Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial.

SummaryBackgroundWe aimed to assess whether a structured weight management programme incorporating a total diet replacement (TDR) (3–5 months ∼850 kcal/day formula diet) weight loss phase is acceptable to people of South Asian ethnicity and can achieve type 2 diabetes (T2D) remissions similarly to other populations.MethodsAdults of South Asian ethnicity, aged 18–65 years, with T2D for ≤4 years, and BMI 25–45 kg/m2 were recruited from primary care and social media, and randomised to commence TDR either immediately (iTDR), or delayed (dTDR) for 3–5 months as a usual care control arm during this period. Intervention effects were tested in randomised comparisons powered to detect significant weight loss, and in an expanded observational analysis to determine remission effect size, including both iTDR and dTDR groups. Acceptability in those recruited was explored by questionnaire and weight change.Trial registrationCurrent Controlled Trials, ISRCTN10720065. Date of Registration 27/09/2017.FindingsTwenty-five eligible individuals were recruited. Mean baseline (SD) age was 45.8 (11.1) years, weight 88.2 (13.7) kg, BMI 32.1 (3.8) kg/m2, HbA1c 60.4 (11.3) mmol/mol, liver fat by MRI 15.6 (9.4)%. In the RCT, mean(SD) weight change after TDR was −7.7 (7.2)% in the intervention group (n = 13), and −1.2 (1.4)% in the usual-care control group (n = 12) (p = 0.005), with T2D remission achieved by 5/13, compared to 0/12 respectively (p = 0.039). In the observational study, 23/25 started TDR and 19/23 participants completed the TDR phase. Median time spent in TDR was 105 days (IQR 77–134 days). T2D remission was achieved in 10/23 (43%), and weight changes were concordant with the RCT. Overall, 8/23 (35%) lost over 10% bodyweight. Absolute liver fat proportion near halved from 15.3% at the start of TDR to 8.6% (p < 0.001).InterpretationIn UK-based South Asians, TDR-led weight loss and T2D remission rates are comparable to those observed in white cohorts, and the intervention was acceptable in most of those recruited. There is potential to further improve outcomes, but one-third lost >10% body weight, and the mechanism underpinning T2D remission appears similar, driven by weight change with loss of excess ectopic body-fat.FundingWe gratefully acknowledge funding for the MRI scans from the, Miss MJM Smith Trust (registered charity: SC040586). No other external funds were provided for this trial. NS is supported by the British Heart Foundation Research Excellence Award (RE/18/6/34217).

BackgroundObesity-related complications (ORCs), such as type 2 diabetes (T2D) and cardiovascular disease, contribute considerably to the clinical and economic impacts of obesity. To obtain a holistic overview of health and weight management attempts for people with obesity in Europe, we designed the cross-sectional RESOURCE survey to collect data on comorbidities, healthcare resource use (HCRU) and weight loss strategies from people with obesity in France, Germany, Italy, Spain, Sweden and the UK.MethodsAdults (≥18 years old) with self-reported body mass index (BMI) ≥30 kg/m2 who reported interacting with primary or secondary healthcare services in the past 12 months, but had not been pregnant during this time, were recruited from an existing consumer research panel. All data were self-reported via an online survey (May–June 2021). Weight changes over the past year were calculated from participants’ estimated weights.ResultsOf the 1850 participants in the survey, 26.3% reported that they had ≥3 ORCs from a set of 15 conditions of interest. The most frequently reported ORCs were hypertension (39.3% of participants), dyslipidaemia (22.8%) and T2D (17.5%). Participants in obesity class III (BMI 40 to <70 kg/m2) were more likely to report multiple ORCs than those in lower obesity classes. The presence of multiple ORCs was linked to various types of HCRU, including a significantly increased chance of reporting hospitalization in the past year. Most participants (78.6%) had attempted to lose weight in the past year, but of those who also reported estimated weight changes, 73.4% had not experienced clinically meaningful weight loss of ≥5%.ConclusionsORCs are common in people with obesity, and are linked to increased HCRU. Together with the low reported success rate of weight loss attempts, this highlights an unmet need in Europe for enhanced weight management support for people with obesity.

