While treatment remains essential, disease prevention often proves more effective in improving outcomes, enhancing well-being and reducing healthcare costs. Despite this understanding, preventative medical practices are still underutilized. Continuous monitoring technologies can help to address this gap by enabling early symptom detection, tracking disease recurrence and assessing treatment responses, yet few of the technologies have been integrated into clinical practice. In this Review, we discuss notable advances in continuous monitoring and the barriers to their translation. We focus on technologies that enable either continuous measurement for at least one week or periodic measurements for at least one month, including remotely interfacing technologies, wearables and other directly interfacing systems, and internally interfacing implanted devices. Continuous monitoring improves disease-risk assessment, tracks disease progression and enhances overall health management. However, broader and more reliable datasets from diverse clinical trials, alongside supportive policies and financial incentives, will be essential to overcoming translational barriers and to integrating these technologies into healthcare. This Review discusses how continuous monitoring technologies can enable early symptom detection, disease recurrence tracking and treatment response assessment, and how these technologies are being integrated into clinical practice.
To examine the efficacy of a telehealth based approach to effective weight management interventions in women with obesity seeking treatment for infertility.
Glycemic control through titration of insulin dosing remains the mainstay of diabetes mellitus treatment. Insulin therapy is generally divided into dosing with long -and short-acting insulin, where long-acting insulin provides basal coverage and short-acting insulin supports glycemic excursions associated with eating. The dosing of short-acting insulin often involves several steps for the user including blood glucose measurement and integration of potential carbohydrate loads to inform safe and appropriate dosing. The significant burden placed on the user for blood glucose measurement and effective carbohydrate counting can manifest in substantial effects on adherence. Through the application of computer vision, we have developed a smartphone-based system that is able to detect the carbohydrate load of food by simply taking a single image of the food and converting that information into a required insulin dose by incorporating a blood glucose measurement. Moreover, we report the development of comprehensive all-in-one insulin delivery systems that streamline all operations that peripheral devices require for safe insulin administration, which in turn significantly reduces the complexity and time required for titration of insulin. The development of an autonomous system that supports maximum ease and accuracy of insulin dosing will transform our ability to more effectively support patients with diabetes.
Aims: Insulin potentiates glucose-stimulated insulin secretion. These effects are attenuated in beta cell-specific insulin receptor knockout mice and insulin resistant humans. This investigation examines whether short dura-tion insulin exposure regulates beta cell responsiveness to arginine, a non-glucose secretagogue, in healthy humans. Materials and methods: Arginine-stimulated insulin secretion was studied in 10 healthy humans. In each subject arginine was administered as a bolus followed by continuous infusion on two occasions one month apart, after sham/saline or hyperinsulinemic-isoglycemic clamp, respectively providing low and high insulin pre-exposure conditions. Arginine-stimulated insulin secretion was measured by C-peptide deconvolution, and by a selective immunogenic (DAKO) assay for direct measurement of endogenous but not exogenous insulin. Results: Pre-exposure to exogenous insulin augmented arginine-stimulated insulin secretion. The effect was seen acutely following arginine bolus (endogenous DAKO insulin incremental AUC(240-255min) 311.6 +/- 208.1 (post-insulin exposure) versus 120.6 +/- 42.2 mu U/ml.min (sham/saline) (t-test P = 0.021)), as well as in response to continuous arginine infusion (DAKO insulin incremental AUC(260-290min) 1095.3 +/- 592.1 (sham/saline) versus 564.8 +/- 207.1 mu U/ml.min (high insulin)(P = 0.009)). Findings were similar when beta cell response was assessed using C-peptide, insulin secretion rates by deconvolution, and the C-peptide to glucose ratio. Conclusions: We demonstrate a physiologic role of insulin in regulation of the beta cell secretory response to arginine. (c) 2022 Elsevier Inc. All rights reserved.
To improve the power of mediation in high-throughput studies, here we introduce High-throughput mediation analysis (Hitman), which accounts for direction of mediation and applies empirical Bayesian linear modeling. We apply Hitman in a retrospective, exploratory analysis of the SLIMM-T2D clinical trial in which participants with type 2 diabetes were randomized to Roux-en-Y gastric bypass (RYGB) or nonsurgical diabetes/weight management, and fasting plasma proteome and metabolome were assayed up to 3 years. RYGB caused greater improvement in HbA1c, which was mediated by growth hormone receptor (GHR). GHR's mediation is more significant than clinical mediators, including BMI. GHR decreases at 3 months postoperatively alongside increased insulin-like growth factor binding proteins IGFBP1/BP2; plasma GH increased at 1 year. Experimental validation indicates (1) hepatic GHR expression decreases in post-bariatric rats; (2) GHR knockdown in primary hepatocytes decreases gluconeogenic gene expression and glucose production. Thus, RYGB may induce resistance to diabetogenic effects of GH signaling.Trial Registration: Clinicaltrials.gov NCT01073020.
