Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study.

AIM: To evaluate the clinical and health behavioural outcomes of a large sample of participants from the Diabetes Conversation Map™ Program. DESIGN: A matched-case-control study that was performed on a retrospective cohort study. METHODS: Participants were 11,053 Clalit Health Services members with type 2 diabetes who enrolled in the Diabetes Conversation Map™ Program between January 2010 - April 2016. The matched-control group was formulated using sequential matching, by matching cases to controls at a ratio of 1:3, based on age, sex, and HbA1c level. The associations between the programme group and annual clinical and health behaviours were assessed between cases and controls at five time points using linear and Poisson regression analyses. RESULTS: The intervention group had significantly lower HbA1c, glucose, and low-density lipoprotein levels and more frequent glucose blood testing each year up to 36 month post-enrolment compared with the matched controls. Other outcomes were significantly different for shorter time periods, including higher high-density lipoprotein and lower triglyceride levels at 6- and 12-month follow-up and lower diastolic blood pressure and greater medication adherence at 6-month follow-up. CONCLUSIONS: Enrolment in the programme was associated with improved clinical and health behaviour outcomes for at least 6 months and most outcomes persisted for up to 36 months. IMPACT: This is the first study to evaluate the Diabetes Conversation Map™ Program with a large sample over long period of time. This nurse-led group intervention evaluation adds to the literature on health outcomes on the lives of patients with type 2 diabetes. STUDY REGISTRATION: This study was registered retrospectively to the Open Science Framework, the registration form can be found at: https://osf.io/63cse.

Temporal changes in the incidence and predictors of severe hypoglycaemia in type 2 diabetes: The Fremantle Diabetes Study.

AIM: To determine the incidence of severe hypoglycaemia and its predictors in community-based patients with type 2 diabetes studied between 2008 and 2013 compared with those in a cohort of patients with type 2 diabetes from the same geographical area assessed a decade earlier. METHODS: We studied 1551 participants (mean age 65.7 years, 51.9% men) with type 2 diabetes from the longitudinal observational Fremantle Diabetes Study Phase II (FDS2). Severe hypoglycaemia was ascertained as that requiring ambulance attendance, emergency department services and/or hospitalization. Cox proportional hazards modelling was used to determine predictors of a first episode of severe hypoglycaemia, and negative binomial regression was used to identify predictors of frequency. RESULTS: Sixty-three participants (4.1%) experienced 83 episodes, representing an incidence of 1.34/100 participant-years (95% confidence interval [CI] 1.08 to 1.67; vs 1.67/100 participant-years [95% CI 1.31-2.13] in the Fremantle Diabetes Study Phase I [FDS1]; P = 0.18). Those experiencing severe hypoglycaemia experienced one to four episodes in both cohorts. The independent predictors of incident severe hypoglycaemia in the FDS2 were: older age; higher educational attainment; alcohol consumption; current smoking; sulphonylurea/insulin treatment; prior severe hypoglycaemia; renal impairment; and plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP). The same variables except smoking were associated with frequency of severe hypoglycaemia. Most of these risk factors paralleled those in the FDS1, but current smoking and plasma NT-proBNP were novel. CONCLUSIONS: The incidence and frequency of severe hypoglycaemia did not change between the Fremantle Diabetes Study phases but novel risk factors, including plasma NT-proBNP, were observed in the FDS2.

A multinational observational study assessing insulin use: Understanding the determinants associated with progression of therapy.

AIMS: To describe global patterns of insulin treatment and to assess the impact of patient, provider, health system and economic influences on treatment decisions for patients with insulin-treated type 2 diabetes (T2D). METHODS: This prospective cohort study of insulin-treated patients with T2D was conducted across 18 countries categorized as high, upper-middle or lower-middle income regions. Information collected from patients included knowledge of diabetes, experiences and interactions with their healthcare provider. Physician information included specialty, practice size, availability of diabetes support services, volume of diabetes patients treated and time spent per patient. Physicians determined an individualized haemoglobin A1c (HbA1c) target for each patient by the start of the study. Changes in T2D therapies and HbA1c were recorded for 2 years. RESULTS: Complete treatment data were available for 2528 patients. Median age was 61 years and median duration of diabetes was 11.4 years. Changes to treatment regimen occurred in 90.0% of patients, but changes were less common in countries with a higher economic status (P < 0.001). Most treatment changes involved insulin, with changes in dose the most common. Overall predictors of change in insulin therapy included younger age, use of any insulin regimen other than basal only, higher mean baseline HbA1c and longer duration of T2D. HbA1c levels remained constant regardless of regional economic status. At baseline, 20.6% of patients were at their HbA1c target; at 2 years this was 26.8%. CONCLUSIONS: Among insulin-treated patients with T2D, treatment changes were common; however, only approximately one-fourth of individuals achieved their HbA1c target.

