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針對妊娠糖尿病患者於孕期中不同狀況及環境下的葡萄糖監測方法。

Background

Incidence of gestational diabetes mellitus (GDM) is increasing worldwide. Blood glucose monitoring plays a crucial part in maintaining glycaemic control in women with GDM and is generally recommended by healthcare professionals. There are several different methods for monitoring blood glucose which can be carried out in different settings (e.g. at home versus in hospital).

Objectives

The objective of this review is to compare the effects of different methods and settings for glucose monitoring for women with GDM on maternal and fetal, neonatal, child and adult outcomes, and use and costs of health care.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2016) and reference lists of retrieved studies.

Selection criteria

Randomised controlled trials (RCTs) or quasi‐randomised controlled trials (qRCTs) comparing different methods (such as timings and frequencies) or settings, or both, for blood glucose monitoring for women with GDM.

Data collection and analysis

Two authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy.

We assessed the quality of the evidence for the main comparisons using GRADE, for:

‐ primary outcomes for mothers: that is, hypertensive disorders of pregnancy; caesarean section; type 2 diabetes; and

‐ primary outcomes for children: that is, large‐for‐gestational age; perinatal mortality; death or serious morbidity composite; childhood/adulthood neurosensory disability;

‐ secondary outcomes for mothers: that is, induction of labour; perineal trauma; postnatal depression; postnatal weight retention or return to pre‐pregnancy weight; and

‐ secondary outcomes for children: that is, neonatal hypoglycaemia; childhood/adulthood adiposity; childhood/adulthood type 2 diabetes.

Main results

We included 11 RCTs (10 RCTs; one qRCT) that randomised 1272 women with GDM in upper‐middle or high‐income countries; we considered these to be at a moderate to high risk of bias. We assessed the RCTs under five comparisons. For outcomes assessed using GRADE, we downgraded for study design limitations, imprecision and inconsistency. Three trials received some support from commercial partners who provided glucose meters or financial support, or both.

Main comparisons

Telemedicine versus standard care for glucose monitoring (five RCTs): we observed no clear differences between the telemedicine and standard care groups for the mother, for:

‐ pre‐eclampsia or pregnancy‐induced hypertension (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.69 to 3.20; 275 participants; four RCTs; very low quality evidence);

‐ caesarean section (average RR 1.05, 95% CI 0.72 to 1.53; 478 participants; 5 RCTs; very low quality evidence); and

‐ induction of labour (RR 1.06, 95% CI 0.63 to 1.77; 47 participants; 1 RCT; very low quality evidence);

or for the child, for:

‐ large‐for‐gestational age (RR 1.41, 95% CI 0.76 to 2.64; 228 participants; 3 RCTs; very low quality evidence);

‐ death or serious morbidity composite (RR 1.06, 95% CI 0.68 to 1.66; 57 participants; 1 RCT; very low quality evidence); and

‐ neonatal hypoglycaemia (RR 1.14, 95% CI 0.48 to 2.72; 198 participants; 3 RCTs; very low quality evidence).

There were no perinatal deaths in two RCTs (131 participants; very low quality evidence).

Self‐monitoring versus periodic glucose monitoring (two RCTs): we observed no clear differences between the self‐monitoring and periodic glucose monitoring groups for the mother, for:

‐ pre‐eclampsia (RR 0.17, 95% CI 0.01 to 3.49; 58 participants; 1 RCT; very low quality evidence); and

‐ caesarean section (average RR 1.18, 95% CI 0.61 to 2.27; 400 participants; 2 RCTs; low quality evidence);

or for the child, for:

‐ perinatal mortality (RR 1.54, 95% CI 0.21 to 11.24; 400 participants; 2 RCTs; very low quality evidence);

‐ large‐for‐gestational age (RR 0.82, 95% CI 0.50 to 1.37; 400 participants; 2 RCTs; low quality evidence); and

‐ neonatal hypoglycaemia (RR 0.64, 95% CI 0.39 to 1.06; 391 participants; 2 RCTs; low quality evidence).

Continuous glucose monitoring system (CGMS) versus self‐monitoring of glucose (two RCTs): we observed no clear differences between the CGMS and self‐monitoring groups for the mother, for:

‐ caesarean section (RR 0.91, 95% CI 0.68 to 1.20; 179 participants; 2 RCTs; very low quality evidence);

or for the child, for:

‐ large‐for‐gestational age (RR 0.67, 95% CI 0.43 to 1.05; 106 participants; 1 RCT; very low quality evidence) and

‐ neonatal hypoglycaemia (RR 0.79, 95% CI 0.35 to 1.78; 179 participants; 2 RCTs; very low quality evidence).

There were no perinatal deaths in the two RCTs (179 participants; very low quality evidence).

Other comparisons

Modem versus telephone transmission for glucose monitoring (one RCT): none of the review's primary outcomes were reported in this trial

Postprandial versus preprandial glucose monitoring (one RCT): we observed no clear differences between the postprandial and preprandial glucose monitoring groups for the mother, for:

‐ pre‐eclampsia (RR 1.00, 95% CI 0.15 to 6.68; 66 participants; 1 RCT);

‐ caesarean section (RR 0.62, 95% CI 0.29 to 1.29; 66 participants; 1 RCT); and

‐ perineal trauma (RR 0.38, 95% CI 0.11 to 1.29; 66 participants; 1 RCT);

or for the child, for:

‐ neonatal hypoglycaemia (RR 0.14, 95% CI 0.02 to 1.10; 66 participants; 1 RCT).

