Staff Writer

The push to use technology to improve medication adherence is at the heart of a new pilot program between the California-based digital health firm 

 Plan, the largest publicly operated health plan in the United States.

The two entities last month announced that they will partner together on a six month project to see how Custom Health’s suite of services can improve the healthcare of 100 special needs patients.

®, he believes the partnership will help LA Care better manage the cost of care and healthcare outcomes of patients, while also creating a data set to demonstrate the benefits of the program.

“We are confident that with our integrated systems, there will be benefits for both the health plan and the individuals they serve,” he said.

Custom Health is part of a growing number of adherence-focused technology companies. The company is selling an integrated delivery model that a variety of digital tools that both track when patients take their medications and monitor important health metrics, such as blood pressure and blood glucose. Those data can help the company’s team of in-house pharmacists monitor patients and intervene as needed.

Yana Paulson, PharmD, LA Care’s chief pharmacy officer, said the central role of pharmacists in Custom Health’s model was attractive.

“We know pharmacist-led service delivery increases medication adherence, so we're thrilled to have Custom Health's know-how to provide personalized care to our members,” Paulson said, 

 that one of the key goals with regard to the particular patients in the pilot program is to help ensure reliable access to patient medication.

“In terms of the opportunities we see for helping this unique population, we hope that for those that have difficulties with transportation to access medication, we eliminate that barrier and bring their prescription medicines to them, then we help them stay adherent with customized care and real-time clinical oversight using data and our digital health tools and services,” Chopra said.

The deal closed out a busy year for Custom Health. In September, the company 

 to Custom Health from its original name, Pack4U, in order to reflect its broader focus on data-driven personalized care. Later that month, the firm 

 the software company Health in Motion Network.

Chopra said he believes now is an important moment in terms of solving the persistent problem of patient non-adherence.

“Adherence is the first line of the care system,” he said. “The industry standards in adherence are quite sparse and only partially represent patient needs.”

However, he said the solution to improving patient adherence is not just about using devices to track when medications are taken or compiling data to help understand when and why patients miss doses. Rather, he believes the solution will be about leveraging all of those tools together in order to holistically understand and address the unique reasons for non-adherence on a patient-by-patient level.

“Our proprietary end-to-end systems not only track medications, but they also help our team understand if medications are doing what they should and take action to course correct if they are not,” he said. “We stop the guesswork when it comes to medication.”

This article originally appared on Managed Healthcare Executive.

Articles

Custom is one of the growing number of companies focusing on adherence. It changed its name from Pack4U last year.

Pilot Program From Custom Health, L.A. Care, Tackles Medication Adherence

Sight Sciences Inc. today reported independent data addressing a frequent question from eyecare practitioners and patients regarding the treatment of meibomian gland disease (MGD) using the TearCare System: How long does a single treatment last?

According to the company, clinical outcomes for 78 dry eye patients (156 eyes) treated at a single center, the Cleveland Eye Clinic, showcased the duration of efficacy of a single, first-time treatment of MGD using the TearCare System.

Moreover, the news release noted that patients throughout the study exhibited improved dry eye signs and symptoms for more than 12 months, and in some cases up to 18 months, post treatment. The study was a retrospective, investigator-initiated trial (IIT) reviewing clinical outcomes for patients who had been treated with the TearCare system at least 12 months prior to data collection.

Further, it was noted in the news release that data showed that patients experienced a 44% decrease in dry eye symptoms from baseline to week 8, suggesting a fast onset of action from TearCare. This symptom reduction was maintained through month 12, further suggesting sustained long-term improvements associated with the use of the TearCare System. In some patients, these therapeutic benefits were maintained through 18 months.

For this study, all patient data were collected from medical records retrospectively with no prospective intervention. Patients’ symptoms were assessed at a single time point pre-treatment and at four time points post-treatment (8-12 weeks, 6 months, 12 months, and 18 months). Patients treated with therapies other than TearCare within the 12-month window, including ophthalmic prescription medications, were excluded. In total, data from 78 patients (156 eyes) who had been treated with the TearCare system and who returned for post-treatment follow up were included in the analysis.

