases:
- 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by;
- 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2)
Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study.
Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator.
After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
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 |
|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Experimental | Device: Omnipod Horizon™ Automated Glucose Control SystemAll subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. |
Who may qualify
- Ages
- 2 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 2-70 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
- Must be a current Omnipod user, or have used an Omnipod in the past
- Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
Key exclusion criteria (16 listed)
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- Plans to receive blood transfusion over the course of the study
- Currently diagnosed with anorexia nervosa or bulimia
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 SystemOmnipod Horizon™ Automated Glucose Control System use in Manual Mode | Device | Omnipod Horizon™ Automated Glucose Control System |
Primary outcome
Percentage of Time <70 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Glucose metric from continuous glucose monitoring system (CGM)
Percentage of Time >180 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Glucose metric from continuous glucose monitoring system (CGM)
15 secondary outcomes
Mean Glucose
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time <54 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 250 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time ≥ 300 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Percentage of Time in Range 70-180 mg/dL
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Mean Glucose
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <54 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time <70 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time >180 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 250 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time ≥ 300 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-180 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Percentage of Time in Range 70-140 mg/dL
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Standard Deviation
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Coefficient of Variation
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
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.
- Derived from this study: PubMed 34491825Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O'Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment. Diabetes Technol Ther. 2022 Jan;24(1):18-25. doi: 10.1089/dia.2021.0140. Epub 2021 Sep 3.
- 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.
Jordan Pinsker, MD study chair
Sansum Diabetes Research Institute
4 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, 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 15 inclusion and 16 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 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?
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?
Percentage of Time <70 mg/dL (time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)). 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?
On the ClinicalTrials.gov record for NCT04320069, which also lists 1 linked publication.
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.