Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes
Condition: DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin,
      decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a
      resource intensive activity without firmly established patient benefits. While SMBG holds
      great promise for sparking favorable behavior change, the potential for no benefit or even
      patient harm must be acknowledged. Possible negative effects on patient quality of life must
      be more closely examined along with the speculative benefits of SMBG in non-insulin treated
      T2DM. Among studies examining this issue a general consensus is evolving; while SMBG may or
      may not be useful, its value can only be fully appreciated when the SMBG results are provided
      to patients in a useful manner. The overarching goal of this proposal is to assess the impact
      of three different SMBG testing approaches on patient-centered outcomes in patients with
      non-insulin treated T2DM within the real-world, clinic setting. In this pragmatic trial, 450
      patients will be randomized to one of the following three SMBG testing regimens: 1) no SMBG
      testing, 2) once daily SMBG testing with standard patient feedback consisting of glucose
      values being immediately reported to the patient through the glucose meter, and 3) once daily
      SMBG testing with enhanced patient feedback consisting of glucose values being immediately
      reported to the patient plus automated, tailored feedback messaging. The first two arms
      represent common SMBG testing approaches. The third arm is an enhanced, patient-centered
      approach to SMBG testing. SMBG values will be evaluated at routine clinic visits over 52
      weeks.
    

Detailed description: 
      Within the context of a controlled and randomized but pragmatic trial, we seek to answer the
      following question: does SMBG testing make sense for Non-insulin treated (NIT) diabetes
      mellitus (DM) patients in terms of either A1c values or Health-related Quality of Life (QOL).
      We will also examine whether or not patients with different baseline characteristics might
      see different outcomes from three SMBG testing approaches. To achieve our goal of testing
      SMBG options in community-based primary care practices, the study has been designed to
      minimize as much as possible any interruptions in or alterations to standard daily patient
      care. We will recruit 450 patients from five primary care practices. Patients will be
      followed for one year. During routine clinic visits, their health care providers will be
      guided to modify therapies based on American Diabetes Association (ADA) guidelines, which
      focus on A1c values and SMBG values if available.

      Study Arms Two of the three study arms were chosen to reflect existing, widely used options
      for patients with NIT DM. Arm 3, described below, of this trial is particularly novel in that
      it tests the potential benefit of new technology now available to these patients; namely,
      wireless transmission of blood glucose test results accompanied by instantaneous tailored
      feedback. While this option may hold great promise for patients and their providers, data
      supporting this are lacking. The results of this study will inform consumers and providers
      about whether this new technology can support efforts to alter behaviors in a way that
      results in improved A1c values or better quality of life. Particularly appealing is that this
      approach employs technology that supports more efficient use of SMBG values by both patients
      and their providers. In terms of their pragmatic 'fit', all three groups fit easily into
      current practice at the participating practices. For example, they do not require extra
      clinic visits (other than possibly the initial recruitment assessment), and while staff will
      need to download glucose reports for patients in Arms 2 and 3, this will be a very simple,
      streamlined procedure. In terms of risks to patients, none of the three groups puts patients
      at any additional risk, because all three are versions of 'standard practice' for this
      patient population and doctors are free to alter therapies and testing schedules as they
      normally would.

        -  Arm 1: No SMBG Testing This group represents an approach to SMBG that is supported by
           research and followed by many primary care providers. Patients randomized to this group
           will not be provided a meter, but will receive standardized education detailing the
           signs and symptoms of hyper- and hypoglycemia and information regarding lifestyle
           approaches for the maintenance of normoglycemia. If they have previously been obtaining
           SMBG values, they will be asked to discontinue. Healthcare providers and staff will be
           alerted that these patients are in the no testing arm and will be encouraged to maintain
           treatment fidelity except where patient safety is a concern. Study coordinators will
           provide patients with both written and oral educational information supporting the
           approach of no SMBG testing, with a view toward reconciling any messages they may have
           received in the past or will receive in the future regarding SMBG. This education will
           recur every 3-6 months at routine clinic visits (the recommended follow-up frequency for
           persons with T2DM) by their health care providers. A1c will be obtained during these
           visits as per usual care and providers will adjust medication and lifestyle
           recommendations as they see fit. Providers will be given an algorithm based on current
           ADA recommendations relating to A1c results to use as a guide for treatment
           modification.

        -  Arm 2: Once Daily Testing with Standard Feedback This group represents an approach taken
           by a large proportion of NIT DM patients in the US. At the assessment visit, patients
           will be given the study glucose meter and testing supplies, along with instruction for
           their use. They will be asked to test once daily and at different times of the day on a
           rotating basis, in order to obtain a representative distribution of blood glucose values
           over time. The meter will have wireless capability such that it will transmit both the
           SMBG result and the time of testing to a secure server. Subjects will also note the
           circumstances of their test times on the glucose meter (e.g., fasting, 2 hours post
           meal, etc.) and this information will also be sent to the server. As with Arm 1, Arm 2
           patients will receive training in hyper- and hypoglycemia and approaches for maintaining
           normoglycemia. They will also receive training and written material instructing them in
           how to interpret their SMBG readings and actions they might take in response to those
           values. SMBG results will be reviewed at all clinic visits (3-6 month intervals) by the
           primary care provider using a print out of glucose meter values downloaded and analyzed
           wirelessly. During the early phase of the project, a streamlined system will be
           developed to allow participating clinic staff to download the SMBG values with minimal
           effort and create the accompanying SMBG report for the patient's provider. This
           customized report, detailing blood glucose averages, ranges and standard deviations,
           will be generated for all group 2 participants and given to their provider prior to each
           routine clinic visit. The report will identify problematic glucose values (hypo- and
           hyperglycemia) and suggested approaches for addressing these problems. Providers will
           review the results with the participant and make appropriate treatment recommendations
           based upon blood glucose trends. The recommendations in the report will be driven by an
           algorithm for treatment modification based upon ADA guidelines which will include
           suggestions for both lifestyle and pharmacotherapy adjustments. At the end of each
           clinic visit, patients will be instructed by their primary care provider to continue
           once daily testing. Using shared decision-making and standardized testing
           recommendations, the health care provider and the patient will jointly determine the
           testing approach (e.g., timing of once daily testing) the patient will employ over the
           next monitoring period.

