Type 1 Diabetes Clinical Trial
Official title:
A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0%
in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring
(CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A
parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will
follow an identical protocol to that of the first cohort with HbA1c >=7.0%.
The >=7.0% trial was specifically designed and statistically powered to compare separately
the impact of continuous versus standard intensive glucose monitoring in the three age
groups. Both trials used standardized treatment algorithms and equivalent frequent contacts
with subjects in both the CGM and control group.
After completion of the 26-week trial, the CGM group continues to use CGM for another 26
weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with
longer-term use and less intensive contact and the control group initiates CGM use with less
intensive contact after the first month than was provided at initiation of CGM use in the
CGM group in the randomized trial.
1. On the day of enrollment, a glycated hemoglobin (HbA1c) level will be obtained,
psychosocial questionnaires will be completed, and instructions will be given for use
of the real time continuous glucose monitoring device (RT-CGM). The study personnel
will supervise the subject or parent inserting the RT-CGM sensor in the clinic and will
instruct the subject or parent to insert a second sensor at home as needed. To obtain a
baseline assessment of glycemic control and variability, the RT-CGM used during the
first week will be blinded so subjects will not be able to view the data from the
sensor. The subject will be instructed to complete at least four glucose measurements a
day using the study home glucose meter (HGM) and as needed to calibrate the RT-CGM.
2. The subject will return for a second visit about 10 days after the enrollment visit.
- Subjects who have been compliant with use of the RT-CGM and HGM will be randomized
to one of two treatment groups: RT-CGM Group or Control Group.
- Compliance will be defined as use of the RT-CGM for at least 6 out of the 7
days prior to the second visit, at least 96 hours of RT-CGM glucose values
obtained with at least 24 hours between the hours of 10 p.m. and 6 a.m., and
use of the HGM for testing at least 3 times each day prior to the second
visit.
- Subjects who are not compliant will be given another opportunity to complete
the baseline requirements at the discretion of the investigator.
- For the RT-CGM Group, the RT-CGM, HGM, and pump data (if subject uses an insulin
pump) will be reviewed and changes will be made to diabetes management as needed.
Subjects/parents will be taught to use the protocol-developed instructions for
changes to diabetes management to be used in real time based on RT-CGM and HGM
data. Instructions for downloading the RT-CGM and HGM will be provided to subjects
with a home computer.
- For the Control Group, a HGM and test strips will be provided. The HGM and pump
data (if subject uses an insulin pump) will be reviewed and changes made in
diabetes management as needed. The blinded RT-CGM data will be downloaded but will
not be reviewed by study personnel until the end of the first 6 months of the
study. Subjects and parents will be taught to use the protocol-developed
instructions for how to make changes to diabetes management based on HGM data.
3. Both groups will have follow-up visits at 1, 4, 8, 13, 19, and 26 weeks (+/- 1 week)
plus one phone contact between each visit (including one phone contact between the
second visit and the one week visit) to review their diabetes management.
- Both groups will download device data on a weekly basis (if the subject has a
computer). Subjects with email access will be instructed to email the downloaded
data to the clinical center prior to each phone contact.
- For both groups, at each visit, the HGM and pump (if subject uses an insulin pump)
will be downloaded and for the RT-CGM Group, the RT-CGM will be downloaded.
4. In the 13th and 26th weeks, the Control Group will use a blinded RT-CGM for one week.
The RT-CGM Group will continue to use the unblinded RT-CGM. The Control Group will
return the blinded RT-CGM to the clinic after a week. The data will be reviewed by
personnel who are not involved in the care of the subject to determine if additional
blinded sensor data are needed. The blinded data will not be reviewed by study
personnel for management decisions until the end of the first 6 months of the study.
5. Following the 26-week visit:
- Subjects in the RT-CGM Group will continue to use the RT-CGM.
- Subjects in the Control Group will be provided with a RT-CGM and sensors after the
week of blinded use and will have visits after 1 week and 4 weeks, with a phone
contact during the first and third weeks.
- Both groups will have visits after 13 weeks and 26 weeks (study time 9 and 12
months).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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