Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Detailed description
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days). This is a multi-center study.
Interventions
DEVICEContinuous Glucose Monitoring
CGM 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. Subject has a clinical diagnosis of type 1 or type 2 diabetes: 1. If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis. 2. If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis. 3. If subject is participating in YSI™\* FST , subject has 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 factor(s). Subjects without ratios may participate under observation only.
Exclusion criteria
1. Subject will not tolerate tape adhesive in the area of sensor 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 (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.) 4. Subject is female of child-bearing potential and has a pregnancy screening test that is positive. 5. Subject is a sexually active female of child-bearing potential and 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. If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of 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 \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data. |
Countries
China, United States
Participant flow
Pre-assignment details
317 subjects (175 adult subjects, 141 pediatric subjects, and 1 age-unknown subject) consented and enrolled in the overall study. Of them, 7 subjects were screening failure and 310 subjects (172 adult subjects and 138 pediatric subjects) participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Adult Subjects (Age 18-80) Wearing DS5 Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing | 172 |
| Pediatric Subjects (Age 2-17) Wearing DS5 Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing | 138 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Sponsor request | 1 | 0 |
| Overall Study | The sponsor was not able to provide the investigational product | 0 | 1 |
| Overall Study | Unsuccessful procedure | 0 | 1 |
| Overall Study | Withdrawal by parent/guardian | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
| Overall Study | Withdrawal due to Covid-19 | 8 | 1 |
Baseline characteristics
| Characteristic | Adult Subjects (Age 18-80) Wearing DS5 | Pediatric Subjects (Age 2-17) Wearing DS5 | Total |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 16.8 | 10.5 years STANDARD_DEVIATION 4.8 | 30.3 years STANDARD_DEVIATION 22 |
| BMI (kg/m2) | 28.7 kg/m^2 STANDARD_DEVIATION 6.4 | 19.8 kg/m^2 STANDARD_DEVIATION 4.2 | 24.8 kg/m^2 STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 10 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 106 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 54 Participants | 22 Participants | 76 Participants |
| Region of Enrollment China | 51 participants | 21 participants | 72 participants |
| Region of Enrollment United States | 121 participants | 117 participants | 238 participants |
| Sex: Female, Male Female | 78 Participants | 60 Participants | 138 Participants |
| Sex: Female, Male Male | 94 Participants | 78 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 172 | 0 / 138 |
| other Total, other adverse events | 27 / 172 | 23 / 138 |
| serious Total, serious adverse events | 1 / 172 | 0 / 138 |
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 \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
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) Wearing DS5 on the Arm | Percentage of Readings Within 20% Agreement | 88.9 percentage of readings |
| Pediatric Subjects (Age 2-17) Wearing DS5 on the Arm | Percentage of Readings Within 20% Agreement | 87.5 percentage of readings |
| Pediatric Subjects (Age 2-17) Wearing DS5 on the Buttock | Percentage of Readings Within 20% Agreement | 87.9 percentage of readings |
p-value: <0.0590% CI: [87.1, 90.7]ANCOVA
p-value: <0.0590% CI: [85.4, 89.7]ANCOVA
p-value: <0.0590% CI: [85.8, 89.9]ANCOVA