Evaluation of Next Generation Sensors (Ngs) and Algorithm in Patients with Type 1 and Type 2 Diabetes
Sensor Study for Diabetes Patients
Viral Shah
Primary Investigator
Brief description of study
The purpose of this study is to collect data on the performance of sensor(s) each connected to/integrated with the transmitter(s) during 7-17 days of wear (approximately 170 to 410 hours) in subjects with type 1 or type 2 diabetes, 2-80 years of age.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
All subjects will be assigned to treatment for 7-17 days of sensor wear. Each subject will
wear between 1 and 4 sensors, and each will be connected to/integrated
with a transmitter.
Subjects 2-12 years of age will wear up to 2 study glucose sensors, subjects
13 years and older will wear up to 4 study glucose sensors. Sponsor will
inform the investigational center the specific details on the phase, study
design, type and number of sensors connected to the transmitters. Subjects
may not use SG values from the study devices for diabetes management.
Each subject will have study glucose sensors insertion and taping by the
trained investigational center staff in the abdomen, upper buttocks, upper
leg, or upper arm area. The subject and subject’s parent/guardian/caregiver
(if applicable) may be asked to insert and tape the study glucose sensors.
For all subjects, the subject’s parent/guardian/caregiver can assist in study
procedures and requirements.
During the study, each subject will undergo either 4 or 6 Frequent Sample
Testings (FSTs) obtained either by self-monitoring of blood glucose (SMBG)
from fingerstick from study meter BG readings and/or from venous testing
from an FDA approved blood glucose analyzer (BGA) (e.g., Yellow Springs
Instruments [YSI™*] or Nova Primary™*). Subject will be assigned to either
Phase 1, 2, or 3 Group.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes, Type 2 Diabetes
-
Age: 2 years - 80 years
-
Gender: All
Inclusion criteria
1. Age 2-80 years at time of screening.
2. Has a clinical diagnosis of type 1 or type 2 diabetes for 6 months or
more, as determined via medical record or source documentation by
an individual qualified to make a medical diagnosis.
3. Subject or parent(s)/guardian(s) is/are literate and able to read the
language offered in the study materials.
4. Agrees to comply with the CIP requirements.
5. Is willing to perform SMBG approximately every 15 minutes /20
minutes during FST.
6. If participating in BGA FST, has adequate venous access as assessed
by investigator or appropriate staff.
7. Subject and/or legally authorized representative is willing to provide
informed consent for participation.
8. Subject or parent(s)/guardian(s)/caregiver(s) is/are willing to
complete the requirements for diary data entry.
Exclusion Criteria
1. Requires a legally authorized representative to consent on their
behalf due to mental or intellectual disability.
2. For subjects 18 years and older, has history of allergy to
acetaminophen or has been told by health care provider they may
not ingest acetaminophen.
3. For subjects 18 years and older, reports history of liver cirrhosis or
liver problems such that a health care provider told them they should
not use acetaminophen because of liver disorder.
4. Has a history of allergy to dexamethasone or has been told by health
care provider they may not take any products containing
dexamethasone.
5. Will not tolerate tape adhesive in the area of sensor placement as
assessed by a qualified individual.
6. Has any unresolved adverse skin condition in the area of sensor or
device placement (e.g., psoriasis, dermatitis herpetiformis, rash,
Staphylococcus infection).
7. Is actively participating in an investigational study (drug or device)
wherein he/she has received treatment from an investigational study
drug or investigational study device in the last 2 weeks. (Please note
participation in an observational study is acceptable.)
8. Is 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).
9. Is currently abusing illicit drug(s).
10. Is currently abusing marijuana.
11. Is currently abusing prescription medication(s).
12. Is currently abusing alcohol.
13. Has a history of a seizure disorder.
14. If participating in BGA FST, has a hematocrit (Hct) of 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).
16. Is unwilling to participate in study procedures.
17. Has any other disease or condition that may preclude the patient
from participating in the study, per investigator judgment.
18. Is a member of the research staff involved with the study.
19. Is a Medtronic Diabetes employee or their immediate family member
(excluding adult children and/or adult siblings).
This study investigates the performance of sensors in people with Type 1 and Type 2 diabetes. Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels. Participants will wear sensors connected to transmitters for 7 to 17 days. The study involves people aged 2 to 80 years.
Participants will wear up to 4 sensors, depending on their age, which will be placed on areas like the abdomen or upper arm. During the study, participants will undergo Frequent Sample Testings (FSTs), where they will monitor their blood glucose levels using fingerstick tests or venous blood tests. The study will not use the sensor glucose values for diabetes management.
- Who can participate: People aged 2 to 80 years with Type 1 or Type 2 diabetes for at least 6 months can participate. Participants must be able to read study materials and agree to follow study requirements. They must also have adequate venous access if participating in blood glucose analyzer testing.
- Study details: Participants will wear sensors that are connected to transmitters for 7 to 17 days. They will perform Frequent Sample Testings (FSTs) using a blood glucose meter or analyzer. Participants will not use sensor data for managing their diabetes during the study.
