Pre-conception management.

This communication shares two frameworks which help conceptualize the vast spectrum of pre-conception care. A 3x3 rubric classifies pre-conception assessment and interventions into gynaeco-obstetric, biomedical and psychosocial. Yet another creative checklist uses the letters A through I to present 9 aspects of pre-conception management. The aim of this article is to simplify the vast field of pre-conception care for primary care physicians and other health care professionals.

Screening for Glucose Perturbations and Risk Factor Management in Dysglycemic Patients With Coronary Artery Disease-A Persistent Challenge in Need of Substantial Improvement: A Report From ESC EORP EUROASPIRE V.

OBJECTIVE: Dysglycemia, in this survey defined as impaired glucose tolerance (IGT) or type 2 diabetes, is common in patients with coronary artery disease (CAD) and associated with an unfavorable prognosis. This European survey investigated dysglycemia screening and risk factor management of patients with CAD in relation to standards of European guidelines for cardiovascular subjects. RESEARCH DESIGN AND METHODS: The European Society of Cardiology's European Observational Research Programme (ESC EORP) European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) V (2016-2017) included 8,261 CAD patients, aged 18-80 years, from 27 countries. If the glycemic state was unknown, patients underwent an oral glucose tolerance test (OGTT) and measurement of glycated hemoglobin A1c. Lifestyle, risk factors, and pharmacological management were investigated. RESULTS: A total of 2,452 patients (29.7%) had known diabetes. OGTT was performed in 4,440 patients with unknown glycemic state, of whom 41.1% were dysglycemic. Without the OGTT, 30% of patients with type 2 diabetes and 70% of those with IGT would not have been detected. The presence of dysglycemia almost doubled from that self-reported to the true proportion after screening. Only approximately one-third of all coronary patients had completely normal glucose metabolism. Of patients with known diabetes, 31% had been advised to attend a diabetes clinic, and only 24% attended. Only 58% of dysglycemic patients were prescribed all cardioprotective drugs, and use of sodium-glucose cotransporter 2 inhibitors (3%) or glucagon-like peptide 1 receptor agonists (1%) was small. CONCLUSIONS: Urgent action is required for both screening and management of patients with CAD and dysglycemia, in the expectation of a substantial reduction in risk of further cardiovascular events and in complications of diabetes, as well as longer life expectancy.

Effectiveness of digital health using the transtheoretical model to prevent or delay type 2 diabetes in impaired glucose tolerance patients: protocol for a randomized control trial.

BACKGROUND: There is high prevalence of prediabetes and type 2 diabetes mellitus (T2DM) in Saudi Arabia that is still increasing. Early diagnosis of prediabetes, and immediate, effective intervention is yet unestablished. Conventional health promotion approaches are used to educate prediabetic patients. Behavior modification is very effective in prediabetics to delay T2DM. Thus, the main objective of this study is to examine the effect of the new behavioral model, the Transtheoretical Model short messages (text 4 change) to modify lifestyle to prevent or delay the onset of T2DM, through promotion of a healthy diet and increased physical activity, in impaired glucose tolerance patients. Another objective is to estimate the impact of this model on markers of cardiovascular and metabolic risks as T2DM is one of the modifiable risk factors to prevent cardiovascular diseases. METHODS: This is a randomized controlled trial. One thousand and sixteen, eligible Saudi adults will be recruited from the Heart Health Promotion study (HHP), which was conducted at the King Saud University from July 2013 to April 2014. These adults were at a higher risk of developing T2DM within 2-3 years. The research team's database has a contact list and they will recruit individuals over 6-8 weeks. All participants will be randomized at a 1:1 ratio into two groups, receive group education about lifestyle modifications and written information about diet and physical activity. Text 4 change SMS texts will be sent only to the intervention group. All participants will be assessed at baseline, 6, 12, 18, 24, 30, and 36 months for behavioral change using a World Health Organization (WHO) STEPS questionnaire and for glycated hemoglobin, biochemical and anthropometric measurements using standard methods. DISCUSSION: This new approach for promoting the importance of behavior modification in prediabetics is expected to delay and/or prevent the development of T2DM in Saudi Arabia, subsequently reducing the risk of cardiovascular morbidity and mortality too. Results from this study will promote an innovative and high-tech way to decrease the burden of cardiovascular diseases in Saudi Arabia. TRIAL REGISTRATION: International Standard Randomized Control Trial, registration number ISRCTN10857643. Registered 4 June, 2018.

