Protocol Flashcards
Indication under investigation
Type 1 and Type 2 diabetes
Investigational and non-investigational products
Investigational:
- Disposable Sensor (labeled as DS5)
- Synergy Download Utility Software
Non-Investigational:
- CareLink System software
- Blue Bluetooth Low Energy adapter
- Ascensia Contour NEXT LINK 2.4 Blood Glucose meter (to be obsoleted - may need to remove)
- Roche Accu-Chek Guide Meter
- I-SENS KetoSens meter or other approved ketone meter
- OTC tape(s) if needed (e.g., Hypafix)
- Test strips, control solution, lancing device, lancets, Skin Tac adhesives, and alcohol swabs (listed in table in protocol).
Purpose of the study
To collect data on the performance of sensor(s) during 7-17 days of wear (approximately 170-410 hours) in subjects with type 1 or type 2 diabetes, 11-80 years of age.
Objective of the study
To collect data to be used for development of sensors.
How many days of sensor wear?
7-17 days.
Max time in the study will be ~47 days (including replacement sensor wear and repeat of office procedure if needed). 30 day max to complete V2 + 17 max sensor wear.
How many sensors will be worn?
Between 1 and 4 sensors.
Sponsor will inform site of the number of sensors.
Who may insert and tape sensors?
Subject
Subject’s parent/guardian/caregiver (if applicable)
Site
Where are the sensors worn?
11-17 y.o.: arm and buttock
18-80 y.o.: arm and abdomen
How many SMBGs per day with the study meter?
6-8 SMBGs throughout the day.
Recommended times:
- After exercise
- Prior to meals
- At bedtime
- Symptoms of hypoglycemia or hyperglycemia
Sponsor will inform the site of the specific details on SMBG collection.
How many FSTs and challenges?
11-13 y.o.: 2 FSTs for 6 hours each.
- one hypoglycemia challenge
- one hyperglycemic challenge
14-80 y.o: 4 FSTs for 8 hours each.
- two hypoglycemic challenges
- two hyperglycemic challenges
FSTs will be at a minimum of 24 hours apart.
Subjects who do not have relatively stable insulin dosing parameters for at least one month and insulin use for at least 3 months may continue in the FST under observation only.
Sponsor will provide guidance on FST days.
How frequently are samples drawn during the FST?
Every 5-15 minutes.
Depends on the value of the previous sample:
- < 70 mg/dL; every 5 minutes (window 3-8 minutes)
- >/= 70 mg/dL to </= 180 mg/dL: every 15 minutes (window 13-18 minutes)
- > 180 mg/dL; every 5 minutes (window 3-8 minutes)
What is the max blood volume that can be drawn?
11-17 y.o.: No more than 5 mL/kg in a 24-hour period, and no more than 9.5 mL/kg (inclusive of all FST days) over any 8-week period.
18-80 y.o.: No more than 5 mL/kg in a 24-hour period, and no more than 10.5 mL/kg (inclusive of all FST days) or 550 mL, whichever is smaller, over any 8-week period.
Note: The time of the 24-hour blood draw limit begins at the start of the first blood draw of an FST and ends 24 hours after that.
Explain hypoglycemic and hyperglycemic challenges.
Subjects will need to meet the following prior to participating in challenges:
(1) Has been using insulin for at least 3 months
(2) Per investigator assessment, must have relatively stable insulin carbohydrate ratio(s) and insulin sensitivity factor(s) for at least one month
Investigator discretion may be used in selecting which challenge is to be performed for each FST as long as the frequency of challenges are met.
Sponsor will provide guidance on challenges.
Discuss hypoglycemic challenges.
Goal is to maintain the subject in a range of < 70 mg/dL for ~2 hours and within those 2 hours, target 15 minutes in the 50-60 mg/dL range.
When <70 mg/dL, a clinical symptom check should be done with every FST sample.
Insulin dose may be calculated by using the subject’s own insulin sensitivity factor/correction factor, the subject’s starting BG, and a target BG of 65 mg/dL. Insulin may be administered more than once per investigator discretion; however, at least 3 hours should occur between each insulin dose. If there is less than 3 hours between each insulin dose, then subsequent insulin dose should be reduced per investigator discretion to reduce risk of insulin stacking.
After challenge completion, observation target glucose should be 100-150 mg/dL. Subject may eat and take insulin per investigator discretion.
Discuss hyperglycemic challenges.
Goal is to maintain the subject in a range of 180-400 mg/dL for ~2.5 hours and within those 2.5 hours, target 30 minutes in the 350-400 mg/dL range.
When >300 mg/dL or when ketones are >0.6 mmol/L, a clinical symptom check should be done every 30 minutes.
After challenge completion, observation target glucose should be 100-150 mg/dL. Subject may eat and take insulin per investigator discretion.
Explain food intake, medication management, and glucose target during the study.
Investigator discretion and/or sponsor guidelines may be used to manage insulin, medication, diabetes management, and meals. Sponsor will provide guidance.
The above also includes during the FST and during challenges.
Sample size and number of sites
Up to 1,500 subjects
Up to 20 sites
Can subjects repeat?
Yes, subjects may repeat participation 8 weeks following their last exit from the study at the investigator’s and sponsor’s discretion based on previous participation (under a new subject ID) as long as the max blood volume guidelines are adhered to.
Subjects cannot repeat at a different site.
How long is the study?
~36 months from first site initiation to study completion.
How long must a subject have a type 1 or type 2 diabetes diagnosis in order to participate?
6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
What exclusion criteria list within “the past 6 months prior to screening?”
- DKA
- severe hypoglycemia
- hypoglycemic seizure
- hypoglycemia resulting in loss of consciousness
What labs are collected in the study?
(1) Hematocrit (cannot be >10% below the lower limit of the normal reference range); may use prior blood draw from routine care if done within 6 months of screening and report of lab is placed in subject’s source documents)..
(2) Pregnancy test for women of childbearing potential. Point-of-care.
Both completed at screening visit only.
How many planned study visits?
11-13 y.o.: 6 visits
14-80 y.o.: 10 visits
What is the window between visit 1 and visit 2?
Visit 1 to Visit 2 must be completed in 30 days.
V1 and V2 can be combined if eligibility is met (e.g., Hct value confirmed).
When is the first FST?
Visit 3
Explain the follow-up phone calls.
The site will follow-up with the subject after each FST within 24-hours from discharge to address any questions, concerns, and ask questions (e.g., most recent BG reading, ketone testing (as applicable), and assessing for AEs).