        -  Arm 3: Once Daily Testing with Enhanced Feedback This Arm represents an enhanced,
           patient-centered approach. Participants randomized to Arm 3 will, like the Arm 2
           participants, be instructed to test once daily and at different times of the day, and
           their glucose values will be transmitted wirelessly to a server. However, for Arm 3
           participants, the blood glucose values will be analyzed automatically each time a value
           is transmitted. Based upon the value, instantaneous personalized feedback will be
           provided via wireless messaging to the patients' glucose meters. These messages will not
           include suggestions for pharmacological therapy modification but will be motivational in
           nature, including suggestions to enhance efforts at lifestyle management and adherence
           to pharmacologic therapy if prescribed. At weekly intervals, an analysis of the SMBG
           values from the previous week will be sent to the glucose meter highlighting trends and
           identifying specific problematic times. Subjects will also receive messages reminding
           them of upcoming clinic visits (beginning 1 week prior to their scheduled visit). As
           with Arm 2, SMBG results and customized reports will be downloaded and reviewed at all
           clinic visits by the primary care provider. In addition, a summary of the messages sent
           wirelessly to the patient since the most recent visit will be included. Like the glucose
           values report, this message report will be given to all providers at the beginning of
           the clinic visit and providers will be asked to also review these results with the
           patient. Providers will make appropriate treatment recommendations based upon blood
           glucose trends and messages. Report recommendations will be driven by an algorithm for
           treatment modification based upon ADA treatment guidelines and include suggestions for
           lifestyle and pharmacotherapy adjustments. At the end of the clinic visit, patients will
           be instructed by their primary care provider to continue testing their blood glucose
           once daily and collaboratively determine the testing approach (e.g., timing of once
           daily testing) the patient will employ over the next monitoring period.

      Potential Alterations to the Testing Recommendations: Providers will be strongly encouraged
      to maintain SMBG testing fidelity based upon the treatment arm to which a patient is
      randomized; however, if a provider believes that testing should occur more frequently due to
      concern for serious unrecognized hypo- or hyperglycemia or for any other reason, testing
      recommendations may be modified. This approach provides for patient safety and preserves the
      pragmatic nature of the trial. Glucose testing strips will be provided to participants on a
      quarterly basis. If a provider deems that SMBG testing should occur more frequently than what
      is recommended to the patient based on the study arm to which he or she has been randomized,
      the health care provider must write the prescription for the additional test strips and the
      strips must be paid for out-of-pocket or through insurance. Following an intention to treat
      model, patients who opt not to follow the testing regimen to which they were randomly
      assigned will be encouraged to remain in the study. Any deviations from the assigned SMBG
      testing protocol will be readily known via the glucose meter reports.

      Mixed methods approach. A mixed methods approach in which both qualitative and quantitative
      data are collected provides advantages when exploring complex research questions such as the
      ones posed in this proposal. The quantitative data will allow us to assess changes in
      objective measures, while the qualitative data will provide a deeper understanding of
      patients' and providers' experiences with the various components of SMBG testing arms (e.g.,
      the meters, SMBG results, personalized messaging, downloadable reports, treatment algorithms,
      etc.) It is also the case that, while some patients are interested in seeing hard facts and
      figures, others prefer testimonials from patients like themselves. The mixed methods approach
      enables us to provide both types of information, increasing the effectiveness and uptake of
      our dissemination efforts.

      Recruitment and randomization procedures. Patient Recruitment: All potentially eligible
      patients expressing interest in the study will complete an initial screening phone call. The
      call will take about 15 minutes, during which a member of the study team will describe the
      study, answer questions, and conduct a short set of simple screening to determine
      eligibility. Eligible patients who remain interested in participation will complete an
      assessment visit with a research coordinator. To decrease patient burden and further engage
      participating practices, assessment visits will occur at the patient's primary care office.
      Assessments will be separate from their appointment with their primary care provider, and may
      or may not occur on the same day as a regularly scheduled clinic visit, though for patient
      convenience we will make every effort to coordinate the assessments with a regular clinic
      visits. During these assessments, the research coordinator will review the study details in
      greater depth, verify all inclusion and exclusion criteria, and obtain written informed
      consent.

      Patient Randomization: After providing informed consent, baseline A1c, and completing all
      baseline study questionnaires, participants will be randomized to one of the three arms using
      sequentially numbered, opaque, sealed envelopes. The research coordinator will review the
      treatment assignment with the patient, using a standardized script, provide the training and
      supplies necessary for participation in that study arm and answer any remaining questions.
    

Intervention name(s): SMBG
Intervention type(s): Behavioral
Intervention description(s): Blood glucose levels are tested once daily.
Other intervention name(s): Self-monitoring of blood glucose with a Telcare glucometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Blood Glucose Self-Monitoring; Self-Monitoring, Blood Glucose; Diabetes Mellitus, Type 2; Quality of Life