Results of the trial showed most subjects experienced at least 12 months of gland function improvement and decreased symptoms. Standard Patient Evaluation of Eye Dryness (SPEED) score data decreased approximately 6.2 points, from 14.1 ± 6.5 to 7.9 ± 5.7, at eight weeks after treatment and was maintained up to 12 months post-treatment, indicating a positive treatment outcome. In addition, the average meibomian gland expression (MGE) score increased 4 points post-treatment from baseline of 4.9 ± 2.6 in the right eye and 4.8 ± 2.4 in the left eye to 9.0 ± 2.7 (

 < 0.001) in the right eye and 9.0 ± 2.9 (

< 0.001) in the left eye (measured at 8 weeks post-treatment) and remained at least 3 points higher from baseline over the course of a year with a month 12 score of 7.8 ± 1.7 (

 <0.001) in the right eye and 7.8 ± 1.4 (

 < 0.001) in the left eye, again suggesting positive treatment outcomes in the signs of dry eye.

“Sight Sciences is committed to redefining the treatment paradigm for dry eye, a disease that until now has primarily been treated by prescription eye drops and artificial tears,” said Paul Badawi, CEO of Sight Sciences. “Considering only approximately 5% of dry eye patients currently receive interventional MGD procedures such as TearCare for the treatment of their dry eye,

 we believe these clinical data demonstrate the durability of treatment effect with TearCare and will support greater adoption of the procedure.

Badawi pointed out that interventional procedures for dry eye not only address the often mismatched mechanism of action of commonly prescribed Rx that typically target aqueous deficiency when most dry eye patients are suffering from accelerated tear evaporation due to MGD

 but they also help address patient compliance issues and the high monthly costs of daily prescription medications.

“Since the use of the TearCare System helps address the root underlying cause of obstructive MGD and evaporative dry eye, and since our growing body of clinical data suggest that such use confers durable efficacy advantages for many patients, we believe it will transform how dry eye is treated in the future,” he concluded.

The company noted in the news release that its objective is that these long-term efficacy findings, along with the ongoing prospective SAHARA RCT (NCT04795752) directly comparing the TearCare system with Restasis in the first ever large-scale device versus drug RCT, will provide payors with evidence in support of insurance coverage for TearCare along with a provider reimbursement pathway.

This article originally appeared on Ophthalmology Times.

Market Scope 2021: Ocular Surface Disease Survey

Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. 

. 2012;31(5):472-478. doi:10.1097/ICO.0b013e318225415a

According to the company, clinical outcomes for 78 dry eye patients treated at a single center, the Cleveland Eye Clinic, showcased the duration of efficacy of a single, first-time treatment of MGD using the TearCare System.

Dry Eye Improvement from Single TearCare Treatment Sustained Through 12 Months

New data suggests empagliflozin (Jardiance) use was associated with significant improvements in glycemic control among pediatric patients with type 2 diabetes.

December 7 statement from Eli Lilly and Company

, results of the phase 3 DINAMO trial indicate use of empagliflozin was associated with a statistically significant reduction in HbA1c and also with a clinically meaningful reduction in fasting plasma glucose among a population of patients aged 10-17 years of age living with type 2 diabetes.

"Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it's important to recognize and treat diabetes early in its course," said Lori Laffel, MD, principal investigator of the DINAMO study and chief of the Pediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, in Eli Lilly and Company’s statement. "Today's results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor Jardiance compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes. These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin is the only globally available oral treatment for youth."

As the prevalence of type 2 diabetes continues to rise in adults and pediatric populations, the introduction of a therapy with the potential cardiorenal benefits, such as those demonstrated in EMPA-Kidney and EMPEROR-Reduced, for pediatric populations could stand to provide substantial benefit on a population level. Named the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO), the trial enrolled children and adolescents aged 10-17 years with type 2 diabetes an HbA1c equal to or greater than 6.5% and equal to or less than 10.5%. These participants underwent subsequent screening and randomized in a 1:1:1 manner to linagliptin 5 mg, placebo therapy, or empagliflozin in a 10 or 25 mg dose.

Overall, 262 participants underwent screening and 158 underwent randomization. Of these 158, 52 were randomized to Empagliflozin, 53 were randomized to linagliptin, and 53 were randomized to placebo therapy. Of note, all patients in the trial were treated with diet and exercise plus metformin and/or insulin or no background if considered to be metformin intolerant. The primary endpoint of interest in the trial was change in HbA1c at 26 weeks. The trial also included multiple secondary endpoints examining efficacy and safety.