Aims/hypothesisWeight reduction is fundamental for type 2 diabetes management and remission, but uncertainty exists over which diet type is best to achieve and maintain weight loss. We evaluated dietary approaches for weight loss, and remission, in people with type 2 diabetes to inform practice and clinical guidelines.MethodsFirst, we conducted a systematic review of published meta-analyses of RCTs of weight-loss diets. We searched MEDLINE (Ovid), PubMed, Web of Science and Cochrane Database of Systematic Reviews, up to 7 May 2021. We synthesised weight loss findings stratified by diet types and assessed meta-analyses quality with A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2. We assessed certainty of pooled results of each meta-analysis using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) (PROSPERO CRD42020169258). Second, we conducted a systematic review of any intervention studies reporting type 2 diabetes remission with weight-loss diets, in MEDLINE (via PubMed), Embase and Cochrane Central Register of Controlled Trials, up to 10 May 2021. Findings were synthesised by diet type and study quality (Cochrane Risk of Bias tool 2.0 and Risk Of Bias In Non-randomised Studies – of Interventions [ROBINS-I]), with GRADE applied (PROSPERO CRD42020208878).ResultsWe identified 19 meta-analyses of weight-loss diets, involving 2–23 primary trials (n = 100–1587), published 2013–2021. Twelve were ‘critically low’ or ‘low’ AMSTAR 2 quality, with seven ‘high’ quality. Greatest weight loss was reported with very low energy diets, 1.7–2.1 MJ/day (400–500 kcal) for 8–12 weeks (high-quality meta-analysis, GRADE low), achieving 6.6 kg (95% CI −9.5, −3.7) greater weight loss than low-energy diets (4.2–6.3 MJ/day [1000–1500 kcal]). Formula meal replacements (high quality, GRADE moderate) achieved 2.4 kg (95% CI −3.3, −1.4) greater weight loss over 12–52 weeks. Low-carbohydrate diets were no better for weight loss than higher-carbohydrate/low-fat diets (high quality, GRADE high). High-protein, Mediterranean, high-monounsaturated-fatty-acid, vegetarian and low-glycaemic-index diets all achieved minimal (0.3–2 kg) or no difference from control diets (low to critically low quality, GRADE very low/moderate). For type 2 diabetes remission, of 373 records, 16 met inclusion criteria. Remissions at 1 year were reported for a median 54% of participants in RCTs including initial low-energy total diet replacement (low-risk-of-bias study, GRADE high), and 11% and 15% for meal replacements and Mediterranean diets, respectively (some concerns for risk of bias in studies, GRADE moderate/low). For ketogenic/very low-carbohydrate and very low-energy food-based diets, the evidence for remission (20% and 22%, respectively) has serious and critical risk of bias, and GRADE certainty is very low.Conclusions/interpretationPublished meta-analyses of hypocaloric diets for weight management in people with type 2 diabetes do not support any particular macronutrient profile or style over others. Very low energy diets and formula meal replacement appear the most effective approaches, generally providing less energy than self-administered food-based diets. Programmes including a hypocaloric formula ‘total diet replacement’ induction phase were most effective for type 2 diabetes remission. Most of the evidence is restricted to 1 year or less. Well-conducted research is needed to assess longer-term impacts on weight, glycaemic control, clinical outcomes and diabetes complications.Graphical abstract

BackgroundAtrial fibrillation (AF) is common among patients with obstructive hypertrophic cardiomyopathy (oHCM), although the impact of AF on health care resource use and costs is not well defined.MethodsWe performed a retrospective analysis of claims data from 2016 to 2021 and used International Classification of Diseases, Tenth Revision (ICD‐10) codes to identify adult patients with symptomatic oHCM and classify their status with respect to AF as follows: (1) prevalent AF, (2) incident AF, and (3) no AF. Health care resource use and costs for each cohort were analyzed and expressed as per person per year (PPPY).ResultsOf 22 216 patients with symptomatic oHCM, 6677 had prevalent AF (30.1%), 2879 had incident AF (13.0%), and 12 660 were without AF (57.0%). Patients with incident AF incurred mean total health care costs that were similar to those with prevalent AF but substantially greater than those without AF (mean, $66 619 [95% CI, $59 702–$74 336] versus $63 937 [95% CI, $59 803–$68 356] versus $46 686 [95% CI, $43 901–$49 648] per person per year, P<0.0001). After adjusting for age, sex, major comorbidities, and septal reduction therapy, mean total health care costs remained greater in the groups with incident and prevalent AF than the group without AF, with trends toward even greater relative costs in the group with incident AF. Similar trends were present in adjusted costs related to hospitalizations, surgeries, and urgent care.ConclusionsThe diagnosis of AF in the setting of symptomatic oHCM not only has important implications for patient management but also substantial economic impacts, as it is associated with significantly greater health care costs and resource use relative to patients with symptomatic oHCM and no AF.