Temporal changes in glycaemic thresholds for treatment intensification in type 2 diabetes in an urban Australian setting: the Fremantle Diabetes Study.

BACKGROUND: Pharmacotherapy and supportive care for diabetes in Australia are improving, with potential beneficial effects on therapeutic procrastination. AIM: To determine whether glycaemic thresholds for therapeutic intensification in type 2 diabetes changed over the 15 years between phases of the community-based Fremantle Diabetes Study (FDS). METHODS: We studied 531 Phase 1 participants (mean age 62.4 years, 54.2% males, median diabetes duration 3.0 years) with valid data from baseline assessment and five subsequent annual reviews between 1993 and 2001 and 930 Phase 2 participants (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline and two subsequent biennial reviews between 2008 and 2015. The main outcome measure was HbA1c at assessments before and after change in blood glucose-lowering therapy (average 6 months in Phase 1, 12 months in Phase 2). RESULTS: Ninety-seven participants in Phase 1 and 84 in Phase 2 progressed from diet-based management to oral hypoglycaemic agents (OHA) and 45 and 85 participants, respectively, progressed from diet/OHA to insulin. The median HbA1c was 7.5% (58 mmol/mol) and 6.9% (52 mmol/mol) before OHA initiation in Phases 1 and 2, respectively, and 9.1% (76 mmol/mol) and 7.8% (62 mmol/mol), respectively, before insulin initiation. There were median HbA1c falls of 0.3% (3 mmol/mol) and 1.5% (16 mmol/mol) after OHA and insulin initiation in Phase 1, but no statistically significant changes in Phase 2. CONCLUSIONS: HbA1c thresholds triggering treatment intensification fell between FDS phases, suggesting a more proactive approach to management of glycaemia over time.

THE CARIES MANAGEMENT SYSTEM: UPDATING COST-EFFECTIVENESS WITH 4-YEAR POSTTRIAL DATA.

OBJECTIVES: Long-term follow-up of the Caries Management System (CMS) protocol demonstrated that regular monitoring and noninvasive management of dental caries is effective in reducing the number of caries-related events over a 7-year period. This analysis complements the authors' original economic evaluation of the CMS by re-evaluating the per-protocol cost-effectiveness of the CMS approach. METHODS: An individual patient-simulation Markov model was developed previously, based on 3-year randomized-controlled trial (RCT) data, to simulate the incidence and progression of dental caries, and resultant interventions, and to evaluate the lifetime cost-effectiveness of the CMS versus standard dental care from the Australian private dental practitioner perspective (in which the baseline age distribution was similar to that of the Australian population). The 4-year posttrial follow-up data are used to re-evaluate the long-term cost-effectiveness of the CMS in a more real-life setting. RESULTS: The reduction in caries risk was maintained among those practices within which the CMS protocols were adhered to. The per-protocol model appears to be reasonably accurate at predicting the risk of restorative events in the posttrial follow-up period. The per-protocol lifetime cost per restorative event avoided is AUD1,980 (USD1,409; 1 AUD = 0.71 USD). CONCLUSIONS: The current analysis confirms that the CMS approach is both effective, when the protocols are adhered to appropriately, and cost-effective compared with standard care in the Australian private practice setting.

A qualitative examination of the content validity of the EQ-5D-5L in patients with type 2 diabetes.