Testosterone therapy to prevent type 2 diabetes mellitus in at-risk men (T4DM): Design and implementation of a double-blind randomized controlled trial.

BACKGROUND: Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT). AIMS: To determine in a multi-centre, double-blinded placebo-controlled randomized trial whether testosterone treatment combined with lifestyle intervention (Weight Watchers) relative to lifestyle intervention alone reduces T2DM incidence and improves glucose tolerance at 2 years. STUDY POPULATION: Overweight or obese men aged 50-74 years with a serum testosterone of ≤14 nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT). SETTING, DRUG AND PROTOCOL: Six Australian capital city-based tertiary care centres. Participants were randomized 1:1 and injected with testosterone undecanoate (1000 mg/4 mL) or vehicle (4 mL castor oil), at baseline, 6 weeks and 3-monthly thereafter. PRIMARY ENDPOINTS: (a) Proportion of participants with 2-hour OGTT ≥11.1 mmol/L at 2 years, and (b) a difference at 2 years ≥0.6 mmol/L in the mean 2-hour OGTT glucose between treatments. SECONDARY ENDPOINTS: Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs. SAFETY: Overseen by an Independent Data Safety Monitoring Committee. Haematocrit, lipids and prostate-specific antigen (PSA) are assessed 6-monthly and information relating to haematological, urological and cardiovascular adverse events from each clinic visit. SUB-STUDIES: (a) Changes in bone density and micro-architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo-pituitary testicular axis recovery at treatment end.

Cost-Effectiveness of a Short Message Service Intervention to Prevent Type 2 Diabetes from Impaired Glucose Tolerance.

Aims. To investigate the costs and cost-effectiveness of a short message service (SMS) intervention to prevent the onset of type 2 diabetes mellitus (T2DM) in subjects with impaired glucose tolerance (IGT). Methods. A Markov model was developed to simulate the cost and effectiveness outcomes of the SMS intervention and usual clinical practice from the health provider's perspective. The direct programme costs and the two-year SMS intervention costs were evaluated in subjects with IGT. All costs were expressed in 2011 US dollars. The incremental cost-effectiveness ratio was calculated as cost per T2DM onset prevented, cost per life year gained, and cost per quality adjusted life year (QALY) gained. Results. Within the two-year trial period, the net intervention cost of the SMS group was $42.03 per subject. The SMS intervention managed to reduce 5.05% onset of diabetes, resulting in saving $118.39 per subject over two years. In the lifetime model, the SMS intervention dominated the control by gaining an additional 0.071 QALY and saving $1020.35 per person. The SMS intervention remained dominant in all sensitivity analyses. Conclusions. The SMS intervention for IGT subjects had the superiority of lower monetary cost and a considerable improvement in preventing or delaying the T2DM onset. This trial is registered with ClinicalTrials.gov NCT01556880.

Prioritising prevention: implementation of IGT Care Call, a telephone based service for people at risk of developing type 2 diabetes.

AIM: To design, deliver and evaluate IGT Care Call, a telephone service providing a 6 month lifestyle education programme for people with impaired glucose tolerance (IGT). METHODS: An observational study of IGT Care Call, a programme providing motivational support and education using electronic scripts. The service was delivered to 55 participants, all of whom completed the course (an information pack and at least five telephone calls over 6 months). Clinical measurements were undertaken in General Practice at baseline, on completion of the programme and one year later. RESULTS: Among the 40 participants for whom we have complete data available, one year after discharge, participants showed improvements in fasting plasma glucose (0.29 mmol/l, 95% CI 0.07 to 0.51), weight (2.81 kg, 95% CI 1.20 to 4.42) and BMI (1.06 kg/m(2), 95% CI 0.49 to 1.63). All differences were statistically significant (p < 0.01). CONCLUSION: Whilst an uncontrolled observational study with a small sample size, this pilot suggests IGT Care Call may be effective in promoting positive and sustained lifestyle changes to prevent type 2 diabetes, which warrants further investigation. A telephone method of service delivery was acceptable, convenient and may have improved self confidence in how to reduce risk of type 2 diabetes.

