Development and Validation of USM-Insulin Adherence Module for Patients with Type 2 Diabetes Mellitus.

Background: Many patients with type 2 diabetes mellitus (T2DM) do not achieve the desired glycaemic control despite being treated with insulin. Studies found this due to an improper understanding of insulin function, its intensification process and patients' negative perspective on insulin. We developed an education module to enhance adherence to insulin therapy. Methods: This study applied a mixed design. It was conducted in three phases: i) Phase I: literature search and focus group discussions (FGDs), ii) Phase II: module development and iii) Phase III: content and face validation of Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM). FGDs were used to gather patients' opinions. All researchers repeatedly discussed about the module content and arrangement, the words and images used, and the grammar in producing the final draft. Specialists and target audience performed content and face validation of the module. Results: Thirty-six participants were involved in the FGDs. Data saturation was achieved at the 4th FGD. Three themes emerged from qualitative data analysis and were incorporated into the module. USM-IAM was finalised with five units. The content validity index (CVI) was 0.92, while face validity agreements were between 86% and 97%. Conclusion: The CVI and face agreement for USM-IAM exceed the cut-off point for a sound module. It has good potential to be used as a resource for educating patients in enhancing insulin adherence.

Evaluating the Impact of Intensifying Treatment from Human to Analogue Insulin on Glycaemic Control and Insulin Expenditure in Patients with Type 2 Diabetes: A Retrospective Cohort Study.

Background: Achieving good glycaemic control is essential to reducing the risk of diabetes complications. Insulin is the most effective therapy for achieving good glycaemic control; however, it is associated with a higher risk of hypoglycaemia, especially with human insulin. This study aimed to evaluate the efficacy of intensification from human to analogue insulin and its added cost. Methods: This retrospective study was conducted at the Hospital Universiti Sains Malaysia (HUSM). Patients with type 2 diabetes mellitus (T2DM) who underwent intensification for at least 3 months from human to analogue insulin were included in this study. The patients' medical records, haemoglobin A1c (Hba1c) and fasting blood sugar (FBS) were retrieved. The total cost pre- and post-intensification of insulin was obtained from the pharmacy database. Differences in HbA1c, FBS and total insulin cost pre- and post-intensification were analysed. Results: A total of 163 patients with T2DM who had intensification from human to analogue insulin were included in this study. HbA1c and FBS levels were significantly lower in analogue insulin. However, the differences were not clinically significant, as the mean reduction in HbA1c was less than 0.5%. Meanwhile, the total costs of analogue insulin for 3 months were higher. Conclusion: There were no clinically significant improvements in patients' HbA1c and FBS after the intensification of insulin, despite the extra costs spent. Hence, it is vital to choose the right group of patients to receive an insulin analogue to maximise its benefit but at the most optimal cost.

Association between Vitamin D Receptor Polymorphisms (BsmI and FokI) and Glycemic Control among Patients with Type 2 Diabetes.

(1) Background: Several studies have suggested that the vitamin D receptor (VDR) gene plays a role in type 2 diabetes mellitus (T2DM) susceptibility. Nonetheless, the association between T2DM and VDR polymorphisms remains inconclusive. We determined the genotype of VDR rs1544410 (BsmI) and rs2228570 (FokI) polymorphisms among Malaysian patients with T2DM and their association with glycemic control factors (vitamin D levels, calcium, magnesium, and phosphate). (2) Methods: A total of 189 participants comprising 126 patients with T2DM (63 with good glycemic control and 63 with poor glycemic control) and 63 healthy controls were enrolled in this case-control study. All biochemical assays were measured using spectrophotometric analysis. VDR gene FokI and BsmI polymorphisms were analyzed using polymerase chain reaction and endonuclease digestion. (3) Results: Our findings revealed no significant differences in VDR FokI and BsmI genotypes between participants with T2DM and healthy controls. Moreover, no significant association was observed between both single nucleotide polymorphisms and glycemic control factors. Participants with poor glycemic control had significantly lower serum magnesium levels and significantly higher HOMA-IR compared to the other groups. (4) Conclusions: The present study revealed that VDR gene BsmI and FokI polymorphisms were not significantly associated with T2DM.

Comparison of Vitamin D Levels, Bone Metabolic Marker Levels, and Bone Mineral Density among Patients with Thyroid Disease: A Cross-Sectional Study.

Thyroid hormones have a catabolic effect on bone homeostasis. Hence, this study aimed to evaluate serum vitamin D, calcium, and phosphate and bone marker levels and bone mineral density (BMD) among patients with different thyroid diseases. This cross-sectional study included patients with underlying thyroid diseases (n = 64, hyperthyroid; n = 53 euthyroid; n = 18, hypothyroid) and healthy controls (n = 64). BMD was assessed using z-score and left hip and lumbar bone density (g/cm2). The results showed that the mean serum vitamin D Levels of all groups was low (<50 nmol/L). Thyroid patients had higher serum vitamin D levels than healthy controls. All groups had normal serum calcium and phosphate levels. The carboxy terminal collagen crosslink and procollagen type I N-terminal propeptide levels were high in hyperthyroid patients and low in hypothyroid patients. The z-score for hip and spine did not significantly differ between thyroid patients and control groups. The hip bone density was remarkably low in the hyperthyroid group. In conclusion, this study showed no correlation between serum 25(OH)D levels and thyroid diseases. The bone markers showed a difference between thyroid groups with no significant difference in BMD.

Fasting experience of patients with Type 2 diabetes mellitus on insulin therapy during Ramadan: VISION Ramadan substudy.

AIMS: To describe the characteristics and fasting experience of a subgroup of patients in the VISION study who initiated insulin therapy and chose to fast during Ramadan, and to discuss the VISION Ramadan substudy data in the context of previous Ramadan studies. METHODS: The VISION study was a prospective, non-interventional, observational study of adult patients with Type 2 diabetes mellitus in 6 countries in the Western Pacific, Middle East and North Africa, receiving insulin injection therapy for the first time. In this VISION Ramadan substudy, fasting data was collected during Ramadan 2014 and 2015. RESULTS: Of 1617 patients in the VISION study, data was collected for 357 patients who chose to fast during Ramadan. At baseline, mean HbA1c was 10.1%, duration of diabetes was 8.8 years, and mean BMI was 30 kg/m2. All patients with non-missing data (n = 169) received advice on fasting during Ramadan. The majority of patients fasted for the full month of Ramadan, and around one-third of patients fasted outside Ramadan. CONCLUSIONS: Here we provide an update on the characteristics and Ramadan experience of patients with Type 2 diabetes mellitus who initiated insulin therapy and chose to fast during Ramadan. There is still a need to explore patient's experience during fasting, and identify and address methods to better help manage those patients.