Upon analysis, results of the trial demonstrated use of empagliflozin was associated with a 0.84% reduction in HbA1c relative to placebo therapy at week 26 (95% CI –1.50 to –0.19; 

=.012). The release form Eli Lilly and Company noted use of linagliptin was not associated with a statistically significant reduction in HbA1c compared with placebo therapy, with a numerical reduction of 0.34% (

In an analysis of secondary endpoints, results indicated use of empagliflozin was associated with a 35.2 mg/dL reduction in fasting plasma glucose (

=.0035). In their release, Eli Lilly and Company pointed out the overall safety data from DINAMO was generally consistent with findings in adults with type 2 diabetes.

“The rise in the prevalence of type 2 diabetes in the pediatric population highlights a clear unmet need,” said Jeff Emmick, MD, PhD, vice president, Product Development, Eli Lilly & Company, in the aforementioned release. “Having overcome the challenges in recruitment and design that pediatric trials tend to face, the outcomes of DINAMO represent another positive step forward in Boehringer Ingelheim and Lilly’s commitment to improve the lives of people living with cardio-renal and metabolic conditions such as type 2 diabetes.”

This study, “Diabetes study of Linagliptin and Empagliflozin in Children and Adolescents,” was presented at the International Diabetes Federation World Diabetes Congress 2022.

This article originally appeared on Endocrinology Network.

Eli Lilly and Company and Boehringer Ingelheim announced their SGLT2 inhibitor, empagliflozin, was associated with statistically significant reductions in HbA1c relative to placebo therapy among a population of pediatric patients with type 2 diabetes in the DINAMO trial.

Phase 3 Trial Shows Benefit of Empagliflozin for Pediatric Type 2 Diabetes

In one of the largest studies on long COVID from the United Kingdom since the pandemic began, a new analysis suggests those with an increased body mass index (BMI) and women were more likely to experience long COVID.

A community-based, web-survey study conducted in Norfolk, East England, results of the 1487-patient study demonstrate men had a 25% lower risk of post-COVID symptoms compared to women and each 1 kg/m2 increase in BMI was associated with a 3% increase in risk.

“We show that more than a half of the survey respondents who tested positive for Covid in the East of England during the first year of the pandemic went on to report long Covid symptoms,” said Vassilios Vassiliou, MD, PhD, a clinical professor of cardiac medicine atthe University of East Anglia’s Norwich Medical School, 

 “All of these people were infected in the months before the Covid vaccination programme was rolled out and they suffered from numerous new symptoms that were not present before their Covid infection.

As wave after wave of the pandemic came and went, the prominent focus among researchers and clinicians has changed as well. From use of masks to prevent spread, to the risk of thrombosis with vaccines or infection, and more, the focus for many has, now, shifted to the effects of long COVID and potential risk factors for predicting those with increased susceptibility to long COVID symptoms following infection.

Vassiliou and a team of colleagues designed the current study with the intent of developing a more comprehensive understanding of long COVID in the area surrounding University of East Anglia. With this in mind, investigators created a web-based survey that was sent to patients in Protect Norfolk and Waveney post-COVID-19 syndrome Project, which included adults with a confirmed COVID-19 infection via RT-PCR prior to December 6, 2020. This survey contains questions related to both pre-COVID health and post-COVID symptoms as well as questions pertaining to healthcare use.

The survey was sent to 6318 patients and responses were obtained from 23.5% (n=1487) of this cohort. At the time of the survey, 11 respondents had received their first dose of the COVID mRNA BNT162b2 vaccine. The cohort of respondents had a mean age of 50 (SD, 18.1), 61% were female, and, among the 879 with BMI measurements available, the mean BMI was 28.4 (SD, 6.9) kg/m2. Of the 1487 respondents, 774 experienced post-COVID-19 syndrome symptoms.

For the purpose of analysis, investigators used logistic regression analysis to estimate associations between potential predictors for long COVID symptoms and future healthcare utilization. Investigators pointed out baseline characteristics of the study cohort were obtained from National Health Service digital databases.

Upon analysis, results indicated male sex compared to female sex was considered a protective factor against post-COVID symptoms (RR, 0.748 [95% CI, 0.605-0.924]) while BMI was associated with an increased risk of developing symptoms (Per 1 kg/m2: RR, 1.031 [95% CI, 1.016-1.047]). Of the 1487 respondents, 25.4% reported use of health care services following their index COVID-19 infection, with 73.2% of these patients reporting post-COVID symptoms.

