Diabetes management tools not worth the cost, study finds. But digital health companies push back on 'flawed' analysis

A new analysis pours cold water on the effectiveness of widely used digital diabetes management solutions, stirring up discussion about how best to evaluate the growing market of digital health tools.

The blistering report, released by the Peterson Health Technology Institute (PHTI), concluded that diabetes monitoring apps "do not deliver meaningful clinical benefits, and result in increased healthcare spending." 

“When these digital diabetes management tools launched more than a decade ago, they promised to improve health outcomes for people with diabetes and deliver savings to payers. Based on the scientific evidence, these solutions have fallen short, and it is time to move toward the next generation of innovation,” said Caroline Pearson, executive director of the PHTI, in a statement accompanying the report, which was released last week.

It's the organization's first analysis since launching in July as an independent evaluator of digital health technologies. The Peterson Center on Healthcare launched the PHTI, with a commitment of $50 million, to assess the clinical benefits and economic impact of digital health solutions along with the offerings' effects on health equity, privacy and security. 

The independent organization says it aims to provide independent, evidence-based assessments of emerging products, something that is currently lacking in the market.

The analysis evaluated eight widely used digital health tools that support people with Type 2 diabetes from DarioHealth, Glooko, Omada, Perry Health, Teladoc (Livongo), Verily (Onduo), Vida Health and Virta Health. 

If health plans or employers are going to be paying extra for these solutions, they have to deliver extra benefit clinically above and beyond what a patient would expect in 'usual care'." —Caroline Pearson, executive director of the PHTI, said in an interview.

The PHTI said its analysis was conducted by a team of health technology assessment experts and informed by clinical advisers. The organization tapped health economics firm Curta and economics consulting company Charm Economics as evaluation partners on the research along with the Institute for Clinical and Economic Review (ICER), which co-developed the ICER-PHTI Assessment Framework for Digital Health Technologies.

The study focused on reductions in HbA1c as the standard form of measurement of glycemic control in diabetics. The analysis concluded that people who use these tools "achieve only small reductions in hemoglobin A1c (HbA1c) compared to those who do not, and these reductions are not sufficient or sustained enough to change the trajectory of their health, care, or long-term prognosis, including cardiovascular risks," the report said.

Pearson said the PHTI's analysis assessed whether digital diabetes solutions improve users' health outcomes over "usual care."

"If health plans or employers are going to be paying extra for these solutions, they have to deliver extra benefit clinically above and beyond what a patient would expect in 'usual care,'" she said.

The industry needs to set a higher standard for digital health tools, Pearson contends. "The digital health industry is maturing and as it matures, it's very important that we raise the bar on expectations and evidence. That’s what we’re trying to do," Pearson told Fierce Healthcare.

The PHTI wants to drive more discussion on evidence-based research for digital health, Pearson noted. 

As stakeholders unpacked the findings, the report quickly sparked conversations on social media. "Why do we ask service interventions to deliver better outcomes at less cost while we are okay paying premium money for medications that often deliver mild to moderately better outcomes than the prior care. This conundrum has stifled service innovation in health care," wrote Rami Bailony, M.D., founder and CEO of Enara Health, on X (formerly Twitter).

Many digital health stakeholders agreed that there needs to be a more rigorous assessment of solutions but questioned PHTI's approach to the evaluation, specifically its narrow focus on changes in A1c levels.

"It's a missed opportunity to have an informed, unbiased evaluation of the landscape. Instead, it was really imprecise and not rigorous, and for many reasons, among them, not including the right experts, not including the right studies, not adhering to the framework that was originally published and having a very narrow view of outcomes," Omar Manejwala, M.D., chief medical officer at DarioHealth, said in an interview.

The Digital Therapeutics Alliance, which includes DarioHealth as one of its members, said in a statement that it supports the PHTI's "overarching methodology" but disagrees with the conclusions drawn.

DTx noted the lack of endocrinologists among the clinical advisers who contributed and reviewed the report, and the trade group argued the report made a "sweeping conclusion" on all diabetes products based on a small sample size.