BACKGROUND: The EQ-5D is frequently used to derive utilities for patients with type 2 diabetes (T2D). Despite widely available quantitative psychometric data on the EQ-5D, little is known about content validity in this population. Thus, the purpose of this qualitative study was to examine content validity of the EQ-5D in patients with T2D. METHODS: Patients with T2D in the UK completed concept elicitation interviews, followed by administration of the EQ-5D-5L and cognitive interviewing focused on the instrument's relevance, clarity, and comprehensiveness. RESULTS: A total of 25 participants completed interviews (52.0 % male; mean age = 53.5 years). Approximately half (52 %) reported that the EQ-5D-5L was relevant to their experience with T2D. When asked if each individual item was relevant to their experience with T2D, responses varied widely (24.0 % said the self-care item was relevant; 68.0 % said the anxiety/depression item was relevant). Participants frequently said items were not relevant to themselves, but could be relevant to patients with more severe diabetes. Most participants (92.0 %) reported that T2D and/or its treatment/monitoring requirements had an impact on their quality of life that was not captured by the EQ-5D-5L. Common missing concepts included food awareness/restriction (n = 13, 52.0 %); activities (n = 11, 44.0 %); emotional functioning other than depression/anxiety (n = 8, 32.0 %); and social/relationship functioning (n = 8, 32.0 %). CONCLUSIONS: The results highlight strengths and potential limitations of the EQ-5D-5L, including missing content that could be important for some patients with T2D. Suggestions for addressing limitations are provided.

Geographic patterns in patient demographics and insulin use in 18 countries, a global perspective from the multinational observational study assessing insulin use: understanding the challenges associated with progression of therapy (MOSAIc).

BACKGROUND: Among patients with type 2 diabetes, insulin intensification to achieve glycemic targets occurs less often than clinically indicated. Barriers to intensification are not well understood. We present patients' baseline characteristics from MOSAIc, a study investigating patient-, physician-, and healthcare environment-based factors affecting insulin intensification and subsequent health outcomes. METHODS: MOSAIc is a longitudinal, observational study following patients' diabetes care in 18 countries: United Arab Emirates (UAE), Argentina, Brazil, Canada, China, Germany, India, Israel, Italy, Japan, Mexico, Russia, Saudi Arabia, South Korea, Spain, Turkey, United Kingdom, United States. Eligible patients are age ≥ 18, have type 2 diabetes, and have used insulin for ≥ 3 months with/without other antidiabetic medications. Extensive baseline demographic, clinical, and psychosocial data are collected at baseline and regular intervals during the 24-month follow-up. We conducted descriptive analyses of baseline data. RESULTS: Four thousand three hundred forty one patients met eligibility criteria. Patients received their type 2 diabetes diagnosis 12 ± 8 years prior to baseline visit, yet patients in developing countries were younger than in developed countries (e.g., UAE, 55 ± 10; Germany = 70 ± 10). Saudi Arabians had the highest HbA1c values (9.0 ± 2.2) and Germany (7.5 ± 1.4) among the lowest. Most patients in 5 (28%) of the 18 countries did not use an oral antidiabetic drug. Over half of patients in fourteen (78 %) countries exclusively used basal insulin; most Indian and Chinese patients exclusively used mixed insulin. CONCLUSIONS: MOSAIc's baseline data highlight differences in patient characteristics across countries. These patterns, along with physician and healthcare environment differences, may contribute to the likelihood of insulin intensification and subsequent clinical outcomes.

Efficacy and safety of insulin lispro in obese patients with type 2 diabetes: a retrospective metaanalysis of 7 randomized controlled trials.

OBJECTIVE: To evaluate the efficacy and safety of insulin lispro in the treatment of patients with type 2 diabetes (T2DM) who had a body mass index (BMI) ≥30 kg/m2 (obese) compared with patients with BMIs <30 kg/m2 (nonobese). METHODS: A retrospective analysis of predefined end-points from 7 randomized clinical trials of T2DM patients treated with insulin lispro was performed. The primary efficacy measure was to assess the noninferiority of insulin lispro in obese patients versus nonobese patients as measured by the change in hemoglobin A1C (HbA1c) from baseline to Month 3 (n = 1,518), using a noninferiority margin of 0.4%. The secondary measures included overall hypoglycemia incidence and event rates and relative change in body weight. RESULTS: Mean changes in HbA1c from baseline (9.06% for obese and 8.92% for nonobese) to Month 3 were similar for obese patients (-1.03%) and nonobese (-1.02%), with a least squares (LS) mean difference (95% confidence interval [CI]) of -0.05% (-0.17%, 0.07%; P = .384). The overall incidence of hypoglycemia (53% vs. 63%; P<.001) and rate of hypoglycemia (0.93 vs. 1.76 events per 30 days; P<.001) was significantly lower in obese patients compared with nonobese patients. The 2 BMI cohorts did not demonstrate a significant difference in mean percent changes in body weights (LS mean difference = 0.4% [-0.2%, 0.9%]; P = .202). CONCLUSION: Obese patients with T2DM treated with insulin lispro were able to achieve the same level of glycemic control as their nonobese counterparts, with some evidence supporting a reduced risk of hypoglycemia.