Lifestyle intervention in prevention of type 2 diabetes in women with a history of gestational diabetes mellitus: one-year results of the FIN-D2D project.

BACKGROUND: Lifestyle interventions are effective in preventing type 2 diabetes (T2D). Women with history of gestational diabetes mellitus (GDM) may have barriers to lifestyle changes, and the previous results of lifestyle interventions are contradictory reporting either favorable outcomes or no significant beneficial effects. Our aim was to compare cardio-metabolic risk profile and responses to a 1-year lifestyle intervention program in women with and without history of GDM. METHODS: The Implementation Project of the Program for Prevention of Type 2 Diabetes (FIN-D2D) was conducted in Finland in five hospital districts. Altogether 1,661 women aged ≤45 years participated in the program. One-year follow-up was available for 393 women who did not have screen-detected T2D at baseline, and 265 of them had at least one intervention visit [115 (43.4%) women with history of GDM and 150 (56.6%) without history of GDM]. RESULTS: At baseline, women with GDM had similar baseline glucose tolerance but better anthropometric characteristics, blood pressure, and lipid profile than women without GDM after adjustment for age. Beneficial changes in cardiovascular risk profile existed among women with and without GDM during follow-up and the effect of lifestyle intervention was similar between the groups, except that low-density lipoprotein cholesterol improved only in women with GDM. Altogether, 4.0% of those with GDM and 5.0% of those without GDM developed T2D (p=0.959 adjustment for age). CONCLUSIONS: The effect of a 1-year lifestyle intervention in primary healthcare setting was similar regardless of history of GDM, both women with and without GDM benefitted from participation in the lifestyle intervention.

Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial.

AIMS: The cost implications of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial were evaluated using a prespecified analysis plan. METHODS: Purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country. Subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration. RESULTS: The total undiscounted cost per participant in the insulin glargine arm was $13,491 ($13,080 to $14,254) versus $11,189 ($10,568 to $12,147) for standard care, an increase of $2303 ($1370 to $3235; p < 0.0001); the discounted increase was $2099 ($1276 to $2923; P < 0.0001). The greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine. As the trial progressed and the standard group required more anti-diabetic medications, the annual cost difference decreased, reaching $68 (-$160 to $295) in the last year. The subgroup whose baseline diabetes duration was ≥ 6 years achieved cost-savings during the trial. CONCLUSIONS: From a global perspective basal insulin glargine use in ORIGIN incurred greater costs than standard care using older generic drugs. Nevertheless, the cost difference fell with time such that the intervention was cost-neutral by the last year.

A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes.

AIM: To compare the effectiveness and cost of two lifestyle-modification programmes in individuals at high risk of developing type 2 diabetes. METHODS: Forty-eight men and women with a body mass index ≥27 kg/m(2) and prediabetes were randomly assigned to either a 1-year interdisciplinary intervention including individual counseling every 6 weeks and 25 group seminars (group I; n=22) or a group intervention comprising seminars only (group G; n=26). These interventions were compared in terms of weight loss and improvement of anthropometric measures, metabolic variables and costs. RESULTS: Participants in group I lost an average of 4.9 kg (95% CI: -7.3, -2.4; P<0.01) and 5 cm in waist circumference (95% CI: -7.0, -3.0; P<0.01), whereas no significant change was noted in those assigned to group G. Among the participants in group I, 50 and 27% lost at least 5 and 10% of their initial weight, respectively, compared with only 12 and 4%, respectively, in group G. Fasting glucose, 2-hour glucose and lipid profiles improved significantly in group I, and no participant (zero on 22) developed diabetes compared with 11.5% (3/26) in group G. Most participants (nine on 11) with impaired fasting glucose in group I returned to normal. The direct cost of the individual intervention was estimated to be $733.06/year per subject compared with $81.36/year per subject for the group intervention. CONCLUSION: This study demonstrates that a low-cost, moderate-intensity, individual interdisciplinary approach combined with group seminars leads to clinically significant weight loss and metabolic improvement in people with prediabetes. Group seminars alone were not effective in this population (www.ClinicalTrial.gov, Identifier: NCT00991549).

