Methods: The Iraqi Anti-Diabetic Medication Adherence Scale (IADMAS) consists of eight items. The face and content validity of the IADMAS were established via an expert panel. For convergent validity, the IADMAS was compared with the Medication Adherence Questionnaire (MAQ). For concurrent validity, the IADMAS was compared with glycosylated hemoglobin. A total of 84 patients with types 2 diabetes were recruited from a diabetes center in Baghdad, Iraq. Test-retest reliability was measured by readministering the IADMAS to the same patients 4 weeks later.
Results: Only 80 patients completed the study (response rate: 95%). Reliability analysis of the IADMAS showed a Cronbach's alpha value of 0.712, whereas that of the MAQ was 0.649. All items in the IADMAS showed no significant difference in the test-retest analysis, indicating that the IADMAS has stable reliability. There was no difference in the psychometric properties of the IADMAS and the MAQ. The sensitivity and specificity of the IADMAS were higher than that of the MAQ (100% vs 87.5% and 33.9% vs 29.7%, respectively).
Conclusion: The IADMAS developed in this study is a reliable and valid instrument for assessing antidiabetic medication adherence among Iraqi patients.
METHODS: Demographic and clinical variables were assessed at baseline, after three and six months in 73 type 2 diabetes patients. Regression analysis, using SPSS, evaluated the concurrent and longitudinal association of medication adherence and glycemic control. Potential confounders of variables were identified using bi-variate correlation analyses.
RESULTS: Concurrent Medication adherence and HbA1c association were significant after adjusting for ethnicity (P = 0.005). For longitudinal observation at 3 months, the association was significant after adjusting for ethnicity (P = 0.016); however, it became non-significant when baseline glycemic control was included in the model (P = 0.28).
CONCLUSION: Easy to administer MALMAS significantly predicted concurrent glycemic control independent of potential confounders. This association persisted in longitudinal observation after 3 months when adjusted for confounders and became non-significant after adjusting for baseline glycemic control.
METHODS: A 6-month parallel multicenter two-arm, single-blind randomized controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialized diabetes training were trained to use the tool. Patients were randomized within each center to either Simpler care (SC), receiving care from pharmacists who used the tool (n =55), or usual care (UC), receiving usual care and dispensing services (n = 69).
RESULTS: Compared with UC, SC significantly reduced HbA1c (mean reduction 1.59% [95% confidence interval {CI} -2.2, -0.9] vs 0.25% [95% CI -0.62, 0.11], respectively; P ≤ 0.001), and significantly improved systolic BP (-6.28 mmHg [95% CI -10.5, 2.0] vs 0.26 mmHg [95% CI -3.74, 0.43], respectively; P = 0.005). A significantly higher proportion of patients in the SC than UC arm reached the Malaysian guideline treatment goals for HbA1c (14.3% vs 1.5%; P = 0.020), systolic BP (80% vs 42%; P = 0.001), and low-density lipoprotein cholesterol (60.5% vs 40.4%; P = 0.046).
CONCLUSIONS: Using the Simpler tool facilitated the delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler tool supported pharmacists in providing enhanced structured diabetes care.
METHODS: A total of 1065 patients aged ≥18 years with T2DM initiating insulin therapy in normal clinical course were enrolled from Hong Kong, Malaysia, Philippines, Taiwan and Thailand. Participants' data was recorded by the treating physicians. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants.
RESULTS: The mean age of patients was 57.2 years with mean glycosylated hemoglobin (HbA1c) of 10.0%. About 66% of patients had an HbA1c ≥9.0% at insulin initiation despite 74% of them being on two or more oral antidiabetic agents at the time of insulin initiation. Basal insulin was initiated in 72% and premixed insulin in 27% of patients. Changes in insulin therapy was observed in 63% of patients and, by the end of study, 28% achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment increased over the study course and the quality of life (QoL) score increased from baseline to the study end.
CONCLUSION: As high HbA1C levels indicate a delayed start of insulin therapy, timely initiation and early intensification of insulin therapy is necessary in the region to achieve adequate glycemic control in time and prevent diabetes complications. Data from PROs suggests that the insulin treatment improves QoL in most patients.
METHODS: This is a controlled, intervention based study. It was run on three phases: before, during, and after Ramadan on 262 type 2 diabetes patients. The intervention group (n = 140) received RFEP on medications doses & timing adjustment before and after Ramadan, while the control group (n = 122) received standard care.
