- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01390610
Continuous Glucose Monitoring Self-Monitored Blood Glucose Type 2 Therapy Matrix Definition (REACT4)
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)
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Derive optimum Self Monitored Blood Glucose (SMBG) testing patterns from CGM data. CGM data will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
Time Frame: 2 weeks of CGM data
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2 weeks of CGM data
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roger S Mazze, PhD, International Diabetes Center at Park Nicollet
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04111-11-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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