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

 

Abstract

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 A_1c (HbA_1c) 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 HbA_1c, 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 HbA_1c 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

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.

 

Résumé

Autosurveillance de la glycémie chez les patients atteints de diabète de type 2 non insulino-dépendants

Contexte

L'autosurveillance de la glycémie (ASG) s'est révélée efficace chez les patients atteints de diabète de type 1 et de type 2 insulino-dépendants. L'efficacité de l'ASG comme outil servant à l'autogestion des patients atteints de diabète de type 2 non insulino-dépendants fait l'objet de nombreux débats.

Objectifs

Évaluer les effets de l'autosurveillance de l'ASG chez les patients atteints de diabète de type 2 non insulino-dépendants.

Stratégie de recherche documentaire

Plusieurs bases de données d'essais en cours et bibliographiques électroniques ont fait l'objet de recherches auxquelles se sont ajoutées des recherches manuelles dans les bibliographies ou les articles extraits (date de la dernière recherche : 7 juillet 2011).

Critères de sélection

Des essais contrôlés randomisés étudiant les effets de l'ASG comparés à des soins habituels, l'autosurveillance du glucose dans les urines (ASGU) chez des patients atteints de diabète de type 2 non insulino-dépendants. Les études utilisant l'hémoglobine glycosylée A_1c (HbA_1c) comme critère principal étaient éligibles pour l'inclusion.

Recueil et analyse des données

Deux auteurs ont extrait des données des études incluses et évalué leurs risques de biais de façon indépendante. Ces données étaient comparées afin de déterminer si elles étaient suffisamment homogènes pour les regrouper dans une méta-analyse. Les critères principaux étaient HbA_1c, la qualité de vie liée à la santé, le bien-être et la satisfaction du patient. Les critères secondaires étaient le niveau de glycémie plasmatique à jeun, les épisodes d'hypoglycémie, la morbidité, les effets indésirables et les coûts.

Résultats Principaux

Douze essais contrôlés randomisés étaient inclus et évaluaient ces critères auprès de 3 259 patients randomisés. La durée de l'intervention variait de 6 mois (26 semaines) à 12 mois (52 semaines). Neuf essais comparaient l'ASG à des soins habituels sans surveillance, une étude comparait l'ASG à l'ASGU, une étude correspondait à un essai composé de trois bras comparant l'ASG et l'ASGU à des soins habituels et une étude correspondait à un essai composé de trois bras comparant une ASG moins intensive et une ASG plus intensive à un groupe témoin. Sept études sur 11 présentaient de faibles risques de biais pour la majorité des indicateurs. Une méta-analyse des études incluant des patients atteints de diabète depuis au moins un an révélait une baisse induite de l'ASG statistiquement significative de l'HbA_1c au bout de six mois de suivi (- 0,3 ; intervalle de confiance (IC) à 95 % - 0,4 à - 0,1 ; 2 324 participants, neuf essais). Cependant, une baisse induite globale de l'ASG non significative statistiquement était constatée au bout de 12 mois de suivi (- 0,1 ; IC à 95 % - 0,3 à 0,04 ; 493 participants, deux essais). Des analyses qualitatives portant sur les effets de l'ASG sur le bien-être et la qualité de vie n'ont révélé aucun effet sur la satisfaction du patient, le bien-être général ou la qualité de vie liée à la santé générale. Deux études faisaient état des coûts de l'autosurveillance : Un essai comparait les coûts de l'autosurveillance de la glycémie à l'autosurveillance du glucose dans les urines en se basant sur neuf mesures hebdomadaires et dont les sommes étaient exprimées en dollars américains pour l'autosurveillance en 1990. Les auteurs ont conclu que les coûts totaux pour la première année d'autosurveillance de la glycémie, avec l'achat d'un photomètre à réflectance, étaient 12 fois supérieurs par rapport à l'autosurveillance du glucose dans les urines (481 $ ou 361 EUROS [conversion de 11/2011] contre 40 $ ou 30 EUROS [conversion de 11/2011]). Un autre essai faisait état d'une évaluation économique totale des coûts et des effets de l'autosurveillance. À la fin de l'essai, les coûts de l'intervention s'élevaient à 89 £ (104 EUROS [conversion de 11/2011]) pour des soins habituels standardisés (groupe témoin), 181 £ (212 EUROS [conversion de 11/2011]) pour le groupe d'autosurveillance la moins intensive et 173 £ (203 EUROS [conversion de 11/2011]) pour le groupe d'autosurveillance la plus intensive. Des pertes de vue importantes dans le groupe d'autosurveillance la plus intensive étaient responsables des différences de coûts, comparées au groupe d'autosurveillance la moins intensive.