An NEJM Catalyst Insights Council survey finds many challenges in treating obesity and limited effectiveness.
Results Summary Download Summary Español (pdf) Audio Recording (mp3) Results Summary What was the research about? Patients who are above a healthy weight may benefit from weight loss support. But doctors have limited time during clinic visits to support weight management. In this study, the research team compared three ways to help patients manage their weight outside the clinic: BMIQ. BMIQ is an online weight management program with meal plans, menus, and a weight tracker. It also includes 33 educational sessions on topics such as coping with food cravings and learning portion control. BMIQ is available in English and Spanish. BMIQ plus support from a health manager. The health manager checked patients’ progress with BMIQ, called patients monthly, and offered patients brief meetings with a dietitian. The health manager also reached out to patients if they didn’t watch educational sessions or track their weight on BMIQ. Usual care. Patients received written information about weight management by mail, including general advice about exercise and healthy eating. What were the results? After one year, patients using BMIQ plus support lost more weight than patients using BMIQ alone or those receiving usual care. On average, patients using BMIQ plus support lost about seven pounds. Patients using BMIQ alone lost about four pounds, and patients receiving usual care lost about three. Compared with both usual care and BMIQ alone, BMIQ plus support also had greater increases in Percent weight change Proportion of patients who lost at least 5 percent of their weight Confidence in ability to lose weight Patients in the three groups didn’t differ in changes in Quality of life related to their weight How healthy they felt Risk factors for heart disease, such as blood pressure or blood sugar levels The types of foods they ate or how often they exercised After 18 months, changes were similar, except weight loss, which was greater in patients who received usual care than in those who received BMIQ alone. Who was in the study? The study included 840 patients with high blood pressure or type 2 diabetes who had overweight or obesity. Of these, 76 percent were white, 10 percent were black, and 5 percent reported another race; also, 6 percent were Hispanic. The average age was 59, and 60 percent were women. Patients received care at 1 of 24 primary care clinics in the Boston area. What did the research team do? The research team assigned clinics by chance to use BMIQ, BMIQ plus support, or usual care. Patients used the method assigned to their clinic. At the start of the study and again 6, 12, and 18 months later, the team looked at health records, and patients completed surveys. Patients, caregivers, and healthcare professionals gave input on the study. What were the limits of the study? The study didn’t have enough patients to detect differences in some outcomes. All patients in the study had high blood pressure or type 2 diabetes. Future studies could include patients with other health problems. How can people use the results? Clinics can use the results when considering ways to offer weight management support. Professional AbstractProfessional AbstractObjective To compare the effectiveness of an online program alone, the online program plus population health management support, and usual care on improving patients’ weight management Study Design Design Element Description Design Cluster randomized trial Population 840 patients with hypertension or type 2 diabetes and BMI between 27 and 40 who received care at primary care clinics Interventions/ Comparators Online weight management program alone Online weight management program plus population health management support Usual care Outcomes Primary: change in body weight at 12 months Secondary: change in body weight at 6-month and 18-month follow-up; percent weight change; weight loss ≥5%; changes in cardiovascular risk factors; changes in patient-reported health, diet, physical activity, weight-related quality of life, and confidence in ability to lose weight Timeframe 1-year follow-up for primary outcome This pragmatic cluster randomized trial compared the effectiveness of an online weight management intervention called BMIQ, BMIQ plus population health management support, and usual care on reducing body weight. Researchers randomized 24 primary care clinics to one of three groups. Patients used the method assigned to their clinic. BMIQ alone. BMIQ included meal plans and menus; a tracking system for weight, diet, and physical activity; and 33 educational sessions delivered over one year on topics such as navigating food cravings and reinforcing portion control. BMIQ was available in English and Spanish. BMIQ plus population health management support. This combined intervention included a non-clinical population health manager who monitored patients’ progress with BMIQ, called patients monthly for support, and offered brief consultations with a registered dietitian. The population health manager also had access to patients’ BMIQ interface and reached out to patients if they fell behind with tasks such as viewing educational sessions or tracking their weight. Usual care. Patients received written information by mail about weight management, including general recommendations about diet and physical activity. The study included 840 patients with hypertension or type 2 diabetes and a body mass index (BMI) between 27 and 40. Of these, 76% were white, 10% were black, and 5% reported another race; also, 6% were Hispanic. The average age was 59, and 60% were female. Patients received care at 1 of 24 primary care clinics in the Boston area. Researchers collected data from electronic health records and patients completed surveys at baseline and again 6, 12, and 18 months later. Patients, caregivers, and healthcare providers helped design the study and patient surveys. Results After one year, patients receiving the combined intervention lost more weight than patients receiving BMIQ alone (p=0.01) or usual care (p<0.001). Average weight loss was approximately seven pounds for patients receiving the combined intervention, four pounds for those receiving BMIQ alone, and three pounds for those receiving usual care. Compared with both usual care and BMIQ alone, the combined intervention had greater increases in Percent weight change (p<0.001) Proportion of patients who had at least 5% weight loss (p<0.001) Confidence in ability to lose weight (p<0.001) The three groups did not differ significantly in other secondary outcomes after one year. At 18 months, changes in weight and other outcomes were similar, except weight loss, which was greater among patients who received usual care than among those who received BMIQ alone. Limitations The study may have been underpowered to detect meaningful differences in secondary outcomes. All patients had hypertension or type 2 diabetes. Findings may differ for patients with other health conditions. Conclusions and Relevance In this study, BMIQ plus population health management support resulted in more weight loss after one year than BMIQ alone or usual care. Future Research Needs Future research could include populations with other health conditions.
BackgroundScalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.MethodsWe adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m2, and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.ResultsWe enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m2; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.ConclusionIt is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings.ClinicalTrials.gov registration number: NCT02656693
Eliciting a weight history can provide clinically important information to aid in treatment decision‐making. This view is consistent with the life course perspective of obesity and the aim of patient‐centered care, one of six domains of health care quality. However, thus far, the value and practicality of including a weight history in the clinical assessment and treatment of patients with obesity have not been systematically explored. For these reasons, the Clinical Committee of The Obesity Society established a task force to review and assess the available evidence to address five key questions. It is concluded that weight history is an essential component of the medical history for patients presenting with overweight or obesity, and there are strong and emerging data that demonstrate the importance of life stage, duration of exposure to obesity, maximum BMI, and group‐based trajectory modeling in predicting risk for increased morbidity and mortality. Consideration of these and other patient‐specific factors may improve risk stratification and clinical decision‐making for screening, counseling, and management. Recommendations are provided for the key elements that should be included in a weight history, and several needs for future clinical research are outlined.
Objective: Deposit contracts, where participants "bet" on achieving a goal and get their money back only if successful, have been shown to be effective for short-term weight-loss. This pilot study examined their effect on weight-loss maintenance. Methods: From 2016 to 2018, we conducted a pilot, 50-week randomized controlled trial among 42 hospital employees (19 intervention and 23 control), in Boston, Massachusetts, who lost >= 10 lb (4.5 kg) in the two years prior to enrollment. Participants were recruited primarily in-person. Both control and intervention participants were asked to attend a weigh in weekly and received weekly email communication. Intervention participants also entered into a deposit contract to maintain baseline weight within <= 2 lb (0.9 kg). We examined weight change from baseline to 50 weeks (primary outcome) and maintenance of baseline weight at 50 weeks (secondary outcome; binary - yes v. no). Participants completed baseline and follow-up surveys and received incentives for completion. Results: At baseline, mean (SD) weight was 83.2 (15.5 kg) among intervention and 80.7 (14.5 kg) among control participants. After 50 weeks, intervention participants had slightly less but non-significant weight gain (adjusted beta -1.12 kg; 95% CI -5.28, 3.05) than control participants; 73.7% of intervention v. 39.1% of control participants met their weight-loss maintenance goal by study end (adjusted OR 4.78; 95% CI 1.01, 22.71). Conclusions: A deposit contract was not associated with differences in weight but led to more participants meeting their weight-loss maintenance goals; a deposit contract for weight-loss maintenance should be tested in a full-scale intervention. Most intervention participants viewed the deposit contract as acceptable.
Importance Online programs may help with weight loss but have not been widely implemented in routine primary care. Objective To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care. Design, Setting, and Participants Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019. Interventions Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach. Main Outcomes and Measures The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome. Results Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001). Conclusions and Relevance Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings. Trial Registration ClinicalTrials.gov Identifier: NCT02656693.
BACKGROUND:Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity. OBJECTIVES:This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program. SETTING:University medical center, United States. METHODS:Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m2; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22). RESULTS:At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies. CONCLUSIONS:Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.
Oral semaglutide, which has undergone multiple phase 3 clinical trials, represents the first oral biologic medication for type 2 diabetes in the form of a daily capsule. It provides similar efficacy compared with its weekly injection counterpart, but it demands a dose on the order of 100 times as high and requires more frequent administration. We perform a cost effectiveness analysis using a first and second order Monte Carlo simulation to estimate quality-adjusted life expectancies associated with an oral daily capsule, oral weekly capsule, daily injection, and weekly injection of semaglutide. We conclude that the additional costs incurred to produce extra semaglutide for the oral formulation are cost effective, given the greater quality of life experienced when taking a capsule over a weekly injection. We also demonstrate that the potency of semaglutide allows the formulation to be cost effective, and less potent drugs will require increased oral bioavailability to make a cost effective oral formulation.