Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Detailed description
The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Interventions
DEVICEGuardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Continuous Glucose Monitoring and frequent sample testing
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 enrollment 2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. Adequate venous access as assessed by investigator or appropriate staff 4. Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only
Exclusion criteria
1. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual. 2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. Subject is female and has a positive pregnancy screening test 5. Female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator 6. Subject is female and plans to become pregnant during the course of the study 7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment 8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment. 9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment. 10. Subject has a history of a seizure disorder 11. Subject has central nervous system or cardiac disorder resulting in syncope 12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease 13. Subject has a hematocrit (Hct) lower than the normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents) 14. Subject has a history of adrenal insufficiency 15. Subject is a member of the research staff involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Readings Within 20% Agreement | 7 days (170 hours) | Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. |
Countries
United States
Participant flow
Pre-assignment details
335 subjects (188 adult subjects and 147 pediatric subjects) consented and enrolled in the overall study. Of them, 311 subjects (169 adult subjects and 142 pediatric subjects) were eligible.
Participants by arm
| Arm | Count |
|---|---|
| Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing | 169 |
| Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing | 142 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Unable to complete study visits due to COVID-19 | 0 | 13 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) | Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) | Total |
|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 17.8 | 10.9 years STANDARD_DEVIATION 4 | 29.9 years STANDARD_DEVIATION 22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 17 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants | 125 Participants | 273 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 169 participants | 142 participants | 311 participants |
| Sex: Female, Male Female | 91 Participants | 59 Participants | 150 Participants |
| Sex: Female, Male Male | 78 Participants | 83 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 169 | 0 / 142 |
| other Total, other adverse events | 37 / 169 | 32 / 142 |
| serious Total, serious adverse events | 2 / 169 | 2 / 142 |
Outcome results
Primary
Percentage of Readings Within 20% Agreement
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
Time frame: 7 days (170 hours)
Population: Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm | Percentage of Readings Within 20% Agreement | 88.00 Percentage of Readings |
| Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen | Percentage of Readings Within 20% Agreement | 87.96 Percentage of Readings |
| Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm | Percentage of Readings Within 20% Agreement | 84.59 Percentage of Readings |
| Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Buttock | Percentage of Readings Within 20% Agreement | 81.05 Percentage of Readings |
p-value: <0.04191.8% CI: [86.05, 89.95]ANCOVA
p-value: <0.04191.8% CI: [86.13, 89.8]ANCOVA
p-value: 0.04191.8% CI: [82.02, 87.17]ANCOVA
p-value: <0.04191.8% CI: [77.58, 84.53]ANCOVA