Manejwala also took issue with the PHTI issuing a patient guide (PDF) for digital diabetes solutions based on what he called a "flawed analysis."

The report highlighted one "promising solution" out of the eight that were evaluated—Virta Health's. The company's solution aims to reverse Type 2 diabetes through personalized nutrition therapy and remote medical care.

Initial data showed Virta users are much more likely to achieve clinically meaningful benefits in glycemic control, including diabetes remission and the ability to reduce or eliminate their diabetes medications, if they can maintain the rigorous dietary requirements of the intervention, the PHTI report concluded.

"The real question here is for how many patients is nutritional ketosis a real possibility in terms of being able to adhere to that program?" Pearson said.

"We're pleased that the report validated the work that we do everyday with patients to help them reverse their diabetes, pre-diabetes and obesity," Virta Chief Medical Officer Adam Wolfberg, M.D., said in an interview. "We're also pleased that it validated the results of the research we did many years ago that established our approach to diabetes reversal is demonstrably effective."

Unpacking the PHTI study

In the U.S., about 1 in 7 adults—more than 38 million—has Type 2 diabetes, which is the eighth leading cause of death. At over $400 billion of total healthcare spending annually, diabetes is the most expensive chronic condition to treat and manage.

Given the critical role of patient self-management, investment in digital health tools has surged in recent years. The PHTI pegs investment into the category, including mergers and acquisitions, at more than $58 billion, according to the report.

The PHTI's analysis had two main components—clinical effectiveness and economic impact.

On the clinical side, researchers focused primarily on glycemic control as well as secondary health outcomes such as cardiovascular risk factors, body weight, patient-reported outcomes and use of medication.

The PHTI’s analysis incorporated an evidence-based assessment framework and review of more than 1,100 articles, including more than 100 submitted by companies evaluated in the report. Three companies—DarioHealth, Omada and Virta—submitted a combined 120 clinical references. Of these, 69 articles were analyzed for findings on the primary outcome of glycemic control, according to the report.

The studies show that these digital tools deliver small reductions in HbA1c of 0.23 to 0.60 percentage points compared to usual care, according to the report findings.

"We did not conduct any original claims analysis. This is really a review of existing scientific literature on the clinical side. We also worked directly with the companies and they each had an opportunity to submit additional data evidence to support our process," Pearson said in an interview.

The PHTI’s analysis also did not find evidence to demonstrate that digital diabetes management tools improve other health factors, and it concluded that these tools are not currently being deployed in ways that improve health equity.

The organization's economic analysis modeled expected healthcare savings resulting from improved glycemic control for patients using digital diabetes management solutions who are enrolled in Medicare, Medicaid and commercial insurance.  

The PHTI concluded digital diabetes management solutions actually increase net healthcare spending.

For patients using tools in the remote patient monitoring category, annual spending is projected to increase by $2,002 for commercial insurance patients, by $1,011 for Medicare patients and by $723 for Medicaid patients as a result of higher provider payments, the report said. For patients using tools in the behavior and lifestyle modification category, annual spending is estimated to increase by $484 for commercial insurance patients, by $513 for Medicare patients and by $574 for Medicaid patients

“Patients with diabetes invest time, energy and resources in these tools, and they deserve to experience meaningful, positive benefits for their health. The healthcare sector as a whole needs transparent, accurate information about the clinical and economic impact of these digital tools that are taking up precious healthcare dollars," Pearson said.

The PHTI said one bright spot for digital diabetes tools is the potential to help patients with higher starting HbA1c levels who are newly starting insulin. "By engaging these patients at an early critical transition point in their care, digital solutions could have more impact by helping establish good self-management habits among these higher-risk patients," the report said.

The report also offers recommendations and best practices for vendors, providers and payers.

The next generation of diabetes management solutions should aim for clinically meaningful improvements in glycemic control, the PHTI wrote, including integrating continuous glucose monitors and new GLP-1 obesity medications. Solutions should also generate sufficient evidence to support broader adoption, and they should prioritize access for populations who need them most.

