Diabetes text-message self-management support program (SMS4BG): a pilot study

BACKGROUND: The increasing prevalence of diabetes and costly long-term complications associated with poor glycemic control are issues facing health services worldwide. Diabetes self-management, with the support of health care providers, is critical for successful outcomes, however, frequent clinical contact is costly. Text messages via short message service (SMS) have the advantage of instant transmission at low cost and, given the ubiquity of mobile phones, may be the ideal platform for the delivery of diabetes self-management support. A tailored text message-based diabetes support intervention called Self-Management Support for Blood Glucose (SMS4BG) was developed. The intervention incorporates prompts around diabetes education, management, and lifestyle factors (healthy eating, exercise, and stress management), as well as blood glucose monitoring reminders, and is tailored to patient preferences and clinical characteristics. OBJECTIVE: To determine the usability and acceptability of SMS4BG among adults with poorly controlled diabetes. METHODS: Adults (aged 17 to 69 years) with type 1 (n=12) or type 2 diabetes (n=30), a hemoglobin A1c (HbA1c) over 70 mmol/mol (8.6%), and who owned a mobile phone (n=42) were recruited to take part in a 3-month pilot study of SMS4BG. At registration, participants selected the modules they would like to receive and, where appropriate, the frequency and timing of blood glucose monitoring reminders. Patient satisfaction and perceptions of the usability of the program were obtained via semistructured phone interviews conducted at completion of the pilot study. HbA1c was obtained from patient records at baseline and completion of the pilot study. RESULTS: Participants received on average 109 messages during the 3-month program with 2 participants withdrawing early from the study. Follow-up interviews were completed with 93% of participants with all reporting SMS4BG to be useful and appropriate to their age and culture. Participants reported a range of perceived positive impacts of SMS4BG on their diabetes and health behaviors. HbA1c results indicated a positive impact of the program on glycemic control with a significant decrease in HbA1c from baseline to follow-up. CONCLUSIONS: A tailored text message-based intervention is both acceptable and useful in supporting self-management in people with poorly controlled diabetes. A randomized controlled trial of longer duration is needed to assess the efficacy and sustainability of SMS4BG

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial

BACKGROUND: Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. METHODS/DESIGN: A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. DISCUSSION: This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment.<br /

Use of 50/50 premixed insulin analogs in Type 2 Diabetes: systematic review and clinical recommendations

IntroductionPremixed insulin analogs represent an alternative to basal or basal&ndash;bolus insulin regimens for the treatment of type 2 diabetes (T2D). &ldquo;Low-mix&rdquo; formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal&ndash;bolus therapy, for insulin initiation and intensification.MethodsMEDLINE, EMBASE, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, LillyTrials.com, and NovoNordisk-trials.com were searched (11 or 13 Dec 2016) using terms for T2D, premixed insulin analogs, and/or Mix50. Studies (randomized, nonrandomized, or observational; English only) comparing Mix50 with other insulins (except human) and reporting key efficacy [glycated hemoglobin (HbA1c), fasting and postprandial glucose] and/or safety (hypoglycemia, weight gain) outcomes were eligible for inclusion. Narrative reviews, letters, editorials, and conference abstracts were excluded. Risk of bias in randomized trials was assessed using the Cochrane tool.ResultsMEDLINE and EMBASE searches identified 716 unique studies, of which 32 met inclusion criteria. An additional three studies were identified in the other databases. All 19 randomized trials except one were open label; risk of other biases was generally low. Although not conclusive, the evidence suggests that Mix50 may provide better glycemic control (HbA1c reduction) and, particularly, postprandial glucose reduction in certain patients, such as those with high carbohydrate diets and Asian patients, than low-mix and basal therapy. Based on this evidence and our experience, we provide clinical guidance on factors to consider when deciding whether Mix50 is appropriate for individual patients.ConclusionsMix50 may be more suitable than low-mix therapy for certain patients. Clinicians should consider not only efficacy and safety but also patient characteristics and preferences when tailoring insulin treatment to individuals with T2D

Effect of onset of type 2 diabetes on risks of cardiovascular disease and heart failure among new Zealanders with impaired glucose tolerance over 25 years: tapered-matched landmark analysis

BackgroundThis study aimed to examine the association between the incident onset of T2DM and 5- and 10-year risks of CVD and HF in people with IGT identified in primary care in South and West Auckland, New Zealand (NZ) between 1994 and 2019.MethodsWe compared CVD and HF risks in patients with IGT and with/without T2D newly diagnosed within the exposure window (1–5 years). Tapered matching and landmark analysis (to account for immortal bias) were used to control for potential effects of known confounders.ResultsAmong 26,794 patients enrolled with IGT, 845 had T2D newly diagnosed within 5 years from enrolment (landmark date) and 15,452 did not have T2D diagnosed. Patients progressing to T2D (vs. those not progressing) had a similar 5-year risk for CVD (hazard ratio 1.19; 95% CI 0.61–2.32) but significantly higher 10-year risk of CVD (2.45(1.40–4.29)), 5-year risk of HF (1.94(1.20–3.12)) and 10-year risk of HF (2.84(1.83–4.39). The association between the onset of T2D and risk of 10-year risk of CVD, 5-year and 10-year risk of HF was more likely among men, the socioeconomically deprived, those currently smoking, patients with higher metabolic measures and/or those with lower renal function. Patients of NZ European ethnicity had a lower 10-year risk of CVD.ConclusionsThe study suggests that the diagnosis of T2D mediates the risk of CVD and HF in people with IGT. The development of risk scores to identify and better manage individuals with IGT at high risk of T2D is warranted

