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Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.
Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.
This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.
Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.
Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.
Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator | Omnipod 5 System with Dexcom G6 continuous glucose monitoring system |
|
| Control Arm | No Intervention | Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod 5 System | Device | Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group during the 13-week study phase |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time <54 mg/dL (Non-inferiority) | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase |
| Percent of Time >180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Weinstock, MD | State University of New York - Upstate Medical University | Study Chair |
| Eric Renard, Pr | Lapeyronie Montpellier University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States | ||
| Sansum Diabetes Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Omnipod 5 System with Dexcom G6 continuous glucose monitoring system Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes. |
| FG001 | Control Arm | Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Omnipod 5 System with Dexcom G6 continuous glucose monitoring system Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes. |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Time in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | Subjects are included in the Primary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | Percentage of time | Comparing intervention group with control group during the 13-week study phase |
|
Start time of the standard therapy (14-days prior to Study Day 1) and continued until the participant's participation ended, up to 13 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Omnipod 5 System with Dexcom G6 continuous glucose monitoring system Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Injury, poisoning and procedural complications | Systematic Assessment | Tibia fracture requiring surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Investigations | Systematic Assessment | The 'other' events in the Omnipod 5 System group included concussion, lumbosciatica, pneumonia, shoulder pain, skin reaction and angina. The 'other' events in the Control group included laryngitis, fibula fracture, foot fracture and sciatica. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Trang Ly | Insulet Corporation | 9786007628 | tly@insulet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2022 | Oct 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2023 | Nov 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Glucose metric from study continuous glucose monitoring system
| Comparing intervention group with control group at the end of the 13-week study phase |
| Mean Glucose | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase |
| Change in HbA1c | Measures device effectiveness | Baseline compared to end of study visit (Day -30 to Day 90) |
| Percent of Time <70 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase |
| Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | Baseline compared to end of study visit (Day -14 to Day 90) |
| Change in Hypoglycemic Confidence Scale (HCS) Total Score | A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | Baseline compared to end of study visit (Day -14 to Day 90) |
| Change in Diabetes Quality of Life (DQOL)-Brief Total Score | A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome. | Baseline compared to end of study visit (Day -14 to Day 90) |
| Proportion of Participants With T1-DDS MCID After 13 Weeks | Proportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups | Comparing intervention group with control group at the end of the 13-week study phase |
| Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks | Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks | Comparing intervention group with control group at the end of the 13-week study phase |
| Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks | Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5 | Comparing intervention group with control group at the end of the 13-week study phase |
| Santa Barbara |
| California |
| 93105 |
| United States |
| University of Colorado Denver | Denver | Colorado | 80045 | United States |
| Atlanta Diabetes | Atlanta | Georgia | 30318 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| State University of New York, Upstate Medical University | Syracuse | New York | 13244 | United States |
| Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic) | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Hopital Sud-Francilien | Corbeil-Essonnes | France |
| Hospices Civils de Lyon - Centre du diabete Diab-eCare | Lyon | France |
| CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition | Montpellier | France |
| Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications | Paris | France |
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Due to privacy laws, race and ethnicity were reported by participants in the U.S. only. Two participants identified as "Other race", so their results are included in the "Unknown or Not Reported" row. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (kg/m^2) | Mean | Standard Deviation | (kg/m^2) |
|
| HbA1c at Screening | Mean | Standard Deviation | Percentage |
|
| HbA1c ≥ 8% | Count of Participants | Participants |
|
| Daily Insulin Dose | Mean | Standard Deviation | units/kg |
|
| Previous or Current CGM Use | Count of Participants | Participants |
|
| Duration of Insulin Pump Use | Mean | Standard Deviation | years |
|
|
|
| Secondary | Percent of Time <54 mg/dL (Non-inferiority) | Glucose metric from study continuous glucose monitoring system | Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | Percentage of time | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Percent of Time >180 mg/dL | Glucose metric from study continuous glucose monitoring system | Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | Percentage of time | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Mean Glucose | Glucose metric from study continuous glucose monitoring system | Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | mg/dL | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Change in HbA1c | Measures device effectiveness | Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | percentage of HbA1C | Baseline compared to end of study visit (Day -30 to Day 90) |
|
|
|
| Secondary | Percent of Time <70 mg/dL | Glucose metric from study continuous glucose monitoring system | Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing. | Posted | Mean | Standard Deviation | Percentage of time | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline compared to end of study visit (Day -14 to Day 90) |
|
|
|
| Secondary | Change in Hypoglycemic Confidence Scale (HCS) Total Score | A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline compared to end of study visit (Day -14 to Day 90) |
|
|
|
| Secondary | Change in Diabetes Quality of Life (DQOL)-Brief Total Score | A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline compared to end of study visit (Day -14 to Day 90) |
|
|
|
| Secondary | Proportion of Participants With T1-DDS MCID After 13 Weeks | Proportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups | Posted | Count of Participants | Participants | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks | Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks | Posted | Count of Participants | Participants | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| Secondary | Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks | Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5 | Posted | Count of Participants | Participants | Comparing intervention group with control group at the end of the 13-week study phase |
|
|
|
| 0 |
| 132 |
| 1 |
| 132 |
| 11 |
| 132 |
| EG001 | Control Arm | Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system | 0 | 62 | 1 | 62 | 8 | 62 |
|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
|
| Prolonged Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 13 Weeks |
|
|
| 13 Weeks |
|
|
| 13 Weeks |
|
|
| 13 Weeks |
|
|