Healthcare costs and adherence associated with human regular U-500 versus high-dose U-100 insulin in patients with diabetes.

OBJECTIVE: Describe the characteristics, costs, and adherence of patients receiving human regular U-500 insulin (U-500R) compared with those of patients receiving high-dose (≥150 units/day) U-100 insulin. METHODS: Data from Truven Health MarketScan Research Databases, July 1, 2008, through December 31, 2010, were used. The U-100 cohort received ≥150 units/day of U-100 insulin for ≥31 days during the first 60 days after the index date. The U-500R cohort received ≥2 prescriptions of U-500R after the index date. Analyses were performed on propensity-matched cohorts. The changes in annualized costs were compared between the 2 cohorts using paired t tests. Adherence was assessed by the proportion of days covered (PDC) and compared using a 2-sample t test. Glycemic efficacy data were not available in this database. RESULTS: There were 1,044 U-500R-treated patients (19.1% with type 1 diabetes [T1D]) and 11,520 U-100-treated patients (23.8% with T1D) identified, from which 1,039 matched pairs were obtained. The mean decrease of $1,290 in annual pharmacy costs for the U-500R cohort was significantly different from the mean increase of $2,586 for the U-100 cohort (P<.001; 95% confidence interval, -$4,345 to -$3,422). More U-500R patients experienced hypoglycemia (17.3% vs. 11.8%; P<.001), but the hypoglycemia rate per person and related costs were not significantly different between cohorts. Finally, the mean 12-month PDC was 65.0% for U-500R versus 47.6% for U-100 patients (P<.0001). CONCLUSION: Compared with treatment with ≥150 units/day of U-100 insulin, treatment with U-500R was associated with decreases in pharmacy costs, a higher percentage of patients experiencing hypoglycemia, and greater treatment adherence.

Efficacy and safety of insulin lispro in geriatric patients with type 2 diabetes: a retrospective analysis of seven randomized controlled clinical trials.

BACKGROUND AND AIMS: Glycemic control in geriatric patients with type 2 diabetes (T2DM) remains clinically challenging. The objective of this study was to compare the safety and efficacy of insulin lispro in patients C65 years (geriatric) to those\65 years (non-geriatric), using a metaanalysis of randomized controlled clinical trials (RCT). METHODS: This is a retrospective analysis of predefined endpoints from an integrated database of seven RCTs of T2DM patients treated with insulin lispro. The primary efficacy measure tested the non-inferiority of insulin lispro (geriatric vs. non-geriatric; non-inferiority margin 0.4 %) in terms of hemoglobin A1c (HbA1c) change from baseline to Month 3 (N = 1,525), with change from baseline to Month 6 as a supportive analysis (N = 885). Changes in HbA1c from baseline were evaluated with an analysis of covariance model. Secondary measures included incidence and rate of hypoglycemia, and incidence of cardiovascular events. RESULTS: Mean change in HbA1c from baseline to Month 3 was similar for geriatric (-0.97 %) and non-geriatric patients (-1.05 %); least-square (LS) mean difference (95 % CI) was 0.02 % (-0.11, 0.15 %; p = 0.756). Similar results were observed in patients treated up to Month 6; LS mean difference (95 % CI) was 0.07 % (-0.12, 0.26 %; p = 0.490). Decrease in HbA1c from baseline to Months 3 and 6 was non-inferior in geriatric compared with non-geriatric patients. There were no significant differences in the incidence and the rate of hypoglycemia, incidence of cardiovascular events, or other serious adverse events including malignancy, post-baseline between the two cohorts. CONCLUSION: Key measures of efficacy and safety in geriatric patients with T2DM were not significantly different from non-geriatric patients when utilizing insulin lispro. Insulin lispro may be considered a safe and efficacious therapeutic option for the management of T2DM in geriatric patients.

Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c.

