Eligibility |
1. Be at least 8 years old
2. Have type 1 diabetes
3. Have used insulin at least one year
4. Use an insulin pump or multiple daily
injections of insulin (at least 3 shots per day)
Your insulin regimen must have been stable for at least the last two months and you must have no plans to switch how you take your insulin during the next 6 months (e.g., if you are using multiple daily injections, you will be asked to not switch to an insulin pump during the next 6 months)
5. Have a HbA1C level of 10.0% or lower. This will be measured at the time of enrollment.
6. Speak and read English (for minors both the subject and parent or guardian must meet this criteria)
7. Not have plans to move out of this
area in the next 12 months
8. Have not been part of another research
study evaluating a treatment in the last six weeks
9. Have not used real-time continuous
glucose monitor at home in the last 6 months
10. Be willing to use only the home glucose
meter provided by the study for blood sugar testing
11. If you are female, not be pregnant
or intending to become pregnant during the next year
12. Not have a medical problem or current
use of medications that your doctor feels will be a problem
13. No inpatient psychiatric treatment
within the past 6 months (for minors this refers to the subject and
the parent or guardian)
14. No other members of the participants
household is participating in the study
15. Be willing to follow the procedures
that will be described in the next section
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Procedures |
Enrollment visit:
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answer questionnaires
-
a HbA1c will be drawn by fingerstick
- become oridented to the
RT-CGM systems and together you will choose the system that seems
best for you. You will be taught to use the real-time continuous glucose monitor. The first sensor will
be inserted by you with guidance from the study team. During the
first week, the real-time continuous glucose monitor system will be blinded, meaning you will not
be able to see the results from the real-time continuous glucose monitor.
Baseline visit: scheduled approximately 7-13 days after the first
visit.
- Clinic staff will download the real-time continuous glucose monitor and the home glucose
meter.
- HbA1c measurements will be collected by fingerstick.
-
A computer program
will assign you by chance to either get the real-time continuous glucose monitor now or in six
months.
Home procedures: If you are in the group using the real-time continuous glucose monitor during the first six months, you should use the real-time continuous glucose monitor daily. If
you are in the group that is not given the real-time continuous glucose monitor at the beginning
of the study, you should not use the real-time continuous glucose monitor during the first six
months. You will be asked to use a real-time continuous glucose monitor that will be blinded so that the subject will not be able to review the real time data. This will occur the week following the 13 and 26 week visit. We will give you a real-time continuous glucose monitor to use after the first six months.
For the first six months subjects
in both groups will be expected to do the following:
1. Check blood sugar with the
home glucose meter that the study will provide
2. Download the devices for the
study. Control group will also:
3. Use a real-time continuous glucose monitor that will be blinded so that the subject will not be able to view the real time data. This will occur the week following the
13 and 26 week visit.
After six months, if you used the real-time continuous glucose monitor in the first six
months, you will continue using it for the next six months. If you
did not use the real-time continuous glucose monitor, you will be given a real-time continuous glucose monitor and new instructions
for making diabetes management decisions based on the real-time continuous glucose monitor and
home glucose meter results.
Study visits and phone calls:
First six months: You will have a visit at 1,4,8,13, 19, and
26 weeks after your Baseline Visit. At these visits the following will occur:
- Devices for the study will be downloaded and the data reviewed with you.
If you use an insulin pump that can be downloaded, this will be done.
- Blood will be drawn to measure your HbA1C.
- You will complete questionnaires.
Phone calls will occur 2, 6, 10, 16, and 22 weeks after your Baseline Visit.
- If the subject is able to download their study devices at home that data will be reviewed.
- Questions regarding the subjects diabetes management will be asked.
Second six months:
During the second six months of the study if you were in the group without the real time-continuous glucose monitor in the first part of the study you will be seen 1, 2, 4, 13, and 26 weeks after the 26 week visit of the first six months of the study. If you were in the group that used the real-time-continuous glucose monitor in the first six months of the study, you will be seen 13 and 26 weeks after the 26 week visit of the first six months of the study.
-
Devices for the study will be downloaded and the data reviewed with you. If you use an insulin pump that can be downloaded, this will also be done.
-
Blood will be drawn to measure your HbA1c.
-
You will complete questionnaires.
Phone calls will only occur for the subjects that were without the real time-continuous glucose monitor in the first part of the study at 3 days, and 2 weeks after their week 1 visit of the second six months. The group that used the real time-continuous glucose monitor will not have any scheduled phone contacts in the second six months of the study.
-
If the subject is able to download their study devices at home that data will be reviewed.
-
Questions regarding the subjects diabetes management will be asked.
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Contact |
Contact: If you are interested in having either you or your child participate in this study, please review the consent form. Once you have reviewed these forms, please contact us to discuss your eligibility and any questions you may have.
Jen
Block, RN, CDE Phone: (650) 736-8142 Email: jblock@stanford.edu
Kari Santibanes-Benassi, FNP Phone: (650) 736-7948 Email: karis@stanford.edu
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