Examining The Role of CGM in T2DM

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medtronic
Atlanta Diabetes Associates
UNC Coordinating Center
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01614262
First received: June 5, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.


Condition Intervention
Type 2 Diabetes, Non-Insulin Treated
Other: Continuous Glucose Monitoring with treatment algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Examining the Role of Continuous Glucose Monitoring (CGM) in Non-Insulin Treated Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring [ Time Frame: baseline and day 187 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in fasting plasma glucose between two groups [ Time Frame: baseline and day 187 ] [ Designated as safety issue: No ]
  • comparison of change of the area under the curve for CGM results for both treatment arms [ Time Frame: baseline and day 187 ] [ Designated as safety issue: No ]
  • quality of life data evaluation [ Time Frame: baseline and day 187 ] [ Designated as safety issue: No ]
    Provide preliminary data on the effect of CGM monitoring on subjects' quality of life.


Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Glucose Monitoring
The CGM arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data
Other: Continuous Glucose Monitoring with treatment algorithm
those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
Active Comparator: Self Monitoring Blood Glucose
Subjects in the SMBG group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care.
Other: Continuous Glucose Monitoring with treatment algorithm
those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.

Detailed Description:

The study will enroll and follow 90 participants for 187 days at two sites. Participants will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the SMBG based intervention (Group 2). Group 1 will receive care based upon the results of their CGM data while group 2 will receive care based upon traditional self-monitoring blood glucose (SMBG values). The clinical management algorithm will be utilized to guide the care of all subjects. All study participants will receive the iPro 2 devices (Medtronic Minimed, Northridge, CA 91325) to collect glucose measurements during five 1 week periods beginning on Day 0, Day 45, Day 90, Day 135 and Day 180. Laboratory measures of glucose control (HbA1c and FPG) and quality of life outcomes will be evaluated at Day 0, Day 90 and Day 187.

The iPro2 device is FDA approved for sale in the US and is a commercial product. The iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. The iPro 2 is intended to be worn for intermittent periods to uncover glycemic variability and patterns. The data obtained can then be used to maximum treatment strategies to improve patient outcomes. The advantage to the iPro 2 is that it is blinded and will not be influenced by the patient.

The Enlite sensor, is an investigational device, is a 6 day sensor. The subjects in this study will wear the Enlite sensor for a 6 day monitoring period. The Enlite sensor is CE-marked and available for sale in over 50 countries and is currently seeking FDA approval.

CareLink iPro Clinical Therapy Management Software is part of the iPro2 CGM system. The Carelink iPro Clinical Software is intended to support clinical trials. This internet based software allows data to be viewed and easily evaluated by physicians. A PC links to Carelink iPro Clinical via the Internet and allows the user to upload data from Medtronic Diabetes iPro2 devices. Because the algorithm proposed in this protocol has been programed into the Software, this is an investigational product.

Adult individuals 18-70 years of age, diagnosed with T2DM who are currently being treated in the Principal Investigators or referring physicians practice with a HbA1c between 7.5-9.0%.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A subject is eligible for the study if all of the following criteria are met:

    1. Provide written informed consent prior to enrollment
    2. Is male or female between 18-70 years old
    3. Has been treated by the Principal Investigator or referring physician in the same practice.
    4. Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
    5. Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
    6. Currently performs self-monitoring blood glucose checks at least 3 times per week.
    7. Ability to adhere to protocol requirements.

Exclusion Criteria:

  • 1. Has Type 1 Diabetes or Gestational Diabetes

    2.Is pregnant or planning to become pregnant during the course of the study.

    3.Current use of any insulin or history of insulin use in the last 6 months.

    4.An acute coronary or cerebrovascular event in the previous 3 months.

    5.Any planned surgery during the course of the study.

    6.Current continuous renal replacement therapy.

    7.BMI ≥ 45 kg/m^2

    8.Current oral or injectable steroid use.

    9.Any previous history Continuous Glucose Monitoring use by any device or manufacturer.

    10.Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

  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: NCT01614262

Locations
United States, Georgia
Atlanta Diabetes Assoicates
Atlanta, Georgia, United States, 30309
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Medtronic
Atlanta Diabetes Associates
UNC Coordinating Center
Investigators
Principal Investigator: John B Buse, MD, PhD University of North Carolina
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01614262     History of Changes
Other Study ID Numbers: 12-0899
Study First Received: June 5, 2012
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014