BACKGROUND: One possible barrier to effective diabetes self-management is hypoglycaemia associated with diabetes medication. The current study was conducted to characterize hypoglycaemic events among UK patients with type 2 diabetes (T2D) treated with antihyperglycaemic medications, and assess the relationship between experience of hypoglycaemic events and health outcomes, including glycaemic control, health-related quality of life, impairment to work and non-work activities, treatment satisfaction, adherence to treatment, fear of hypoglycaemia, and healthcare resource use. METHODS: An online survey of 1,329 T2D patients in UK drawn from an opt-in survey panel was conducted in February of 2012 with monthly follow-up questionnaires for five months. Measures included self-reported HbA1c, EQ-5D, Work Productivity and Activity Impairment questionnaire, Diabetes Medication Satisfaction Tool, Morisky medication adherence scale, the Hypoglycaemia Fear Survey (revised), and self-reported healthcare resource use. Comparisons were conducted using t-tests and chi-square tests for continuous and categorical variables, respectively. RESULTS: Baseline comparisons showed that worse HbA1c, greater diabetes-related healthcare resource use, greater fear of hypoglycaemia, and impaired health outcomes were associated with experience of hypoglycaemia in the four weeks prior to baseline. Longitudinal results were similar in direction but differences on few measures were significant. CONCLUSIONS: In real-world UK T2D patients, hypoglycaemia is associated with worse self-reported glycaemic control, behaviours that contribute to worse glycaemic control, and impairment in patient-reported outcomes.

Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8-45.

OBJECTIVES: The content validity of the 28-item PedsQL™ 3.0 Diabetes Module has not been established in research on pediatric and adult patients with newly diagnosed Type 1 diabetes across a broad age range. This study aimed to document the content validity of three age-specific versions (8-12 years, 13-18 years, and 18-45 years) of the PedsQL™ Diabetes Module in a population of newly diagnosed patients with Type 1 diabetes. METHODS: The study included in-depth interviews with 31 newly diagnosed patients with Type 1 diabetes between the ages of 8 and 45 years, as well as 14 parents and/or caregivers of child and teenage patients between the ages of 8 and 18 years of age; grounded theory data collection and analysis methods; and review by clinical and measurement experts. RESULTS: Following the initial round of interviews, revisions reflecting patient feedback were made to the Child and Teen versions of the Diabetes Module, and an Adult version of the Diabetes Module was drafted. Cognitive interviews of the modified versions of the Diabetes Module were conducted with an additional sample of 11 patients. The results of these interviews support the content validity of the modified 33-item PedsQL™ 3.2 Diabetes Module for pediatric and adult patients, including interpretability, comprehensiveness, and relevance suitable for all patients with Type 1 Diabetes. CONCLUSIONS: Qualitative methods support the content validity of the modified PedsQL™ 3.2 Diabetes Module in pediatric and adult patients. It is recommended that the PedsQL™ 3.2 Diabetes Module replaces version 3.0 and is suitable for measuring patient-reported outcomes in all patients with newly diagnosed, stable, or long-standing diabetes in clinical research and practice.

Clinical and radiographic evaluation of NobelActive(TM) dental implants.

OBJECTIVES: To conduct a randomised controlled trial to evaluate the short-term clinical and radiographic efficacy of the NobelActive™ system and to evaluate the relative importance of achieving primary stability at placement. MATERIALS AND METHODS: A total of 32 subjects were recruited and, using a split-mouth design, the NobelActive(TM) implant was compared with a contralaterally matched Brånemark implant. Both implants were placed in a single surgical procedure into healed sites using a one-stage protocol and reviewed at monthly intervals. NobelActive(TM) implants were functionally loaded with provisional restorations at 1 month and all implants were restored with final crowns 3 months post-implant placement. The implant was assessed using peak insertion torque values, resonance frequency analysis (RFA), clinical parameters, digital subtraction radiography, and cone beam computed tomography. RESULTS: The insertion torque was significantly greater for the NobelActive(TM) implant group (P = 0.02), although no observable difference in RFA values were found. Preliminary results of 6 months follow-up suggest comparable clinical and radiographic healing responses between the test and control implants. Within the limits of the sample population, the survival rates were lower with the test implants, although this difference was not statistically significant. CONCLUSIONS: The NobelActive(TM) implant system requires higher insertion torques and can also achieve greater primary stability compared with a control implant system. Short-term survival and marginal bone levels of NobelActive(TM) and control implants are comparable, although the NobelActive(TM) implant system appeared to be more technique-sensitive.

Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study.

