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BMC Health Services Research
Published in: BMC Health Services Research 1/2017

Open Access 01-12-2017 | Study protocol

Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol

Authors: Laura A. Young, John B. Buse, Mark A. Weaver, Maihan B. Vu, April Reese, C. Madeline Mitchell, Tamara Blakeney, Kimberlea Grimm, Jennifer Rees, Katrina E. Donahue

Published in: BMC Health Services Research | Issue 1/2017

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Abstract

Background

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) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting.

Methods/Design

Using stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control.

Discussion

This pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed.

Trial registration

ClinicalTrials.gov NCT02033499, January 9, 2014.
Literature
1.
Malanda UL, Bot SD, Nijpels G. Self-monitoring of blood glucose in noninsulin-using type 2 diabetic patients: it is time to face the evidence. Diabetes Care. 2013;36:176–8.CrossRefPubMed
2.
Standards of medical care in diabetes--2014. Diabetes Care. 2014;37 Suppl 1:S14-80.
3.
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;25:2903–13.CrossRefPubMed
4.
Clar C, Barnard K, Cummins E, Royle P, Waugh N, Aberdeen Health Technology Assessment G. Self-monitoring of blood glucose in type 2 diabetes: systematic review. Health Technol Assess (Winchester, England). 2010;14:1–140.
5.
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. Br Med J. 2012;344:e486–6.
6.
Malanda UL, Welschen LM, Riphagen II, Dekker JM, Nijpels G, Bot SD. Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database Syst Rev (Online). 2012;1:CD005060.
7.
Poolsup N, Suksomboon N, Rattanasookchit S. Meta-analysis of the benefits of self-monitoring of blood glucose on glycemic control in type 2 diabetes patients: an update. Diabetes Technol Ther. 2009;11:775–84.CrossRefPubMed
8.
Towfigh A, Ronnanova 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 Managed Care. 2008;14:468–73.CrossRef
9.
10.
Istepanian RS, Zitouni K, Harry D, Moutosammy N, Sungoor A, Tang B, Earle KA. Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes. J Telemed Telecare. 2009;15:125–8.CrossRefPubMed
11.
Bonomo K, De Salve A, Fiora E, Mularoni E, Massucco P, Poy P, Pomero A, Cavalot F, Anfossi G, Trovati M. Evaluation of a simple policy for pre- and post-prandial blood glucose self-monitoring in people with type 2 diabetes not on insulin. Diabetes Res Clin Pract. 2010;87:246–51.CrossRefPubMed
12.
Duran A, Martin P, Runkle I, Perez N, Abad R, Fernandez M, Del Valle L, Sanz MF, Calle-Pascual AL. Benefits of self-monitoring blood glucose in the management of new-onset Type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups. J Diabetes. 2010;2:203–11.CrossRefPubMed
13.
Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011;34:262–7.CrossRefPubMedPubMedCentral
14.
Franciosi M, Lucisano G, Pellegrini F, Cantarello A, Consoli A, Cucco L, Ghidelli R, Sartore G, Sciangula L, Nicolucci A, Group RS. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Diabetic Med. 2011;28:789–96.CrossRefPubMed
15.
Klonoff DC, Blonde L, Cembrowski G, Chacra AR, Charpentier G, Colagiuri S, Dailey G, Gabbay RA, Heinemann L, Kerr D, et al. Consensus report: the current role of self-monitoring of blood glucose in non-insulin-treated type 2 diabetes. J Diabetes Sci Technol. 2011;5:1529–48.CrossRefPubMedPubMedCentral
16.
Ware JE, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User manual for the SF-36v2 health survey. Lincoln: QualityMetric Inc; 2007.
17.
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;22:1125-1136.
18.
Anderson RT, Narayan KM, Feeney P, Goff Jr D, Ali MK, Simmons DL, Sperl-Hillen JA, Bigger T, Cuddihy R, O’Conner PJ, et al. Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial. Diabetes Care. 2011;34:807–12.CrossRefPubMedPubMedCentral
19.
Edelman D, Olsen MK, Dudley TK, Harris AC, Oddone EZ. Impact of diabetes screening on quality of life. Diabetes Care. 2002;25:1022–6.CrossRefPubMed
20.
Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed
21.
Snoek FJ, Pouwer F, Welch GW, Polonsky WH. Diabetes-related emotional distress in Dutch and U.S. diabetic patients: cross-cultural validity of the problem areas in diabetes scale. Diabetes Care. 2000;23:1305–9.CrossRefPubMed
22.
Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabetic Med. 2003;20:69–72.CrossRefPubMed
23.
Welch GW, Jacobson AM, Polonsky WH. The problem areas in diabetes scale. An evaluation of its clinical utility. Diabetes Care. 1997;20:760–6.CrossRefPubMed
24.
Herschbach P, Duran G, Waadt S, Zettler A, Amm C, Marten-Mittag B. Psychometric properties of the Questionnaire on Stress in Patients with Diabetes--Revised (QSD-R). Health Psychol. 1997;16:171–4.CrossRefPubMed
25.
Sacco WP, Bykowski CA, Mayhew LL. Pain and functional impairment as mediators of the link between medical symptoms and depression in type 2 diabetes. Int J Behav Med. 2013;20(1):22–29.
26.
Van der Does FE, De Neeling JN, Snoek FJ, Kostense PJ, Grootenhuis PA, Bouter LM, Heine RJ. Symptoms and well-being in relation to glycemic control in type II diabetes. Diabetes Care. 1996;19:204–10.CrossRefPubMed
27.
Parchman ML, Flannagan D, Ferrer RL, Matamoras M. Communication competence, self-care behaviors and glucose control in patients with type 2 diabetes. Patient Educ Couns. 2009;77:55–9.CrossRefPubMed
28.
Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011;28:715–23.CrossRefPubMedPubMedCentral
29.
Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The diabetes empowerment scale-short form (DES-SF). Diabetes Care. 2003;26:1641–2.CrossRefPubMed
30.
Dunnett CW, Tamhane AC. Step-up multiple testing of parameters with unequally correlated estimates. Biometrics. 1995;51:217–27.CrossRefPubMed
31.
O’Kane MJ, Bunting B, Copeland M, Coates VE. ESMON study group Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial. BMJ. 2008;336:1174–1177.
32.
Farmer AJ, Wade AN, French DP, Simon J, Yudkin P, Gray A, et al. Blood glucose self-monitoring in type 2 diabetes: A randomised controlled trial. Health Technol Assess. 2009;13(15):1–50.
33.
Benhalima K, Mathieu C. The role of blood glucose monitoring in non-insulin treated type 2 diabetes: What is the evidence? Prim Care Diabetes. 2012;6(3):179–85.
34.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach: Position statement of the american diabetes association (ADA) and the european association for the study of diabetes (EASD). Diabetes Care. 2012;35(6):1364–79.
Metadata
Title
Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol
Authors
Laura A. Young
John B. Buse
Mark A. Weaver
Maihan B. Vu
April Reese
C. Madeline Mitchell
Tamara Blakeney
Kimberlea Grimm
Jennifer Rees
Katrina E. Donahue
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2017
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-017-2202-7

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