ClinicalTrials.gov
ClinicalTrials.gov Menu

Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02033499
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Katrina Donahue, MD, MPH, University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder) Behavioral: SMBG Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The investigators including the bio-statistician were blind to the study assignment.
Primary Purpose: Treatment
Official Title: Effect of Glucose Monitoring on Patient and Provider Outcomes in Non-insulin Treated Diabetes
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Absolute Change in % Hemoglobin A1c From Baseline at 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks

  2. Mean Difference in Health-related Quality of Life Scores From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. Each subscale score ranges from 0 - 100, with 100 being the best quality of life score.


Secondary Outcome Measures :
  1. Change in Problem Areas in Diabetes Scores From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    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. The PAID scores range from 0 to 100, with 100 indicating the most distress.

  2. Change in Diabetes Symptom Checklist- Revised (DSC-R) Overall Score From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Change in diabetes-related symptom frequency and perceived severity from baseline at 52 weeks using the Diabetes Symptom Checklist-Revised. Overall score ranges from 0 to 170, with 170 indicating the worse symptom severity.

  3. Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Change in the SDCA subscales (general diet, specific diet, exercise, blood sugar testing, and foot care), a multidimensional measure of diabetes self-management activities, from baseline at 52 weeks will be assessed. For each subscale, the score is the mean number of days specified subscale activities occurred. Each subscale ranges from 0 to 7, with 7 the best score possible.

  4. Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Change from baseline patient satisfaction with treatment at 52 weeks using the Diabetes Treatment Satisfaction Questionnaire subscales, overall satisfaction and satisfaction with blood glucose control. For overall satisfaction, the range is 0-36, with 36 (high score) being the most satisfied. For satisfaction with blood glucose control, the subscale range is 0 to 12, with 0 (low score) indicating the most satisfaction.

  5. Change Diabetes Empowerment Scale - Short Form (DES-SF) From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Changes in diabetes-specific self-efficacy using the Diabetes Empowerment Scale - Short Form from baseline at 52 weeks. The scale ranges from 1 to 5, with 5 indicating most empowered.

  6. Change in Patient-Provider Communication From Baseline to 52 Weeks [ Time Frame: Baseline to 52 weeks ]
    Change from baseline patient perception of communication with their provider at 52 weeks using the Communication Assessment Tool (CAT). Scale scores range from 1 to 5, with 5 being the best communication.

  7. Hypoglycemia Frequency [ Time Frame: Baseline to 52 weeks ]
    Number of participants with hypoglycemia events for the 52 week intervention period.

  8. Baseline Health Care Utilization and at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
    Primary care visits, hospitalization, urgent care, and emergency room and emergency medical service (EMS) visits recorded at baseline and 52 weeks.

  9. Number of Participants on Specified Diabetes Medications at Baseline and Follow-up [ Time Frame: Baseline and 52 weeks ]
    Number of participants taking each of the following medications at baseline and follow-up: metformin, sulfonylurea, glinides, Glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), and dipeptidyl peptidase IV (DPP-IV).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of type 2 diabetes
  • Age > 30
  • An established patient at the participating UNC Physicians Network (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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033499


Locations
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Patient-Centered Outcomes 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

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrina Donahue, MD, MPH, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02033499     History of Changes
Other Study ID Numbers: 13-2047
First Posted: January 10, 2014    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified public use data files and documentation will allow researchers to have access to the final research data collected for this study. Care will be taken to remove indirect identifiers or other information that could result in the inadvertent disclosure of participants' identities due to the occurrence of unusual data elements. The public use database will be stored at the University of North Carolina's Sheps Center for Health Services Research. Researchers who would like access to the public-use data files for this study must enter into a data use agreement to ensure that the information will be used solely for statistical analysis or research reporting purposes. The project co-investigators in conjunction with the project manager will review requests for data and authorize provision of instructions and passwords needed to download the dataset. The public use data will be available after submission of the publication reporting the main trial findings.

Keywords provided by Katrina Donahue, MD, MPH, 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