When assessing factors associated with further health care service use, results suggested male sex (RR, 0.618 [95% CI, 0.464-0.818]) was associated with a reduction in risk while BMI (RR, 1.027 [95% CI, 1.009-1.046]) was associated with an increased likelihood of using further health care services. Investigators highlighted experiencing post-COVID-19 symptoms was associated with a more than 3-fold increase in likelihood of using health care services (RR, 3.280 [95% CI, 2.540-4.262]).

“We hope that our work will help policymakers plan local services and also inform the wider public of the scale of the long COVID pandemic,” Vassiliou added in the aforementioned statement.

1. Debski M, Tsampasian, Haney S, et al. Post-COVID-19 syndrome risk factors and further use of health services in East England. P

 2(11):e0001188. doi: 10.1371/journal.pgph.0001188

A new analysis suggests those with an increased body mass index and women were more likely to experience long COVID

Increased Likelihood of Long COVID Linked to Increased BMI, Female Sex

A new analysis of data from medical centers associated with Johns Hopkins Comprehensive Diabetes Center is underlining the existing racial disparities regarding 

continuous glucose monitoring (CGM) and insulin pumps

A retrospective analysis of data recorded from April 2013-January 2020, results of the study suggest Black patients with type 1 diabetes were not only less likely to receive a CGM system or insulin pump but also less likely to have their provider engage in discussions around use of newer diabetes technologies in analyses adjusted for social determinants of health and diabetes outcomes.

“Our findings revealed marked racial disparities in diabetes technology discussions, prescribing, and use in adults with [type 1 diabetes]. Further qualitative and well-designed prospective studies incorporating the perspectives of patients are needed to elucidate the causes behind these disparities in order to develop, implement, and evaluate strategies to reduce them,” wrote investigators.

Since the advent of CGM and insulin pumps into treatment algorithms for people with type 1 diabetes, mountains of data have emerged detailing the benefits of these technologies in management of type 1 diabetes. Despite the proven benefits on glycemic control and quality of life, suboptimal uptake reduces the potential population-level impact this technology could provide. With previous data outlining race-based disparities among diabetes technology uptake among children and adolescents with type 1 diabetes, a Johns Hopkins University School of Medicine-led team launched the current study to provide an overview of racial disparities related to diabetes technology among adults with type 1 diabetes receiving care at four diabetes clinics associated with the Johns Hopkins Comprehensive Diabetes Center.

A retrospective analysis focused on those who received care from April 2013-January 2020, investigators designed their analyses to examine baseline and prevalent technology use, rates of diabetes technology discussions, and prescribing of CGM systems and insulin pumps, with race categorized as Black and non-Black. For the purpose of analysis, investigators used multivariable logistic regression analysis to estimate associations of technology prescribing and discussions with patient race, with adjustment for social determinants of health and diabetes outcomes. Investigators noted CGM systems and insulin pumps were assessed separately.

Overall, 1258 patients were identified for inclusion in the current study. This cohort had a median age of 36 (IQR, 26-52) years and a median diabetes duration of 17 (IQR, 7-27) years. Of the 1258 included in the study, 19.2% were Black. Compared to their non-Black counterparts, Black adults with type 1 diabetes had fewer diabetes clinic visits (6 vs 7), more hospitalizations for diabetic ketoacidosis or hyperosmolar hyperglycemic state (10.4% vs 2.4%) and hypoglycemia (9.5% vs 2.0%), higher A1C levels (9.0% vs 7.5% for first HbA1c; 8.7% vs 7.4% for last HbA1c), and higher prevalence of microvascular complications (53.1% vs 36.5%).

Significantly lower baseline technology use was observed for both CGM (7.9% vs 30.3%) and insulin pumps (18.7% vs 49.6%) for Black patients compared with non-Black patients. Analysis of prevalent use revealed a similar trend, with CGM use observed among 43.6% of Black patients and 72.1% of non-Black patients and insulin pump use observed among 30.7% of Black patients and 64.2% of non-Black patients. When assessing CGM specifically, results indicated Black patients were 49% (aOR, 0.51 [95% CI, 0.29-0.90]) less likely to have a discussion around CGM with a provider and 39% (aOR, 0.51 [95% CI, 0.29-0.90]) less likely to receive a prescription for a CGM system. When assessing insulin pumps specifically, results indicated Black patients were 26% (aOR, 0.74 [95% CI, 0.44-1.25]) less likely to have a discussion around insulin pump use and 60% (aOR, 0.40 [95% CI, 0.22-0.70]) less likely to receive a prescription for an insulin pump.