Effect on motivation, perceived competence, and activation after participation in the ''Ready to Act'' programme for people with screen-detected dysglycaemia: a 1-year randomised controlled trial, Addition-DK.

AIM: To investigate the reach of the ''Ready to Act'' programme and the 1-year effects on psychological determinants of healthy behaviour: motivation, perceived competence, and activation level. METHODS: A total of 509 adults with dysglycaemia were recruited from general practioners (GPs) in the intensive arm of the Danish Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION) study, a type 2 diabetes screening programme. The participants were randomised to the ''Ready to Act'' programme added on top of GP care (n = 322) or to GP care (n = 187). The core components of the programme were motivation, action experience, informed decision-making, and social involvement conducted in two one-to-one sessions and eight group-meetings (18 hours). The reach of the programme was measured by the proportion of people who signed up. Outcomes were changes in treatment motivation (Treatment Self-Regulation Questionnaire, TSRQ), perceived competence (Perceived Competence Scale, PCS), and activation in chronic care (Patient Activation Measure, PAM). Effect size was the difference between 1-year changes in the randomisation groups analysed by intention-to-treat. RESULTS: A total of 142 (44%) of 322 signed up and 123 (87%) of these completed. At 1 year, the difference in autonomous motivation for behavioural treatment (TSRQ) between the randomisation groups was 1.0 (95% CI 0.1 to 2.0), and the difference in perceived competence changes in healthy diet (PCS-d) was 1.5 (95% CI 0.2 to 2.7). No differences were observed for activation (PAM) between the groups. Subgroup analysis revealed men to benefit more from the intervention than women. CONCLUSIONS: The programme is a promising health-promoting component in prevention and care for people with screen-detected dysglycaemia, as it attracted four of 10 people and had effects on motivation and perceived competence.

The effect of increased ambulatory activity on markers of chronic low-grade inflammation: evidence from the PREPARE programme randomized controlled trial.

AIMS: To investigate whether an exercise intervention programme, with or without pedometer use, is effective at reducing chronic low-grade inflammation in those with impaired glucose tolerance. METHODS: Using baseline and 12-month data from the Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme randomized controlled trial, we investigated whether the pedometer or the standard version of the PREPARE programme is associated with reduced chronic low-grade inflammation. Outcomes included interleukin-6, C-reactive protein, fasting and 2 h post-challenge glucose values and objectively measured ambulatory activity. RESULTS: Seventy-four participants (31% female; mean age, 65 years; body mass index, 29.3 ± 4.8 kg/m(2) ) were included, of which 26 were in the control group and 24 were in each intervention group. At 12 months there was an increase in ambulatory activity of 1351 and 1849 steps/day in the standard and pedometer group, respectively, compared with control conditions; however, there was no significant change in markers of chronic low-grade inflammation. Across the pooled study sample, change in ambulatory activity was significantly correlated with change in interleukin-6 (r = -0.32, P = 0.01) after adjustment for group, age, sex, ethnicity, aspirin and statin medication, baseline body mass index and change in body mass index. Change in interleukin-6 was also significantly correlated with change in 2 h glucose after adjustment for the same variables (r = 0.26, P = 0.03). CONCLUSIONS: This study failed to show reductions in markers of chronic low-grade inflammation following an intervention that promoted modest increases in ambulatory activity; however, across the study sample, increased ambulatory activity was associated with reduced interleukin-6, independent of obesity.

An update on the Diabetes Prevention Program.