BACKGROUND: Although consensus guidelines recommend insulin progression among patients with type 2 diabetes (T2DM) who fail to meet glycemic targets over time, many fewer patients are progressed than may benefit. We describe the rationale and design of the MOSAIc (Multinational Observational Study Assessing Insulin use) study, a multinational observational cohort study to identify patient-, physician, and health care environment-based factors associated with insulin progression for patients with T2DM in real-world practice. METHODS/DESIGN: We will enroll 4,500 patients with T2DM taking initial insulin therapy for ≥3 months across 175 physician practice sites in 18 countries. Extensive demographic, clinical, and psychosocial data at the patient and physician level and practice site characteristics will be collected at baseline and regular intervals during a 24-month follow-up period. We will use a multivariable logistic regression model to identify predictors of insulin progression and highlight potential opportunities for health behavior intervention to improve insulin progression rates. Secondary outcomes include evaluating factors associated with glycemic control, hypoglycemia, and treatment adherence among patients who do and do not progress beyond their initial insulin therapy and exploring geographic heterogeneity in treatment. DISCUSSION: Practice site and patient recruitment began in 2011 and baseline data will be available in late 2012. The MOSAIC study's longitudinal observational design as well as the breadth and depth of data will be used to explore and quantify predictors of insulin progression and to identify potential opportunities for health behavior intervention in order to improve T2DM treatment and clinical outcomes.

Modeling the long-term cost-effectiveness of the caries management system in an Australian population.

OBJECTIVES: The Monitor Practice Program demonstrated that regular monitoring and noninvasive management of dental caries is effective in reducing the incremental DMFT (decayed, missing, and filled teeth) in patients, within the construct of a 3-year randomized clinical trial. This analysis evaluates the long-term cost-effectiveness of the preventive approach underpinning the Caries Management System, used in the general practice setting and modeled to the Australian population. METHODS: An individual patient-simulation Markov model was developed to compare the long-term costs and outcomes of the Caries Management System versus standard dental care in a hypothetical sample representative of the Australian population. Eight Markov submodels were developed, representing eight molar teeth (excluding wisdom teeth), each consisting of 11 health states simulating the incidence and progression of dental caries, and future interventions such as fillings and crowns. Transition probabilities and costs assigned to health states were based on claims data from the second largest private health insurer in Australia. The economic evaluation was performed from the Australian private dental practitioner perspective. The incremental cost per DMFT avoided was calculated at three time points: 2 years, 3 years, and lifetime. Univariate sensitivity analysis was conducted to test the robustness of the results. RESULTS: The incremental cost per DMFT avoided at 2 years, 3 years, and lifetime was estimated to be $1287.07, $1148.91, and $1795.06, respectively. CONCLUSION: The analysis suggests that the Caries Management System is most cost-effective in patients with a high risk of dental caries.

A valuation of infusion therapy to preserve islet function in type 1 diabetes.

OBJECTIVES: Recent advances in monoclonal antibody therapies offer the prospect of the prevention or amelioration of type 1 diabetes mellitus (T1DM). The present study was designed to capture UK (English and Scottish) preference weights for the process of undergoing infusion therapy and the likely outcomes of treatment for children (8-12 years), adolescents (13-17 years), and adults. METHODS: Vignette descriptions of T1DM health states (describing infusion therapy and reduced insulin need) were constructed based on qualitative interviews with people with type 1 diabetes, clinicians and findings from a literature review. Utilities were elicited for each health state using the standard gamble interview from the general public, adults with diabetes, and parents of children with diabetes. Participants also completed other outcome measures-EQ-5D, Pediatric Quality-of-Life Inventory, and Hyperglycemic Fear Survey. Mixed model analyses were used to estimate the influence on utility of different participant characteristics. RESULTS: Self-report questionnaires indicated the nature and degree of impact of T1DM on adults', adolescents', and children's quality of life, with adolescents reporting the lowest health-related quality-of-life profile of all groups. The mixed model analysis indicated that each health state was a significant predictor of utility and the T1DM participants gave significantly higher utilities compared with the general public (P = 0.02). CONCLUSION: The general public and people with diabetes (or parents of children with diabetes) all place significant value on reducing the need for insulin injections; also, all recognize the disutility of undergoing infusion cycles. These values are suitable for supporting estimates of cost-effectiveness of infusion therapies in T1DM.

Estimating importance weights for the IWQOL-Lite using conjoint analysis.