Peu de données portant sur les effets sur d'autres critères de résultat étaient disponibles et ces effets n'étaient pas statistiquement significatifs. Aucune de ces études ne disposaient de données sur la morbidité.

Conclusions des auteurs

Cette revue nous permet de conclure que lorsque la durée du diabète dépasse un an, les effets globaux de l'autosurveillance de la glycémie sur le contrôle glycémique chez des patients atteints de diabète de type 2 non insulino-dépendants sont minimes 6 mois après le début du traitement et disparaissent au bout de 12 mois. Par ailleurs, en se basant sur une synthèse des meilleures preuves, aucune n'a permis de démontrer que l'ASG a un effet sur la satisfaction des patients, le bien-être général ou la qualité de vie liée à la santé générale. Des recherches supplémentaires doivent être effectuées pour examiner l'impact psychologique de l'ASG et son impact sur ​​la qualité de vie et le bien-être en rapport avec le diabète, ainsi que l'impact de l'ASG sur l'hypoglycémie et les complications diabétiques.

 

Résumé simplifié

Autosurveillance de la glycémie chez les patients atteints de diabète de type 2 non insulino-dépendants

Autosurveillance de la glycémie chez les patients atteints de diabète de type 2 non insulino-dépendants

L'autosurveillance de la glycémie se révèle efficace comme outil d'autogestion des niveaux de glycémie chez des patients atteints de diabète de type 1 et de type 2 utilisant l'insulinothérapie. Les patients peuvent utiliser les valeurs glycémiques pour régler leurs doses d'insuline. On suppose que les patients atteints de diabète de type 2 qui n'utilisent pas l'insuline peuvent avoir recours aux valeurs glycémiques pour adapter leur régime alimentaire et leur « style de vie ». Toutefois, il n'existe aucun consensus sur les effets de l'autosurveillance de la glycémie chez les patients atteints de diabète de type 2 non insulino-dépendants. Dans la mise à jour de cette revue systématique, six nouveaux essais contrôlés randomisés ont été ajoutés aux six essais inclus dans la revue d'origine. Pour la comparaison des effets de l'autosurveillance à l'absence d'autosurveillance chez les patients atteints de diabète depuis au moins un an, 2 324 patients suivis pendant 6 mois et 493 patients suivis pendant 12 mois étaient disponibles. Les résultats regroupés des études, incluant des patients diagnostiqués avec un diabète de type 2 depuis au moins un an, révèlent que l'autosurveillance de la glycémie a un effet minime sur l'amélioration du contrôle de la glycémie au bout de six mois et disparaît après un suivi de 12 mois. Les avantages cliniques résultant de cet effet sont limités.

Deux études évoquaient les coûts de l'autosurveillance : Une étude comparait les coûts de l'autosurveillance de la glycémie à l'autosurveillance du glucose dans les urines en se basant sur neuf mesures hebdomadaires et dont les sommes étaient exprimées en dollars américains pour l'autosurveillance en 1990. Il a été conclu que les coûts totaux pour la première année d'autosurveillance de la glycémie, avec l'achat d'un photomètre à réflectance, étaient 12 fois supérieurs par rapport à l'autosurveillance du glucose dans les urines (481 $ ou 361 EUROS [conversion de 11/2011] contre 40 $ ou 30 EUROS [conversion de 11/2011]). Une autre étude faisait état d'une évaluation économique totale des coûts et des effets de l'autosurveillance. À la fin de l'essai, les coûts de l'intervention s'élevaient à 89 £ (104 EUROS [conversion de 11/2011]) pour des soins habituels standardisés (groupe témoin), 181 £ (212 EUROS [conversion de 11/2011]) pour le groupe d'autosurveillance la moins intensive et 173 £ (203 EUROS [conversion de 11/2011]) pour le groupe d'autosurveillance la plus intensive.

Nous n'avons trouvé aucune preuve probante révélant un effet sur la qualité de vie liée à la santé générale, le bien-être général, la satisfaction du patient ou sur la baisse du nombre d'épisodes hypoglycémiques. Toutefois, ces derniers se produisaient plus souvent dans les groupes d'autosurveillance de la glycémie que dans les groupes témoin (quatre études), car les patients des groupes d'autosurveillance de la glycémie pouvaient utiliser leur dispositif pour confirmer les périodes des épisodes hypoglycémiques symptomatiques et asymptomatiques, conformément aux attentes.