“Prospective studies should assess the impact of provider type, training, and experience, racial concordance of provider and patient, quantity/quality of provider-patient discussions, patient sustained use of technologies, and ethnic disparities on technology use,” investigators concluded.

1. Kanbour S, Jones M, Abusamaan MS, et al. Racial disparities in access and use of diabetes technology among adult patients with type 1 diabetes in a US academic medical center. 

. 2022 Nov 15;dc221055. doi: 10.2337/dc22-1055.

New research adds more evidence of Black patients facing disparities in diabetes care.

Black Patients Face Disparities for CGMs, Insulin Pumps

Each course of antibiotics during young adulthood was associated with a 2-4% increase in risk of developing type 2 diabetes, according to the results of a new analysis.

Using data from the Cardiovascular Risk in Young Finns Study (YFS) and the national FINRISK study, investigators determined each additional exposure to an antibiotic course was associated with increased risk of subset type 2 diabetes in both studies, with exposure to 5 or more courses associated with a potential doubling in risk of type 2 diabetes later in life.

“The results of this study show that prior exposure to systemic antibiotics was associated with increased risk of incident type 2 diabetes in more than 25,000 participants. Furthermore, prior exposure to antibiotics was also associated with overweight/obesity. The observed risks persisted even after adjustment for numerous potential confounding factors, including BMI at baseline,” wrote investigators.

As more and more data emerge detailing the impact of antibiotic exposure on intestinal microbiome and overall health, some have hypothesized these changes could contribute to increased risk of developing diabetes. The current study was born out of an interest in exploring the potential impact of antibiotic exposure on type 2 diabetes risk using data from the YFS and FINRISK studies.

Launched in 1978, the YFS 2209 participants aged 24-39 years in 2001 with data available related to exposure to antibiotic courses from 1993-2001, which provided investigators with information from 2209 individuals. Of these, 110 patients were diagnosed with diabetes. Using information obtained from clinical examinations conducted in 2001, 2007, and 2011, investigators assessed prevalence of diabetes beginning in and after 2001, with those with prevalent diabetes excluded from the analyses. For the purpose of analysis, investigators used 4 population-based cohorts derived from the National FINRISK studies for replication. These 4 population-based cohorts included 24,674 individuals. Of these, 1866 had incident diabetes. Overall, the total study cohort included 26,883 participants.

Upon analysis, investigators found prior antibiotic exposure, which was defined as more than 5 antibiotic courses, was associated with an increased likelihood of developing type 2 diabetes in both the YFS (OR, 2.29 [95% CI, 1.33-3.96]) and the FINRISK cohorts 

 compared to their counterparts with 1 or fewer antibiotic course exposures. When assessing the impact of exposure per course, results indicated each antibiotic course was associated with a 4% increase in likelihood of type 2 diabetes in the YFS cohort (OR, 1.043 [95% CI, 1.013-1.074]) and a 2% increase in likelihood in the FINRISK cohort (HR, 1.022 [95% CI, 1.016-1.029]).

Further analysis, which assessed risk of overweight/obesity associated with exposure to antibiotics, suggested exposure to antibiotics was associated with a 4% increase in likelihood of overweight/obesity in the YFS cohort (OR, 1.043 [95% CI, 1.019-1.068]) at the 10-year follow-up and a 2% increase in likelihood of overweight/obesity in the FINRISK cohort (OR, 1.023 [95% CI, 1.018-1.029]) at baseline. Investigators pointed out additional adjustments for confounders from early life in YFS and at baseline in FINRISK did not have an appreciable impact on the aforementioned findings.

“We found that prior exposure to systemic antibiotics was associated with increased risk for future type 2 diabetes and overweight and obesity. Our findings support judicious use of antibiotics. Future studies are needed to further investigate the relationship between antibiotic exposure and type 2 diabetes and excess body weight as well as to examine the direct impact of antibiotic exposure on human gut microbiome.”

1. Nuotio J, Niiranen T, Laitinen TT, et al. Use of antibiotics and risk of type 2 diabetes, overweight and obesity: the cardiovascular risk in young Finns study and the national FINRISK study. 

. 2022 Nov 18;22(1):284. doi: 10.1186/s12902-022-01197-y.

European research examines antibiotic exposure and its potential impact on future type 2 diabetes risk.