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Ethnic differences in mortality and hospital admission rates between Māori, Pacific, and European New Zealanders with type 2 diabetes between 1994 and 2018 : a retrospective, population-based, longitudinal cohort study

Background Type 2 diabetes affects Indigenous and non-European populations disproportionately, including in New Zealand, where long-term temporal trends in cause-specific clinical outcomes between Māori, Pacific, and European people remain unclear. We aimed to compare the rates of mortality and hospital admission between Māori, Pacific, and European patients with type 2 diabetes in Auckland, New Zealand, over a period of 24 years. Methods In this retrospective, population-based, longitudinal cohort study, we identified a cohort of patients (aged 35–84 years) with type 2 diabetes enrolled between Jan 1, 1994, and July 31, 2018, to the primary care audit programme, the Diabetes Care Support Service (DCSS) in Auckland, New Zealand. Patients with type 1 diabetes, prediabetes, and gestational diabetes were excluded. We linked data from the DCSS with national death registration, hospital admission, pharmaceutical claim, and socioeconomic status databases. Patients were followed up until death or July 31, 2018 (date of last enrolment to the DCSS). Incident clinical events (all-cause mortality, cardiovascular mortality, cancer mortality, cardiovascular hospital admission, cancer hospital admission, and end-stage renal disease hospital admission) were identified. Event rates were stratified by ethnic group, age group, sex, socioeconomic status, and time period (<1998, 1999–2013, 2004–08, 2009–13, and 2014–18). Incidence rate ratios (IRRs) and absolute risk differences were adjusted for sex, age, smoking status, obesity, socioeconomic status, and time period by use of age-period-cohort modelling. Findings Between Jan 1, 1994, and July 31, 2018, 45 072 patients with type 2 diabetes (21 936 [48·7%] female; mean age 56·7 years [SD 13·8]) were enrolled in the DCSS and followed up for a median of 9·7 years (IQR 5·8–13·6). 16 755 (37·2%) were European, 7093 (15·7%) were Māori, and 12 044 (26·7%) were Pacific patients. Despite a similar temporal trend (decreasing mortality and increasing hospital admissions) across the three ethnic groups, Māori and Pacific patients had consistently higher hospital admission rates than European patients. Māori but not Pacific patients had higher adjusted IRRs for all-cause mortality (1·96 [95% CI 1·80–2·14]), cardiovascular mortality (1·93 [1·63–2·29]) and cancer mortality (1·64 [1·40–1·93]) rates compared with European patients. Interpretation Compared with European patients, poorer health outcomes have persisted among Māori and Pacific people with type 2 diabetes for more than 20 years. New policies supporting prevention and more intensive management of type 2 diabetes are urgently needed. Research into the biological and societal mechanisms underlying these disparities, and the associated differences between Māori and Pacific patients is also needed

Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations

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All-cause, premature, and cardiovascular death attributable to socioeconomic and ethnic disparities among New Zealanders with type 1 diabetes 1994–2019: a multi-linked population-based cohort study

Background: New Zealand (NZ) research into type 1 diabetes mellitus (T1DM) mortality can inform policy and future research. In this study we aimed to quantify the magnitude to which ethnicity and socioeconomic disparities influenced mortality at the population level among people with Type 1 diabetes (T1DM) in Auckland, New Zealand (NZ). Methods: The cohort data were derived from the primary care diabetes audit program the Diabetes Care Support Service (DCSS), and linked with national primary care, pharmaceutical claims, hospitalisation, and death registration databases. People with T1DM enrolled in DCSS between 1994–2018 were included. All-cause, premature, and cardiovascular mortalities were estimated by Poisson regression models with adjustment for population-level confounders. The mortality rates ratio (MRR) was standardized against the DCSS type 2 diabetes population. Mortality rates were compared by ethnic group (NZ European (NZE) and non-NZE) and socioeconomic deprivation quintile. The population attributable fraction (PAF) was estimated for ethnic and socioeconomic disparities by Cox regression adjusting for demographic, lifestyle, and clinical covariates. The adjusted slope index inequality (SII) and relative index of inequality (RII) were used to measure the socioeconomic disparity in mortalities. Results: Overall, 2395 people with T1DM (median age 34.6 years; 45% female; 69% NZE) were enrolled, among whom the all-cause, premature and CVD mortalities were 6.69 (95% confidence interval: 5.93–7.53), 3.30 (2.77–3.90) and 1.77 (1.39–2.23) per 1,000 person-years over 25 years. The overall MRR was 0.39 (0.34–0.45), 0.65 (0.52–0.80), and 0.31 (0.24–0.41) for all-cause, premature and CVD mortality, respectively. PAF attributable to ethnicity disparity was not significantly different for mortality. The adjusted PAF indicated that 25.74 (0.84–44.39)% of all-cause mortality, 25.88 (0.69–44.69)% of premature mortality, 55.89 (1.20–80.31)% of CVD mortality could be attributed to socioeconomic inequality. The SII was 8.04 (6.30–9.78), 4.81 (3.60–6.02), 2.70 (1.82–3.59) per 1,000 person-years and RII was 2.20 (1.94–2.46), 2.46 (2.09–2.82), and 2.53 (2.03–3.03) for all-cause, premature and CVD mortality, respectively. Conclusions: Our results suggest that socioeconomic disparities were responsible for a substantial proportion of all-cause, premature and CVD mortality in people with T1DM in Auckland, NZ. Reducing socioeconomic barriers to management and self-management would likely improve clinical outcomes