Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes

NCT02033499 | Completed Results

• 1 other identifier: 13-2047
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

Keywords

Blood Glucose Self-Monitoring; Self-Monitoring, Blood Glucose; Diabetes Mellitus, Type 2; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Absolute Change in % Hemoglobin A1c From Baseline at 52 Weeks

  Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks

  Baseline to 52 weeks

• Mean Difference in Health-related Quality of Life Scores From 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.

  Baseline to 52 weeks

Secondary Outcomes (9)

• Change in Problem Areas in Diabetes Scores From Baseline to 52 Weeks

  Baseline to 52 weeks

• Change in Diabetes Symptom Checklist- Revised (DSC-R) Overall Score From Baseline to 52 Weeks

  Baseline to 52 weeks

• Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks

  Baseline to 52 weeks

• Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks

  Baseline to 52 weeks

• Change Diabetes Empowerment Scale - Short Form (DES-SF) From Baseline to 52 Weeks

  Baseline to 52 weeks

Study Arms (3)

No testing

NO INTERVENTION

No testing

standard messaging

OTHER

SMBG standard messaging

Behavioral: SMBG

enhanced messaging

OTHER

SMBG enhanced messaging

Behavioral: SMBG

Interventions

SMBG BEHAVIORAL

Blood glucose levels are tested once daily.

Also known as: Self-monitoring of blood glucose with a Telcare glucometer

enhanced messaging; standard messaging

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (10)

• Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.

  PMID: 18945920 BACKGROUND

• Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). U.K. Prospective Diabetes Study Group. Diabetes Care. 1999 Jul;22(7):1125-36. doi: 10.2337/diacare.22.7.1125.

  PMID: 10388978 BACKGROUND

• Vijan S. In the clinic. Type 2 diabetes. Ann Intern Med. 2010 Mar 2;152(5):ITC31-15; quiz ITC316. doi: 10.7326/0003-4819-152-5-201003020-01003.

  PMID: 20194231 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.

  PMID: 24357209 BACKGROUND

• Towfigh A, Romanova M, Weinreb JE, Munjas B, Suttorp MJ, Zhou A, Shekelle PG. Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis. Am J Manag Care. 2008 Jul;14(7):468-75.

  PMID: 18611098 BACKGROUND

• Allemann S, Houriet C, Diem P, Stettler C. Self-monitoring of blood glucose in non-insulin treated patients with type 2 diabetes: a systematic review and meta-analysis. Curr Med Res Opin. 2009 Dec;25(12):2903-13. doi: 10.1185/03007990903364665.

  PMID: 19827909 BACKGROUND

• Farmer AJ, Perera R, Ward A, Heneghan C, Oke J, Barnett AH, Davidson MB, Guerci B, Coates V, Schwedes U, O'Malley S. Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ. 2012 Feb 27;344:e486. doi: 10.1136/bmj.e486.

  PMID: 22371867 BACKGROUND

• Kowitt SD, Donahue KE, Fisher EB, Mitchell M, Young LA. How is neighborhood social disorganization associated with diabetes outcomes? A multilevel investigation of glycemic control and self-reported use of acute or emergency health care services. Clin Diabetes Endocrinol. 2018 Oct 19;4:19. doi: 10.1186/s40842-018-0069-0. eCollection 2018.

  PMID: 30377539 DERIVED

• Young LA, Buse JB, Weaver MA, Vu MB, Mitchell CM, Blakeney T, Grimm K, Rees J, Niblock F, Donahue KE; Monitor Trial Group. Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial. JAMA Intern Med. 2017 Jul 1;177(7):920-929. doi: 10.1001/jamainternmed.2017.1233.

  PMID: 28600913 DERIVED

• Young LA, Buse JB, Weaver MA, Vu MB, Reese A, Mitchell CM, Blakeney T, Grimm K, Rees J, Donahue KE. Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol. BMC Health Serv Res. 2017 May 25;17(1):369. doi: 10.1186/s12913-017-2202-7.

  PMID: 28545493 DERIVED

Related Links

• National diabetes information clearinghouse

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Dr. Katrina Donahue
• Organization: University of North Carolina at Chapel Hill

Katrina_Donahue@med.unc.edu

919-966-5090

Study Officials

• Katrina E Donahue, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Laura A Young, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators including the bio-statistician were blind to the study assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 14, 2017
• Results First Posted: December 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)