Continuous Glucose Monitoring Self-Monitored Blood Glucose Type 2 Therapy Matrix Definition (REACT4)

This study has been completed.
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01390610
First received: June 29, 2011
Last updated: May 13, 2013
Last verified: April 2013
  Purpose

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.


Condition
Diabetes Mellitus, Type 2
Diabetic Blood Glucose Monitoring

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Twenty seven persons with type 2 diabetes age 18 and older.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390610

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Abbott Diabetes Care
Investigators
Principal Investigator: Roger S Mazze, PhD International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01390610     History of Changes
Other Study ID Numbers: 04111-11-C
Study First Received: June 29, 2011
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Continuous Glucose Monitoring
Self Monitored Blood Glucose
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014