The aim of this study was to investigate the association between weight change and healthcare resource use (HCRU) and costs in English primary care patients with type 2 diabetes mellitus (T2DM) initiating treatment with a new diabetes medication class. Patients diagnosed with T2DM initiating a new diabetes medication class (first-line, switch or add-on treatment) were selected from Clinical Practice Research Datalink. Weight change (index date) was measured 6 months after initiating new treatment. HCRU was derived up to 1 year after index. Adjusted analyses evaluated the association between weight change and HCRU and costs (GBP, 2013 prices). Of 9031 patients, about half (n = 4901) experienced < 3% weight change (weight neutral); the proportions gaining or losing weight were similar. Compared with the weight neutral group, weight gain was associated with significantly increased total costs within a year (3.0-5.4% weight gain: £58.9; p = 0.01, ≥ 5.5% weight gain: £52.9; p = 0.04) and diabetes primary care costs (3.0-5.4% weight gain: £29.2; p < 0.001, ≥ 5.5% weight gain: £34.2; p < 0.001). This included increased rates of prescribing drugs for diabetes and, in ≥ 5.5% weight gain, increased primary care contacts. A ≥ 5.5% weight loss was associated with increased hospital admissions (odds ratio = 1.4; p < 0.0001) and total costs (£126.3; p < 0.001). Weight gain after initiating a new glucose-lowering medication is associated with increased prescribing and contact with primary care clinicians, with increased costs in primary care and total spending. This study supports that weight gain in diabetes is associated with increased healthcare costs.

Data on the real-world burden of herpes zoster (HZ) in adults with type 2 diabetes (T2D) in the U.S. are limited. We assessed HZ in patients with and without T2D and measured the impact of HZ on health care resource use (HCRU) and costs. This retrospective cohort analysis used U.S. commercial claims data (sourced from claims incurred between 1 January 2012 and 31 July 2018). HZ incidence rates/1,000 person-years (PYs) were calculated in patients with and without T2D. HZ risk was evaluated using Poisson regression to generate adjusted incidence rate ratios (aIRRs). Patients with T2D with HZ were propensity score matched to patients with T2D only and to patients with HZ without T2D. HCRU and costs were compared across cohorts during a 1-year follow-up period. Cox proportional hazards analyses evaluated factors associated with HZ-related complications. Crude HZ incidence rates in patients with and without T2D were 9.8/1,000 PY and 2.6/1,000 PY, respectively. T2D patients were almost twice as likely to be diagnosed with HZ (aIRR 1.84; 95% CI 1.82-1.85). HZ was associated with increased HCRU and health care costs. At 12 months, unadjusted incremental all-cause health care costs for patients with T2D with HZ versus patients with T2D without HZ were $5,216. The unadjusted incremental HZ-related health care costs for patients with T2D with HZ versus patients with HZ without T2D were $2,726. Age was the most important predictor for HZ-related complications. Given the increased risk of HZ and HCRU and cost burden in patients with T2D, HZ prevention in patients with T2D may be beneficial.

The health care costs and resource use of patients with migraine before and after a quantity limit on sumatriptan was introduced in an HMO were compared. A longitudinal, retrospective review of a medical claims database and a pharmacy claims database was conducted for two six-month periods before and after a monthly limit (four tablets or injections) on sumatriptan reimbursement was instituted at an independent practice association-model HMO in February 1997. Patients with at least one medical claim with a diagnosis code for migraine or at least two pharmacy claims for sumatriptan, methysergide, ergotamine, dihydroergotamine, or an ergotamine combination product in 1996 or 1997 were eligible for inclusion. A total of 557 patients were included in the analysis. Migraine-related medical costs and total medical costs increased 1.5% and 24.4%, respectively; neither change was statistically significant. Physician office visits related to migraine increased by 7.8%. The number of hospital admissions for the cohort increased from three to five, but hospital costs decreased by 55.0%. The overall costs of medications for migraine therapy decreased by 4.5%. There was an 8.2% increase in prescriptions for drugs to treat migraine but a 40.0% decrease in their cost, primarily because of decreased sumatriptan use. There was a 33.9% increase in prescriptions for medications that could be used as prophylaxis for migraine and a 49.6% increase in their cost. Implementation of a monthly limit on sumatriptan decreased an HMO's pharmacy costs but did not significantly alter migraine-related direct medical costs and health care resource use of patients with migraine.

