OBJECTIVE: This study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes.
DESIGN: This was a pragmatic 52-week cluster-randomized controlled study among 11 primary care government practices in Malaysia.
PARTICIPANTS: People with type 2 diabetes aged 18 and above, who had hemoglobin A1c ≥ 7.5% but less than 11.0% within the past 3 months and resided in the state of Selangor.
INTERVENTION: The intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated self-management by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service.
MAIN MEASURE: The primary outcome was the change in HbA1c at 24 weeks and 52 weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy.
RESULTS: A total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, - 0.05%; 95% CI - 0.10 to 0.00%) and at follow-up (week 52, - 0.03%; - 0.07 to 0.02%, p = 0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life.
CONCLUSION: This study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02466880.
OBJECTIVES: To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), searched reference lists of retrieved studies and contacted trial authors.
SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM) or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also included. RCTs using a cluster-randomised design were eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: This review update includes at total of 10 trials (538) women (468 women with type 1 diabetes and 70 women with type 2 diabetes). The trials took place in Europe and the USA. Five of the 10 included studies were at moderate risk of bias, four studies were at low to moderate risk of bias, and one study was at high risk of bias. The trials are too small to show differences in important outcomes such as macrosomia, preterm birth, miscarriage or death of baby. Almost all the reported GRADE outcomes were assessed as being very low-quality evidence. This was due to design limitations in the studies, wide confidence intervals, small sample sizes, and few events. In addition, there was high heterogeneity for some outcomes.Various methods of glucose monitoring were compared in the trials. Neither pooled analyses nor individual trial analyses showed any clear advantages of one monitoring technique over another for primary and secondary outcomes. Many important outcomes were not reported.1. Self-monitoring versus standard care (two studies, 43 women): there was no clear difference for caesarean section (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.40 to 1.49; one study, 28 women) or glycaemic control (both very low-quality), and not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Hypertensive disorders of pregnancy, large-for-gestational age, neurosensory disability, and preterm birth were not reported in either study.2. Self-monitoring versus hospitalisation (one study, 100 women): there was no clear difference for hypertensive disorders of pregnancy (pre-eclampsia and hypertension) (RR 4.26, 95% CI 0.52 to 35.16; very low-quality: RR 0.43, 95% CI 0.08 to 2.22; very low-quality). There was no clear difference in caesarean section or preterm birth less than 37 weeks' gestation (both very low quality), and the sample size was too small to assess perinatal mortality (very low-quality). Large-for-gestational age, mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.3. Pre-prandial versus post-prandial glucose monitoring (one study, 61 women): there was no clear difference between groups for caesarean section (RR 1.45, 95% CI 0.92 to 2.28; very low-quality), large-for-gestational age (RR 1.16, 95% CI 0.73 to 1.85; very low-quality) or glycaemic control (very low-quality). The results for hypertensive disorders of pregnancy: pre-eclampsia and perinatal mortality are not meaningful because these outcomes were too rare to show differences in a small sample (all very low-quality). The study did not report the outcomes mortality or morbidity composite, neurosensory disability or preterm birth.4. Automated telemedicine monitoring versus conventional system (three studies, 84 women): there was no clear difference for caesarean section (RR 0.96, 95% CI 0.62 to 1.48; one study, 32 women; very low-quality), and mortality or morbidity composite in the one study that reported these outcomes. There were no clear differences for glycaemic control (very low-quality). No studies reported hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), neurosensory disability or preterm birth.5.CGM versus intermittent monitoring (two studies, 225 women): there was no clear difference for pre-eclampsia (RR 1.37, 95% CI 0.52 to 3.59; low-quality), caesarean section (average RR 1.00, 95% CI 0.65 to 1.54; I² = 62%; very low-quality) and large-for-gestational age (average RR 0.89, 95% CI 0.41 to 1.92; I² = 82%; very low-quality). Glycaemic control indicated by mean maternal HbA1c was lower for women in the continuous monitoring group (mean difference (MD) -0.60 %, 95% CI -0.91 to -0.29; one study, 71 women; moderate-quality). There was not enough evidence to assess perinatal mortality and there were no clear differences for preterm birth less than 37 weeks' gestation (low-quality). Mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.6. Constant CGM versus intermittent CGM (one study, 25 women): there was no clear difference between groups for caesarean section (RR 0.77, 95% CI 0.33 to 1.79; very low-quality), glycaemic control (mean blood glucose in the 3rd trimester) (MD -0.14 mmol/L, 95% CI -2.00 to 1.72; very low-quality) or preterm birth less than 37 weeks' gestation (RR 1.08, 95% CI 0.08 to 15.46; very low-quality). Other primary (hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), mortality or morbidity composite, and neurosensory disability) or GRADE outcomes (preterm birth less than 34 weeks' gestation) were not reported.
AUTHORS' CONCLUSIONS: This review found no evidence that any glucose monitoring technique is superior to any other technique among pregnant women with pre-existing type 1 or type 2 diabetes. The evidence base for the effectiveness of monitoring techniques is weak and additional evidence from large well-designed randomised trials is required to inform choices of glucose monitoring techniques.
Methodology: We conducted a cross-sectional study using 6-days CGMS to detect the prevalence of hypoglycaemia in 31 insulin-treated pregnant women with diabetes who achieved HbA1c <6.0%. Patients were required to log-keep their self-monitoring blood glucose (SMBG) readings and hypoglycaemia events.
Results: Eight women experienced confirmed hypoglycaemia with additional seven experienced relative hypoglycaemia, giving rise to prevalence rate of 45.2% (one had both confirmed and relative hypoglycaemia). Nine relative hypoglycaemia and 17 confirmed hypoglycaemic events were recorded. Sixteen (94%) out of 17 confirmed hypoglycaemia events recorded by CGMS were asymptomatic and were missed despite performing regular SMBG. Nocturnal hypoglycaemia events were recorded in seven women. Univariable analysis did not identify any association between conventional risk factors and hypoglycaemia events in our cohort.
Conclusion: Insulin-treated pregnant women with diabetes who achieved HbA1c <6.0% were associated with high prevalence of hypoglycaemia. Asymptomatic hypoglycaemia is common in our cohort and frequently missed despite regular SMBG. Present study did not identify any association between conventional risk factors and hypoglycaemia events in our cohort.