Intervention Review

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin

  1. Uriëll L Malanda1,*,
  2. Laura MC Welschen1,
  3. Ingrid I Riphagen2,
  4. Jacqueline M Dekker3,
  5. Giel Nijpels1,
  6. Sandra DM Bot1,4

Editorial Group: Cochrane Metabolic and Endocrine Disorders Group

Published Online: 18 JAN 2012

Assessed as up-to-date: 7 JUL 2011

DOI: 10.1002/14651858.CD005060.pub3

Database Title

Additional Information

How to Cite

Malanda UL, Welschen LMC, Riphagen II, Dekker JM, Nijpels G, Bot SDM. Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD005060. DOI: 10.1002/14651858.CD005060.pub3.

Author Information

  1. 1

    VU University Medical Center, Department of General Practice, EMGO Institute for Health and Care Research, Amsterdam, Netherlands

  2. 2

    Norwegian University of Science and Technology, Unit for Applied Clinical Research, Faculty of Medicine, Trondheim, Norway

  3. 3

    VU University Medical Center, Departments of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, Amsterdam, Netherlands

  4. 4

    EMGO Institute for Health and Care Research, VU University Medical Center, Departments of Epidemiology and Biostatistics, Amsterdam, Netherlands

*Uriëll L Malanda, Department of General Practice, EMGO Institute for Health and Care Research, VU University Medical Center, PO Box 7057, Amsterdam, 1007 MB, Netherlands. u.malanda@gmail.com. uriell.malanda@rivm.nl.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 18 JAN 2012

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin.

Objectives

To assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin.

Search methods

Multiple electronic bibliographic and ongoing trial databases were searched supplemented with handsearches of references of retrieved articles (date of last search: 07 July 2011).

Selection criteria

Randomised controlled trials investigating the effects of SMBG compared with usual care, self-monitoring of urine glucose (SMUG) or both in patients with type 2 diabetes who where not using insulin. Studies that used glycosylated haemoglobin A1c (HbA1c) as primary outcome were eligible for inclusion.

Data collection and analysis

Two authors independently extracted data from included studies and evaluated the studies' risk of bias. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. Primary outcomes were HbA1c, health-related quality of life, well-being and patient satisfaction. Secondary outcomes were fasting plasma glucose level, hypoglycaemic episodes, morbidity, adverse effects and costs.

Main results

Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA1c at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group.

There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity.

Authors' conclusions

From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin

Self-monitoring of blood glucose has been found to be effective as a tool in the self-management of patients' glucose levels in people with type 1 diabetes and people with type 2 diabetes using insulin therapy. Patients can use the glucose values to adjust their insulin doses. It is hypothesized that patients with type 2 diabetes who are not using insulin might use the glucose values to adjust their diet and 'lifestyle'. However, there is no consensus on the effect of self-monitoring of blood glucose for type 2 diabetes patients not using insulin. In this systematic review update six new randomised controlled trials were added to the six trials that had been included in the original review. For the comparison of the effect of self-monitoring versus no self-monitoring in patients with a diabetes duration of one year or more 2324 patients with a six months follow-up and 493 patients with a 12 months follow-up were available. Pooled results of studies including patients diagnosed with type 2 diabetes for at least one year show that self-monitoring of blood glucose has a minimal effect in improving glucose control at six months, which disappears after 12 months follow-up. The clinical benefit resulting from this effect is limited.

Two studies reported costs of self-monitoring: One study compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. They concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another study reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group.

We did not find good evidence for an effect on general health-related quality of life, general well-being, patient satisfaction, or on the decrease of the number of hypoglycaemic episodes. However, hypoglycaemic episodes were more often reported in the self-monitoring blood glucose groups than in the control groups (four studies). Because patients in the self-monitoring blood glucose groups can use their device to confirm both periods of asymptomatic and symptomatic hypoglycaemic episodes, this is according to expectations.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

未使用胰島素的第二型糖尿病患的自我血糖監測

自我血糖監測(SMBG)被發現在第一型糖尿病患及使用胰島素的第二型糖尿病患有效果。對於未使用胰島素的第二型糖尿病患使用SMBG為一項自我管理工具的效果則尚有爭議。

目標

這篇文獻的目的在評估SMBG在未使用胰島素的第二型糖尿病患的效果。

搜尋策略

本回顧由多個電子書目資料庫收尋相關研究,另外也以人工針對各研究的參考資料再收取相關文獻。最後搜尋日為2004年9月。

選擇標準

我們收入了在未使用胰島素的第二型糖尿病患比較SMBG與一般照護及/或自我監測尿糖的效果的隨機對照試驗。收入研究至少有下列預後測量的其中之一：血糖控制、生活品質、自我感覺良好、病人滿意、或低血糖發生次數。

資料收集與分析

兩個獨立作者從納入的研究中粹取資料且評估研究的品質。研究資料會被比較並分析其同質性是否足夠加入統合分析。

主要結論

六個隨機對照試驗被納入到此回顧。其中4個試驗比較SMBG與一般照護，1個試驗比較SMBG與自我監測尿糖，另有1個三方分析試驗比較SMBG與自我監測尿糖及一般照護。因為病人基本資料、治療及預後在各個研究不同，統合分析無法執行。在試驗中的統計方法品質是不足的。6個之中有2個研究報告自我監測血糖在降HbA1c上有明顯的效果。然而，其中一個研究有同時介入飲食及生活方式衛教。有少數的資料在看其它預後的效果，但這些結果沒有統計學上的意義。

作者結論

我們在這篇文獻的結論為自我監測血糖可能會改善未使用胰島素的第二型糖尿病患血糖控制。須要大型及設計良好的隨機對照試驗來評估SMBG可能的益處。這類長期的試驗應探討病人相關預後，像自我感覺良好、病人滿意度、及提供適合的衛教讓SMBG產生效果。

翻譯人

本摘要由臺灣大學附設醫院賴瑩純翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

自我監測血糖可能可以改善未使用胰島素的第二型糖尿病患血糖控制。自我血糖監測被發現在第一型糖尿病患及使用胰島素的第二型糖尿病患為一項有效的工具來自我處理病人的血糖值。病人可以使用血糖值來調整他們的胰島素劑量。未使用胰島素的第二型糖尿病患也許可以利用血糖值來調整他們的飲食及生活品質。這篇文獻的結論推測自我監測血糖可能可以改善血糖。但沒有足夠的研究證據顯示對改善生活品質、自我感覺良好、病人滿意度、或減少低血糖發生次數。

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