IntroductionCurrently, there is limited knowledge about the experiences and challenges type 2 diabetes (T2D) patients face when intensifying from basal insulin to more complex regimens. The purpose of this study was to examine the experiences of adults with T2D who have been intensified to a basal-bolus insulin regimen, including challenges related to intensification, medication adherence issues, non-persistence, and healthcare resource use related to intensification.MethodsA web-based survey of adults diagnosed with T2D and currently treated with basal insulin was conducted in the UK and the USA. The analysis sample was restricted to respondents with current/recent basal-bolus treatment (n = 398) and divided into three analysis groups: (1) “basal-bolus adherent” (current basal-bolus treatment with at least 90% adherence); (2) “basal-bolus non-adherent” (current basal-bolus treatment with less than 80% adherence); and (3) “stopped bolus” (discontinued bolus in past 12 months).ResultsBasal-bolus non-adherent respondents reported fewer discussions with their healthcare providers (HCPs) before starting bolus and more frequent difficulties with and worries about taking bolus insulin compared to basal-bolus adherent and stopped bolus groups. The most frequently reported reasons for discontinuing bolus were related to the complicated nature of regimen, including too complicated to calculate bolus doses (25.7%), too complicated to regulate food in relation to bolus (20.7%), and too complicated to keep track of taking two different insulins (18.6%). Respondents who stopped bolus reported more frequent HCP visits related to diabetes compared to the basal-bolus adherent and basal-bolus non-adherent groups.ConclusionResults suggest that the complicated nature of basal-bolus therapy contributes to the difficulties that T2D patients have with the regimen and to non-persistence. Physician and patient education may help patients address these treatment challenges to improve basal-bolus adherence and persistence, which could reduce healthcare resource use and costs. Less complex regimens may be appropriate for patients with persistent treatment difficulties.FundingNovo Nordisk A/S.

THU0546 HEALTHCARE COSTS OF NOT ACHIEVING REMISSION IN PATIENTS WITH RHEUMATOID ARTHRITIS

Aims Food allergies impose a large clinical and financial burden on patients and the health care system. However, little is known about the factors associated with health care resource use and costs. The aim of this study was to investigate health care resource use and costs in individuals with food allergies utilizing health care in the United States. Methods We conducted a retrospective analysis of insurance claims data from the Merative MarketScan Research Databases (indexed from 1 January 2015 to 30 June 2022). All-cause and food allergy-related health care resource use, direct medical, and out-of-pocket costs for medical services were estimated for 12 months post-index using International Classification of Diseases [ICD] codes. Results Of 355,520 individuals with food allergies continuously enrolled in a health insurance plan for ≥12 months pre- and post-index, 17% had a food allergy-related emergency department visit and 0.9% were hospitalized. The top patient characteristic associated with all-cause and food allergy-related hospitalizations, all-cause costs, and food allergy-related outpatient visit costs was a Charlson Comorbidity Index score of ≥2. Food allergy-related direct medical and out-of-pocket costs were high among patients with a food allergy-related visit. Out-of-pocket cost per patient per year for outpatient visits, emergency department visits, and hospitalizations had an estimated mean of $1631 for patients with food allergy-related visits, which is ∼11% of the total costs for these services ($14,395 per patient per year). Limitations Study limitations are primarily related to the nature of claims databases, including generalizability and reliance on ICD codes. Nevertheless, MarketScan databases provide robust patient-level insights into health care resource use and costs from a large, commercially insured patient population. Conclusion The health care resource use of patients with food allergies imposes a burden on both the health care system and on patients and their families, especially if patients had comorbidities.

Introduction and Objective: To evaluate the effects of replacing diet beverages (DBs) with water on the durability of weight loss and Type 2 Diabetes (T2D) remission over an 18-month weight management follow-up, which included a 6-month weight loss intervention and a subsequent 12-month weight maintenance program. Methods: 81 adult women with obesity or overweight and T2D, who usually consumed DBs in their diet, were randomly assigned to either substitute with water or continue drinking DBs 5 times/week after their lunch for the 18-month follow-up. Results: The participants who were randomly assigned were included in the study by using an intention-to-treat analysis. After the 18-month follow-up period, significant weight change (mean ± SD) in the water group was observed compared with the DBs group (-6.82 ± 2.73 kg vs. -4.85 ± 2.07kg) (P&amp;lt;0.001). Diabetes remission was achieved in 37/41 (90%) participants of the water group vs. 18/40 (45%) in the DBs group (P&amp;lt;0·0001). There were also significant changes in BMI, fasting plasma glucose, insulin levels, the homeostasis model assessment of insulin resistance, 2h postprandial glucose and serum triglyceride in the water group compared with DBs over the 18 months. Conclusion: Sustained replacement of DBs with water after the main meals in women with T2D may promote further weight reduction during an 18-month weight management program. It may also offer benefits in glycemic control and diabetes remission during the long-term diet plan. Disclosure M. Farshchi Nasr: None. A. Madjd: None. H.R. Farshchi: None.