There were fewer large‐for‐gestational‐age infants born to mothers in the postprandial compared with the preprandial glucose monitoring group (RR 0.29, 95% CI 0.11 to 0.78; 66 participants; 1 RCT).

Authors' conclusions

Evidence from 11 RCTs assessing different methods or settings for glucose monitoring for GDM suggests no clear differences for the primary outcomes or other secondary outcomes assessed in this review.

However, current evidence is limited by the small number of RCTs for the comparisons assessed, small sample sizes, and the variable methodological quality of the RCTs. More evidence is needed to assess the effects of different methods and settings for glucose monitoring for GDM on outcomes for mothers and their children, including use and costs of health care. Future RCTs may consider collecting and reporting on the standard outcomes suggested in this review.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

針對妊娠糖尿病孕婦於孕期中不同狀況及環境下的葡萄糖監測方法。

此文獻回顧宗旨為何?

妊娠糖尿病 (GDM) 為一葡萄糖耐受不良症狀,其會導致在妊娠初期或期間初次發現,血液中具有高濃度的葡萄糖 (醣) (高血糖症)。監測血糖為維持血糖控制之重要方式。在不同環境下(如:在家自我監測或至醫院檢測),監測血糖的方法有許多,然而目前尚不清楚哪些方法最能減少影響母親及胎兒健康的併發症。

為何此議題很重要?

罹患妊娠糖尿病的婦女,在懷孕期間有較高的可能性會發生子癇前症( 以高血壓為特徵的危險狀況 )、提早終止妊娠、生產過程中會陰部受傷或剖腹生產。妊娠糖尿病母親所產下的新生兒可能會發生巨嬰症、血糖低(低血糖症)及產生致死性的併發症。母親與嬰兒皆有可能產生影響長期健康的併發症, 包括第二型糖尿病。

我們找到了哪些證據?

我們在2016年9月搜索了醫學文獻, 包括11個隨機對照試驗 (RCTs),1272名妊娠糖尿病婦女及其嬰兒。三個試驗是由商業合作夥伴贊助。

我們納入五種不同的比較:

1) 遠距醫療 (可將血糖數據從居家傳送至醫療院所專業人員) 與標準照護之比較 (門診/醫院面對面就診) (五個隨機對照試驗);

2) 自我血糖監測 (居家) 與定期血糖監測之比較 (頻率較低之面對面就診) (兩個隨機對照試驗);

3) 使用連續式血糖監測儀 (CCMS) 與監測頻率較低的自我血糖監測之比較 (兩個隨機對照試驗);

4) 現代通訊數據技術 (血糖數據直接經由血糖機傳送至專業醫療人員) 與以電話告知醫療人員血糖數據之比較 (一個隨機對照試驗);

5)飯後血糖監測(用餐後) 與飯前血糖監測(用餐前) 之比較 (一個隨機對照試驗)。

血糖監測之遠距醫療與標準照護比較(五個隨機對照試驗): 接受遠距醫療或標準照護之受試組別婦女, 其產生子癇前症或高血壓、剖腹產或引產;新生兒大於其胎齡、嚴重併發症或低血糖, 兩組並無明顯差異。兩個隨機對照試驗中皆無嬰兒死亡的案例。

自我血糖監測與定期血糖監測之比較 (兩個隨機對照試驗): 接受自我血糖監測或定期血糖監測之受試組別婦女,其發生子癇前症或剖腹;新生兒死亡、新生兒大於其胎齡、或低血糖,兩組並無明顯差異。

連續式血糖監測儀(CGMS)與自我血糖監測之比較 (兩個隨機對照試驗): 使用CGMS監測血糖或自我監測血糖之受試組別婦女,其發生剖腹;新生兒大於其胎齡或低血糖,兩組並無明顯差異。兩個隨機對照試驗中,並無嬰兒死亡的案例。

現代通訊數據技術與電話告知醫療人員血糖數據之比較 (一個隨機對照試驗): 這個隨機對照試驗報告內容中並無提及任何我們認為重要的結果。

飯後血糖監測與飯前血糖監測之比較 ( 一個隨機對照試驗 ) : 接受飯後血糖監測或飯前血糖監測之受試組別婦女,其發生子癇前症、剖腹或會陰創傷;或嬰兒低血糖,兩組並無明顯差異。監測飯後血糖組別之婦女,其新生兒出現大於胎齡的機率低於監測飯前血糖組別之婦女。

上述結果的證據品質為低或非常低。11個隨機對照試驗均未報導關於產後憂鬱症、產後婦女體重滯留、產後恢復至產前體重、或罹患第二型糖尿病;或殘疾、肥胖、或出生之嬰兒於孩童或成人時期罹患第二型糖尿病之研究報告。

這些資料代表的意思?

血糖監測是管控妊娠糖尿病 (GDM) 的一項重要策略, 但目前尚不清楚哪些監測方法是最好的。雖然已對一系列的方法進行調查, 但隨機對照試驗之結果尚未有確鑿的證據可用於實務指引中。比較相同或相似介入措施的隨機對照試驗數較少, 隨機對照試驗之規模較小, 且報告結果侷限。為了改善短期及長期妊娠糖尿病婦女及嬰兒面臨的問題及結果,需進一步進行大規模、精心設計的隨機對照試驗, 以評估不同血糖監測方法及環境對於妊娠期糖尿病婦女的影響。