OBJECTIVE: To summarize the results of the Diabetes Prevention Program (DPP) and describe the additional 5-year follow-up study. METHODS: The design, implementation, and outcome of the DPP are reviewed, and an economic analysis of the effects of diabetes prevention and delay is presented. RESULTS: The DPP, thus far the largest diabetes prevention trial with the most ethnically diverse patient population, originally consisted of more than 3,800 subjects with impaired glucose tolerance. These subjects were randomized to receive one of four interventions: intensive lifestyle adjustments or standard lifestyle plus one of the following--placebo, metformin, or troglitazone. In June 1998, the troglitazone treatment was discontinued after a fatal case of liver failure in a study participant, but the subjects in this arm of the study continued to undergo followup. Thus, 3,234 subjects remained in the other three arms of the study. After a mean of 2.8 years of follow-up, the DPP was prematurely terminated because of an observed significant benefit to the intervention groups. Both metformin therapy and intensive lifestyle intervention reduced the risk of developing diabetes (by 31% and 58%, respectively, in comparison with placebo), and both interventions were deemed to be cost-effective on the basis of computer projections over a lifetime. Because of the premature discontinuation of the DPP, the durability of the interventions on diabetes prevention and the effect on microvascular and macrovascular disease could not be assessed. The subsequent outcomes study will address these issues during a 5-year follow-up period. CONCLUSION: The DPP showed that both metformin and intensive lifestyle modifications effectively delayed or prevented the development of diabetes in a cost-effective manner.

Comparison of insulin sensitivity assessment indices with euglycemic-hyperinsulinemic clamp data after a dietary and exercise intervention in older adults.

Multiple indices to assess insulin sensitivity calculated from mathematical equations based on fasting blood parameters or oral glucose tolerance data have been developed. Although these indices have frequently been validated using euglycemic-hyperinsulinemic clamp data, the utility of each equation in measuring change in insulin sensitivity over time remains uncertain. We examined change in insulin sensitivity in response to a 12-week diet and exercise intervention in 31 older men and women with impaired glucose tolerance using a euglycemic-hyperinsulinemic clamp and 10 commonly used insulin sensitivity equations. Mean glucose disposal as calculated from clamp data was significantly higher after the intervention compared with baseline (5.92 +/- 0.38 vs 5.18 +/- 0.30 mg . kg fat free mass(-1) . min(-1), P = .013). In contrast, none of the examined indices indicated a significant change in insulin sensitivity over time (all P > .3). A limits of agreement approach to compare insulin sensitivity calculated from each equation with the measure of glucose disposal from the clamp indicated overall imperfect agreement between measures (agreement limits ranged from +/-2.48 to +/-4.23 mg . kg fat free mass(-1) . min(-1)) despite significant bivariate correlations between indices and clamp data. The wide variability in the 95% prediction limits of agreement among equations suggests that these equations vary substantially from a euglycemic-hyperinsulinemic clamp in their ability to assess insulin sensitivity. Despite the observed limited agreement using this statistical approach, changes in several calculated indices were significantly correlated with changes in clamp data, suggesting that these indices may have some utility in tracking improvements in insulin sensitivity. Further research is necessary to examine agreement between indices and clamp data in larger, more heterogeneous populations and in response to other interventions where the magnitude of change in insulin sensitivity may be larger.

Economic evaluation of therapeutic interventions to prevent Type 2 diabetes in Canada.

AIMS: To compare the health and economic outcomes of using acarbose, an intensive lifestyle modification programme, metformin or no intervention to prevent progression to diabetes in Canadian individuals with impaired glucose tolerance (IGT). METHODS: A model was developed to simulate the course of individuals with IGT under each treatment strategy. Patients remain in the IGT state or transition from IGT to diabetes, to normal glucose tolerance (NGT) or to death. Effectiveness and resource use data were derived from published intervention trials. A comprehensive health-care payer perspective incorporating all major direct costs, reported in 2000 Canadian dollars, was adopted. RESULTS: Over a decade, 70 of the 1000 untreated patients are expected to die and 542 develop diabetes. Intensive lifestyle modification is estimated to prevent 117 cases of diabetes, while metformin would prevent 52 and acarbose 74 cases. The proportion of those who return to NGT also increases with any treatment. While lifestyle modification is more effective, it can increase overall costs depending on how it is implemented, whereas acarbose and metformin reduce costs by nearly $1000 per patient. Lifestyle modification was cost effective, varying from CAD $10 000/LYG vs. acarbose. Acarbose costs somewhat more than metformin, but is more effective: CAD $1798/LYG. CONCLUSION: The results of this model suggest that the treatment of IGT in Canada is a cost-effective way to prevent diabetes and may generate savings. While pharmacological treatments tended to be less costly, intensive lifestyle modification, if maintained, led to the greatest health benefits at reasonable incremental costs.