Type 1 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
Detailed description
The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
Interventions
DEVICEGuardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Individual is 2-80 years of age at time of consent. 2. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for: * at least the last 6 months for subjects 2-6 years of age * at least the last 12 months for subjects 7-80 years of age 3. Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and pen cartridge(s). 4. Subject is currently using or is willing to use the Guardian Connect system during the study. 5. Subject agrees to comply with the study protocol requirements. 6. For adult subjects: Subject is capable of providing legal consent without a legal authorized representative.
Exclusion criteria
1. Subject is using a syringe and unwilling or unable to use insulin pen(s). 2. Subject is using an insulin pump. 3. Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study. 4. Subject is using hydroxyurea at time of screening or plans to use it during the study. 5. Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider. 6. Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection). 7. Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device. 8. Subject has a positive urine pregnancy test at time of screening. 9. Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study. 10. Subject is unwilling to participate in study procedures. 11. Subject is directly involved in the study as research staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Hypoglycemia | Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2 | The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL) |
| Percentage of Time in Euglycemia | Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2 | The overall mean percentage of time in euglycemia (SG 70-180 mg/dL) |
| Percentage of Time in Hyperglycemia | Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2 | The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL) |
Countries
United States
Participant flow
Recruitment details
All subjects participated for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older participated for up to 9 months (Phase 2). All subjects wore the Guardian Connect system (real-time CGM) continuously and used smart insulin pens or insulin pens with smart caps for multiple daily injections and continued their standard therapy throughout the duration of the study.
Participants by arm
| Arm | Count |
|---|---|
| Guardian™ Connect System, InPen™ Basal Smart Cap, and Smart Insulin Pens All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app: Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI. | 208 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase 1 | Lost to Follow-up | 6 |
| Phase 1 | Physician Decision | 3 |
| Phase 1 | Protocol Violation | 2 |
| Phase 1 | Withdrawal by Subject | 29 |
| Phase 2 | Protocol Violation | 3 |
| Phase 2 | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Guardian™ Connect System, InPen™ Basal Smart Cap, and Smart Insulin Pens |
|---|---|
| Age, Continuous | 37.3 Years STANDARD_DEVIATION 17.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native, Black or African American, White | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native, White | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 13 Participants |
| Race/Ethnicity, Customized Race Black or African American | 28 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants |
| Race/Ethnicity, Customized Race White | 154 Participants |
| Region of Enrollment United States | 208 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 208 | 0 / 67 |
| other Total, other adverse events | 20 / 208 | 0 / 67 |
| serious Total, serious adverse events | 5 / 208 | 3 / 67 |
Outcome results
Primary
Percentage of Time in Euglycemia
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Population: The number of participants analyzed reflects the number of subjects for which any data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 | Percentage of Time in Euglycemia | 59.5 percentage of time | Standard Deviation 20.2 |
| Phase 2 | Percentage of Time in Euglycemia | 58.7 percentage of time | Standard Deviation 20 |
Primary
Percentage of Time in Hyperglycemia
The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL)
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Population: The number of participants analyzed reflects the number of subjects for which any data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 | Percentage of Time in Hyperglycemia | 37.5 percentage of time | Standard Deviation 20.9 |
| Phase 2 | Percentage of Time in Hyperglycemia | 38.7 percentage of time | Standard Deviation 20.7 |
Primary
Percentage of Time in Hypoglycemia
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Population: The number of participants analyzed reflects the number of subjects for which any data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 | Percentage of Time in Hypoglycemia | 3.1 percentage of time | Standard Deviation 3.4 |
| Phase 2 | Percentage of Time in Hypoglycemia | 2.7 percentage of time | Standard Deviation 3.3 |