Notes de traduction

This translation refers to an older version of the review that has been updated or amended.

Traduit par: French Cochrane Centre 10th April, 2012
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

 

Abstract

Samostalno praćenje glukoze u krvi u bolesnika s dijabetesom tipa 2 koji ne koriste inzulin

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 A_1c (HbA_1c) 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 HbA_1c, 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 HbA_1c 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

Samostalno praćenje glukoze u krvi u bolesnika s dijabetesom tipa 2 koji ne koriste inzulin

Samostalno praćenje glukoze u krvi u bolesnika s dijabetesom tipa 2 koji ne koriste inzulin

Samostalno praćenje glukoze u krvi učinkovito je kao alat u samokontroli razine glukoze u pacijenata s dijabetesom tipa 1 i pacijenata s dijabetesom tipa 2 koji koriste inzulinsku terapiju. Pacijenti mogu koristiti vrijednosti glukoze za prilagođavanje svoje doze inzulina. Pretpostavlja se da bolesnici s dijabetesom tipa 2 koji ne koriste inzulin, mogu koristiti vrijednosti glukoze kako bi prilagodili svoju prehranu i način života. Međutim, ne postoji konsenzus o utjecaju samostalnog praćenja glukoze u krvi za bolesnike s dijabetesom tipa 2 koji ne koriste inzulin. U ovom obnovljenom sustavnom pregledu, šest novih randomiziranih kontroliranih pokusa analizirano je zajedno sa šest studija koje su bila uključene u izvorni sustavni pregled. Za usporedbu učinka samostalnog praćenja naspram odsustva samostalnog praćenja u bolesnika s dijabetesom u trajanju od jedne ili više godina bili su dostupni podaci za 2.324 bolesnika koji su praćeni šest mjeseci i 493 bolesnika praćenih 12 mjeseci. Skupni rezultati studija, uključujući pacijente s dijagnosticiranim dijabetesom tipa 2 za najmanje jednu godinu pokazuju da samostalno praćenje glukoze u krvi ima minimalan učinak u poboljšanju kontrole glukoze tijekom šest mjeseci, koji se gubi nakon 12 mjeseci praćenja. Klinička korist koja proizlazi iz tog djelovanja je ograničena.

Dvije studije su izvijestile o troškovima samostalnog praćenja razine glukoze: Jedna studija je usporedila troškove samostalnog praćenja glukoze u krvi sa samostalnim praćenjem glukoze u urinu temeljeno na devet mjerenja tjedno i s cijenama u američkim dolarima za samostalno praćenje u 1990. godini. Zaključili su da su ukupni troškovi u prvoj godini samostalnog praćenja glukoze u krvi, uz kupnju mjernog uređaja, 12 puta veći od samostalnog praćenja glukoze u urinu (481 USD ili 361 EUR [tečajna lista 11/2011] u odnosu na 40 USD ili 30 EUR [tečajna lista 11/2011]). Druga studija je napravila punu ekonomsku procjenu troškova i učinaka samostalnog praćenja. Na kraju pokusa, troškovi za intervencije su bili 89 GBP (104 EUR [tečajna lista 11/2011]) za standardiziranu uobičajenu njegu (kontrolna skupina), 181 GBP (212 EUR [tečajna lista 11/2011]) za manje intenzivno samostalno praćenje i 173 GBP (203 EUR [tečajna lista 11/2011]) za skupinu s intenzivnijim samostalnim praćenjem.

Nisu pronađeni dovoljno dobri dokazi o utjecaju samostalnog mjerenja glukoze u krvi na opću zdravstvenu kvalitetu života, opće zdravlje, zadovoljstvo pacijenta ili na smanjenje broja hipoglikemijskih epizoda. Međutim, hipoglikemijske epizode su bile češće u skupinama ispitanika koje su samostalno pratile glukozu u krvi, nego u kontrolnim skupinama (četiri studije). Budući da bolesnici u skupinama koje su samostalno pratile glukozu u krvi mogu koristiti svoje uređaje za potvrdu oba razdoblja simptomatskih i asimptomatskih hipoglikemijskih epizoda, ovo je u skladu s očekivanjima.

Translation notes

Translated by: Croatian Branch of the Italian Cochrane Centre
Translation Sponsored by: Ministry of Education, Science and Sports