Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Omnipod Horizon™ Automated Glucose Control System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omnipod Horizon™ Automated Glucose Control System<br>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. | Device: Omnipod Horizon™ Automated Glucose Control System<br>* Omnipod Horizon™ Automated Glucose Control System use in Manual Mode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | 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) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | 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) | 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) | 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) | 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) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | 
| Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1D, Omnipod