Continuous Glucose Monitoring Self-Monitored Blood Glucose Type 2 Therapy Matrix Definition
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | January 2013 |
Observational Evaluation Using Continuous Glucose Monitoring to Determine Timing and Frequency of Self-Monitored Blood Glucose by Therapy Type in Patients With Type 2 Diabetes (REACT-4 Matrix Definition Study)
The purpose of this study is to use data from the Continuous Glucose Monitoring (CGM) device
and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test
blood glucose levels using SMBG.
and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test
blood glucose levels using SMBG.
The investigators propose to employ CGM technology in subjects using insulin sensitizers,
incretin mimetics and potentiators, insulin secretagogues and insulin to identify the
minimum episodic data set that closely mimics CGM data. Specifically, the investigators
propose to employ blinded CGM for 2 weeks to capture the diurnal glucose patterns of
individuals on different therapeutic regimens. The investigators propose to examine these
data to determine whether a specific pattern of SMBG testing derived from these data would
provide the same information (e.g., detection of hypoglycemia, measures of glycemic
exposure, variability and stability) not possible by relying solely on current SMBG testing
schedules.
In preparation for this study the investigators developed a matrix using data collected from
previous studies. The matrix summarizes the amount of CGM data the investigators currently
possess and indicates where the investigators lack sufficient data to produce SMBG testing
schedules based on CGM data. It was determined that 6 cases were needed for each therapy
group. An underlying question is whether after the investigators fill this matrix the
investigators can discover a common testing pattern for SMBG that would provide sufficient
information to uncover the myriad perturbations in glucose patterns that characterize type 2
diabetes. To assure that the investigators are collecting adequate monitoring data, the
investigators propose to use Ambulatory Glucose Profile (AGP) analysis of blinded CGM data.
This novel approach will enable us to answer the question as to the optimum time and number
of SMBG tests sufficient to guide clinical decisions.
incretin mimetics and potentiators, insulin secretagogues and insulin to identify the
minimum episodic data set that closely mimics CGM data. Specifically, the investigators
propose to employ blinded CGM for 2 weeks to capture the diurnal glucose patterns of
individuals on different therapeutic regimens. The investigators propose to examine these
data to determine whether a specific pattern of SMBG testing derived from these data would
provide the same information (e.g., detection of hypoglycemia, measures of glycemic
exposure, variability and stability) not possible by relying solely on current SMBG testing
schedules.
In preparation for this study the investigators developed a matrix using data collected from
previous studies. The matrix summarizes the amount of CGM data the investigators currently
possess and indicates where the investigators lack sufficient data to produce SMBG testing
schedules based on CGM data. It was determined that 6 cases were needed for each therapy
group. An underlying question is whether after the investigators fill this matrix the
investigators can discover a common testing pattern for SMBG that would provide sufficient
information to uncover the myriad perturbations in glucose patterns that characterize type 2
diabetes. To assure that the investigators are collecting adequate monitoring data, the
investigators propose to use Ambulatory Glucose Profile (AGP) analysis of blinded CGM data.
This novel approach will enable us to answer the question as to the optimum time and number
of SMBG tests sufficient to guide clinical decisions.
Inclusion Criteria:
- Male or female
- Diagnosed with type 2 diabetes and treated with diabetes medication(s) as required by
the protocol (See Section 3.1)
- Age 18 and older
- Willing to give informed consent
- Motivated and capable of following the protocol and instructions provided by the
healthcare professional
- Available for the study on the scheduled visit days
- Have not participated in a prior research trial at IDC that utilized CGM
Exclusion Criteria:
- Under 18 years of age
- Skin abnormalities at the CGM insertion sites that would confound assessment of the
effect of the device on the skin
- Allergy to adhesives
- Taken prednisone or cortisone medications in the previous 30 days
- Currently pregnant or planning pregnancy during the study period
- Presence of any severe medical or psychological condition or chronic
conditions/infections that in the opinion of the Investigator would compromise the
subject's safety or successful participation in the study
- Unable to follow the study protocol
- Unable to speak, read and write in English
We found this trial at
1
site
Click here to add this to my saved trials