RESULTS: The dose of insulin glargine was reduced from 42.51 ± 22.16 at the baseline to 40.11 ± 18.51-units during Ramadan (p = 0.002) in the intervention group while it remained the same in the control group before Ramadan and during Ramadan (38.51 ± 18.63 and 38.14 ± 18.46, P = 0.428, respectively). The hypoglycemia score was 14.2 ± (8.5) pre-Ramadan in the intervention and reduced to 6.36 ± 6.17 during Ramadan (p
METHODS: This prospective, randomized controlled, open-label trial evaluated 50 women with insulin-treated GDM randomized to either retrospective CGM (6-day sensor) at 28, 32 and 36 weeks' gestation (Group 1, CGM, n = 25) or usual antenatal care without CGM (Group 2, control, n = 25). All women performed seven-point capillary blood glucose (CBG) profiles at least 3 days per week and recorded hypoglycaemic events (symptomatic and asymptomatic CBG
METHODS: The e-intervention group (n = 62) received a 6-month web-delivered intensive dietary intervention while the control group (n = 66) continued with their standard hospital care. Outcomes (DKAB and DSOC scores, FBG and HbA1c) were compared at baseline, post-intervention and follow-up.
RESULTS: While both study groups showed improvement in total DKAB score, the margin of improvement in mean DKAB score in e-intervention group was larger than the control group at post-intervention (11.1 ± 0.9 vs. 6.5 ± 9.4,p
METHODS: A retrospective observational study of 60 type 1 and 100 type 2 diabetes subjects. All underwent professional continuous glucose monitoring (CGM) for 3-6 days and recorded self-monitored blood glucose (SMBG). Indices were calculated from both CGM and SMBG. Statistical analyses included regression and area under receiver operator curve (AUC) analyses.
RESULTS: Hypoglycemia frequency (53.3% vs. 24%, P
METHODS: We randomized 108 overweight and obese patients with T2D (46 M/62F; age 60 ± 10 years; HbA1c 8.07 ± 1.05%; weight 101.4 ± 21.1 kg and BMI 35.2 ± 7.7 kg/m2) into three groups. Group A met with RDN to develop an individualized eating plan. Group B met with RDN and followed a structured meal plan. Group C did similar to group B and received weekly phone support by RDN.
RESULTS: After 16 weeks, all three groups had a significant reduction of their energy intake compared to baseline. HbA1c did not change from baseline in group A, but decreased significantly in groups B (- 0.66%, 95% CI -1.03 to - 0.30) and C (- 0.61%, 95% CI -1.0 to - 0.23) (p value for difference among groups over time
MATERIALS AND METHODS: A total of 100 type 2 diabetes participants with stage 3-4 CKD were recruited. Blood for glycated hemoglobin (HbA1c ), serum 25(OH)D, renal and lipid profiles were drawn at enrollment. Correlation and regression analyses were carried out to assess the relationship of serum 25(OH)D, HbA1c and other metabolic traits.
RESULTS: A total of 30, 42, and 28% of participants were in CKD stage 3a, 3b and 4, respectively. The proportions of participants based on ethnicity were 51% Malay, 24% Chinese and 25% Indian. The mean (±SD) age and body mass index were 60.5 ± 9.0 years and 28.3 ± 5.9 kg/m2 , whereas mean HbA1c and serum 25(OH)D were 7.9 ± 1.6% and 37.1 ± 22.2 nmol/L. HbA1c was negatively correlated with serum 25(OH)D (rs = -0.314, P = 0.002), but positively correlated with body mass index (rs = 0.272, P = 0.006) and serum low-density lipoprotein cholesterol (P = 0.006). There was a significant negative correlation between serum 25(OH)D and total daily dose of insulin prescribed (rs = -0.257, P = 0.042). Regression analyses showed that every 10-nmol/L decline in serum 25(OH)D was associated with a 0.2% increase in HbA1c .
CONCLUSIONS: Lower serum 25(OH)D was associated with poorer glycemic control and higher insulin use among multi-ethnic Asians with type 2 diabetes and stage 3-4 CKD.
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.
PATIENTS & METHODS: DPP4, WFS1 and KCNJ11 gene polymorphisms were genotyped in a cohort study of 662 T2DM patients treated with DPP-4 inhibitors sitagliptin, vildagliptin or linagliptin. Genotyping was performed by Applied Biosystems TaqMan SNP genotyping assay.
RESULTS: Patients with triglyceride levels less than 1.7 mmol/l (odds ratio [OR]: 2.2.; 95% CI: 1.031-4.723), diastolic blood pressure (DBP) less than 90 mmHg (OR: 1.7; 95% CI: 1.009-2.892) and KCNJ11 rs2285676 (genotype CC) (OR: 2.0; 95% CI: 1.025-3.767) were more likely to response to DPP-4 inhibitor treatment compared with other patients, as measured by HbA1c levels.
CONCLUSION: Triglycerides, DBP and KCNJ11 rs2285676 are predictors of the DPP-4 inhibitor treatment response in T2DM patients.