BackgroundOur aim was to investigate patterns of health care resource use by patients before and after a diagnosis of CFS/ME, as recorded by Clinical Practice Research Datalink (CPRD) GP practices in the UK.MethodsWe used a case–control study design in which patients who had a first recorded diagnosis of CFS/ME during the period 01/01/2001 to 31/12/2013 were matched 1:1 with controls by age, sex, and GP practice. We compared rates of GP consultations, diagnostic tests, prescriptions, referrals, and symptoms between the two groups from 15 years (in adults) or 10 years (in children) before diagnosis to 10 years after diagnosis.ResultsData were available for 6710 adult and 916 child (age <18 years) matched case–control pairs. Rates of GP consultations, diagnostic tests, prescriptions, referrals, and symptoms spiked dramatically in the year when a CFS/ME diagnosis was recorded. GP consultation rates were 50% higher in adult cases compared to controls 11–15 years before diagnosis (rate ratio (RR) 1.49 (95% CI 1.46, 1.52)) and 56% higher 6–10 years after diagnosis (RR 1.56 (1.54, 1.57)). In children, consultation rates in cases were 45% higher 6–10 years before diagnosis (RR 1.45 (1.40, 1.51)) and 62% higher 6–10 years after diagnosis (RR 1.62 (1.54, 1.70)). For adults and children, rates of tests, prescriptions, referrals, and symptoms were higher in cases compared to controls for up to 10 years before and after diagnosis.ConclusionsAdults and children with CFS/ME have greater health care needs than the rest of the population for at least ten years before their diagnosis, and these higher levels of health care resource use continue for at least ten years after diagnosis.

The cost of back pain to the UK economy is considerable inrespect of both direct and indirect health care. In 1998, the directhealth care costs alone were estimated as £1632 million [1]. Asa result, the inclusion of health economic outcomes for muscu-loskeletal disorders is an agreed research priority for non-pharmalogical therapies [2] and vocational rehabilitation [3].Establishing accurate and feasible methods of data collection istherefore essential in studies measuring the effectiveness of backpain rehabilitation.Economic evaluations estimate the costs and benefits of two ormore competing interventions in order to inform resource alloca-tion decision making about the likely value for money. In a fixedbudget national health service, it is important to undertake suchevaluations in order to maximize the efficient use of resourcesandpatientoutcomes.However,theusefulnessofsuchevaluationsdepends on both the quality and availability of the necessary dataupon which they are based. Resource use data and outcomes datacan be collected in a number of ways, including patient self-reportquestionnaires, diaries and interviews, clinical report forms andpatient records. Several studies have investigated the use of alter-native ways of collecting resource use data but findings are mixedas to the most reliable method [4–7]. However, very few of theseeconomicevaluationsdescribehowsuchdatacollectiontoolsweredeveloped, or have compared case notes with self-report for backpain [8].This study describes pilot work conducted in preparation for afeasibility randomized controlled trial of vocational rehabilitationfor low back pain. In the trial, patients were to be recruited from amultidisciplinary group rehabilitation programme for back pain(The Nottingham Back and Pain Team) and randomized into oneof two groups; routine group rehabilitation, or routine group reha-bilitation plus an individually targeted vocational intervention.Aneconomic evaluation was proposed to estimate the comparativecosts and outcomes of the interventions from a national healthservice and social service perspective, the patient perspectivebeing presented separately.Health care resource data are often collected throughself-report, but such methods may not be accurate due to,for example, poor completion rates [9] and recall errors [5].This research letter focuses on the practicability of collectinghealth care resource use data from general practitioner (GP)practices only, as this approach has been shown by some to bemore technically accurate [10]. The feasibility trial would seek tocapture any change in health care resource use following theintervention. Such knock-on data would be used to comparelevels of health care resource use over a set period of time, thatis, 6 months before and 6 months after rehabilitation betweenthose receiving the intervention and those not. Data would becollected retrospectively.The aims of this study were therefore to establish the dataroutinely collected by GPpractices, and how easily this data couldbe extracted for the feasibility trial.

CV3 - The Prevalence and Burden of Hypertension and Obesity Among Patients with Type 2 Diabetes in Japan

BackgroundOne 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.MethodsAn 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.ResultsBaseline 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.ConclusionsIn 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.