PURPOSE: Our objective was to estimate preference-based weights for the IWQOL-Lite that reflect the relative importance overweight and obese people place on the domains included in the instrument. METHODS: US residents, 18 years of age or older, who are overweight (BMI=25.0-29.9) or obese (BMI>or=30) completed an online survey instrument consisting of 12 choice questions. The survey included eight attributes: problems doing usual daily activities, physical symptoms, worry about health, low self-esteem, sexual problems, problems moving around or sitting in public places, teasing or discrimination, and problems at work. Ordered probit was used to estimate importance weights for the attributes and levels. RESULTS: Five hundred and two subjects completed the survey. Sexual problem was the most important attribute. The remaining attributes can be ranked on the order of importance as follows: low self-esteem, physical symptoms, daily activities, teasing or discrimination, moving around or sitting, problems at work, and worry about health. CONCLUSIONS: Our results confirm previous findings that weighting the individual items in the IWQOL-Lite by the importance of outcomes to overweight and obese subjects may provide a more meaningful evaluation of the effect of changes in weight on patient well-being than a nonpreference-based measure of HRQOL.

Obstructive sleep apnoea and periodontitis: a novel association?

PURPOSE: Since both obstructive sleep apnoea (OSA) and periodontitis are associated with systemic inflammation and cardiovascular morbidity, we questioned whether there may be an association between these two disorders. MATERIALS AND METHODS: A standard periodontal examination was undertaken in a group of 66 (54 men and 12 women) treatment-naïve patients diagnosed with OSA [apnoea-hypopnoea index (AHI) >5/h] to derive a number of quantitative variables which could then be used to determine the prevalence of periodontitis in a group of patients. RESULTS: The prevalence of periodontitis in our study group was 77-79%, depending on the definition used. This was almost four times that of historical controls derived from a recent national survey. When sleep-related variables were compared against periodontal variables, significant correlations were found between periodontal clinical attachment level and total sleep time. CONCLUSION: Our pilot study suggests that OSA is associated with periodontitis. Further research is needed to elucidate the nature of this association.

Effectiveness of Managing Diabetes During Ramadan Conversation Map intervention: A difference-in-differences (self-comparison) design.

BACKGROUND: Some individuals with diabetes fast during Ramadan despite medical concerns for risk of adverse outcomes. The Managing Diabetes During Ramadan Conversation Map is a self-management education group-based intervention for Muslim individuals with type 2 diabetes, specifically addressing diabetes management during Ramadan. OBJECTIVE: The aim of this study was to evaluate the effectiveness of the Managing Diabetes During Ramadan Conversation Map intervention in improving short-term clinical outcomes and reducing healthcare utilization following Ramadan. DESIGN: This was a retrospective rolling cohort study. SETTINGS: Participants were Clalit Health Services members with type 2 diabetes who participated in the intervention between 2014 and 2017 across Israel. PARTICIPANTS: This study included 1732 participants who enrolled in the intervention over the five-year study period. The cohort was mainly between the ages of 45 and 74 years (83.3%), female (71.9%), of lower socioeconomic status (92.1%), with a diabetes duration of 10 years or more (51.7%), obese (64.0%), and had never smoked (73.8%). METHODS: The data used in this study came from Clalit Health Services' electronic health records, which are integrated in a central data warehouse. We used a difference-in-differences (self-comparison) design to examine the effect of the intervention on changes in laboratory results and healthcare utilization over a six month baseline and follow-up. Mixed model linear regressions and Poisson regressions were used to estimate continuous and count outcomes, respectively. RESULTS: Post intervention, participants experienced a reduction of 8.61 mg/dL in their glucose levels (p = 0.005) and 0.34% in their HbA1c levels (p < 0.001). In a sub-group analysis of participants with HbA1c > 7%, larger reductions in glucose (17.02 mg/dL [p < 0.001]) and HbA1c (0.63% [p < 0.001]) levels were recorded. This sub-group also experienced a reduction of 4.83 mg/dL in LDL level (p = 0.007) and had 0.2 fewer primary care visits (p < 0.001). CONCLUSIONS: Participation in the Managing Diabetes During Ramadan Conversation Map improved patient glucose and HbA1c levels. A greater benefit was reported in those individuals with HbA1c > 7%. These findings hold important global health implications for the millions of individuals with type 2 diabetes for whom Ramadan can pose a challenge in disease control.

The relationship between intensification of blood glucose-lowering therapies, health status and quality of life in type 2 diabetes: The Fremantle Diabetes Study Phase II.

AIMS: To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL). METHODS: We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL. RESULTS: There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P < 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08). CONCLUSIONS: These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.