Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
Katrina Donahue, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02033499
First received: January 7, 2014
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)
Behavioral: SMBG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Glucose Monitoring on Patient and Provider Outcomes in Non-insulin Treated Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Glycemic Control at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
    Change in Hemoglobin A1c from baseline at 52 weeks

  • Change from baseline Quality of Life scores at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change in SF-36 scores from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life.


Secondary Outcome Measures:
  • Change from baseline Problem Areas in Diabetes scores at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    The change from baseline Problem Areas in Diabetes (PAID) scores will be assessed at 52 weeks. The PAID is a widely used tool to assess psychological and social stress associated with diabetes.

  • Change from baseline Diabetes Symptom Checklist score at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change in diabetes-related symptom frequency and perceived severity from baseline at 52 weeks using the Diabetes Symptom Checklist will be evaluated.

  • Change from baseline Summary of Diabetes Self Care Activities (SDCA) at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change in the SDCA, a multidimensional measure of diabetes self-management activities, from baseline at 52 weeks will be assessed.

  • Change from baseline Diabetes Treatment Satisfaction Questionnaire score at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline patient satisfaction with treatment at 52 weeks will be calculated.

  • Change from baseline Diabetes-Specific Self-Efficacy at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Changes in diabetes-specific self-efficacy using the Diabetes Empowerment Scale Short Form from baseline at 52 weeks will be evaluated.

  • Change from baseline Patient-Provider Communication at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from patient perception of communication with their provider will be measured at 52 weeks using the Communication Assessment Tool.

  • Hypoglycemia Frequency [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
    Downloaded SMBG values will be graded for hypoglycemia for the 52 week intervention period. Frequencies of episodes graded as a 3, 4, or 5 will be calculated for the 52 week study period.

  • Change from baseline Health Care Utilization at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Inpatient, outpatient, urgent care, and emergency department visits will be recorded at baseline and 52 weeks and change scores will be evaluated at 52 weeks.

  • Change in Treatment Regimen [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Changes in diabetes medications will be evaluated from baseline at 52 weeks.


Other Outcome Measures:
  • Qualitative Assessment of Patient Outcomes [ Time Frame: once after 80% of patients have been recruited ] [ Designated as safety issue: No ]
    A patient focus group will be conducted in each practice to assess patient experience using the glucometer and messaging system.

  • Qualitative Assessment of Health Care Provider Outcomes [ Time Frame: once 80% of patients have been recruited ] [ Designated as safety issue: No ]
    A focus group that includes representatives from each of the participating practices will be convened toward the end of the study to assess the benefits/problems with the treatment recommendations and other aspects of the study.


Estimated Enrollment: 450
Study Start Date: January 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No testing
No testing
standard messaging
SMBG standard messaging
Behavioral: SMBG
Blood glucose levels are tested once daily.
Other Name: Self-monitoring of blood glucose with a Telcare glucometer
enhanced messaging
SMBG enhanced messaging
Behavioral: SMBG
Blood glucose levels are tested once daily.
Other Name: Self-monitoring of blood glucose with a Telcare glucometer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of type 2 diabetes
  • Age > 30
  • An established patient at the participating UNCPN practice who identifies a UNCPN health care provider within that practice as their primary provider of diabetes care.
  • A1c >6.5% but <9.5% within the 6 months preceding the screening call/visit, as obtained from the patient's medical record.
  • Willing to comply with the results of random assignment into a study group.

Exclusion Criteria:

  • Currently sees or plans to see an endocrinologist or other diabetes specialist in the next year.
  • Use of insulin
  • Is or plans to become pregnant in the next 12 months.
  • Plans to relocate in the next 12 months.
  • Has other conditions (e.g. renal or cardiovascular disease, poor visual acuity), other factors (e.g. frailty,) or comorbidities (e.g. cancer) that might put the patient at risk when following study protocols.
  • No history of significant issues with known or suspected hypoglycemia or any history of "severe" hypoglycemia (requiring assistance from a third party).
  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: NCT02033499

Contacts
Contact: C. Madeline Mitchell, MURP 919-966-6074 Madeline_Mitchell@unc.edu

Locations
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: C Madeline Mitchell, MURP    919-966-6074    Madeline_Mitchell@unc.edu   
Contact: Katrina Donahue, MD MPH    919-966-6614    Katrina_Donahue@med.unc.edu   
Principal Investigator: Katrina E Donahue, MD MPH         
Principal Investigator: Laura A Young, MD PhD         
Sub-Investigator: John B Buse, MD PhD         
Sub-Investigator: Mark A Weaver, PhD         
Sub-Investigator: Maihan Vu, DrPH         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Katrina E Donahue, MD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Laura A Young, MD, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: Katrina Donahue, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02033499     History of Changes
Other Study ID Numbers: 13-2047
Study First Received: January 7, 2014
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Blood Glucose Self-Monitoring
Self-Monitoring, Blood Glucose
Diabetes Mellitus, Type 2
Quality of Life

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

ClinicalTrials.gov processed this record on September 18, 2014