Payers, including health plans and employers, should adapt their contracting approach to require transparency about the solutions' usage and benefits within their covered populations, the report said. Purchasers of these solutions also should include financial performance guarantees tied to clinical outcomes. 

Digital health industry pushes back on PHTI's assessment

Many digital health executives questioned how the PHTI used the data companies submitted and the evaluation's exclusion of real-world data. Some executives said, off the record, they were "blindsided" by how the PHTI went about its evaluation.

The Digital Therapeutics Alliance (DTx) criticized the PHTI's reliance on predictive models rather than actual cost savings studies for its evaluation. "Comparative studies using actual healthcare resource utilization (HCRU) data are generally considered more rigorous than the budget impact models using putative cost models," the trade group wrote.

"These types of comparative studies based on actual utilization reduction are preferred by health plans and other payers over predictive models. It is concerning that PHTI intentionally excluded published real-world economic studies in favor of lower-performing predictive figures," DTx wrote.

Wolfberg with Virta said the PHTI's focus on clinical outcomes was the right approach. "The thesis that you shouldn't look at glucose and look at the claims analysis is taking your eye off the ball," he noted.

The PHTI analysis narrowly focused on one disease outcome in one disease state, noted Carolyn Bradner Jasik, M.D., chief medical officer at Omada Health.

"For organizations like ours that serve people across many different conditions, at different acuity levels, it doesn't really provide a comprehensive look at the service offerings," Jasik said. "For future reporting, we really encourage PHTI to look more broadly at a myriad of core clinical outcomes for which programs like ours are designed."

Only 30% of Omada members come into the program with an elevated A1c level, she noted. "Seventy percent of members come in with a stable A1c and they're working with us on a myriad of other goals and objectives" such as weight loss, controlling hypertension and medication adherence.

Sarah Linke, Ph.D., Omada Health’s senior director of health economics and outcomes research, points to a newly published study, which was not included PHTI's analysis, that demonstrates that patients with elevated baseline A1c enrolled in Omada's digital diabetes self-management program experienced clinically meaningful and statistically significant reductions in A1c.

"The PHTI report gets some things right—diabetes is a huge problem in this country, and we spend way too much dealing with the downstream effects of the disease. As the report states, until we find an outright cure, the most effective treatment is ‘substantial, and durable progress toward glycemic control'," a Vida Health spokesperson said via email.

Vida says its diabetes programs are clinically proven to do just that, as reflected in its body of peer-reviewed publications and the satisfaction of the "tens of thousands of members" who have found success with its diabetes program.

A Teladoc Health spokesperson said the company's data show its diabetes management program improves weight, blood pressure and medication adherence. "For uncontrolled members in our diabetes management programs (starting at A1c>=9), our program delivers meaningful results and sustains those health improvements over time. 2.9% A1C reduction at three months sustained over five years," the spokesperson said via email.

The virtual care company, which acquired Livongo in 2020, also contends that its chronic condition program averages 3.4x ROI and $180 per participant per month, with its ROI estimation independently reviewed and validated by Milliman.

A spokesperson for Perry Health, another solution included in the evaluation, said the company has seen an average decrease of 2.9% in members with an initial A1c ≥ 9%, a reduction much greater than what was reported in the PHTI analysis.

"At Perry Health, we work primarily with underserved populations who face significant barriers in accessing quality healthcare—90% of our members lack an endocrinologist, and 30% do not have a primary care provider (PCP). Our comprehensive care model addresses these critical gaps by providing not just medical support but also mental health and social determinants of health (SDOH) interventions," the spokesperson said, also noting that the company's remote care approach has led to "substantial improvements in medication adherence and overall compliance with care plans," and "notable changes in weight, patient satisfaction, and healthcare literacy."

In the coming months, PHTI plans to evaluate digital solutions for virtual musculoskeletal care followed by hypertension and then tools for mental health conditions including depression and anxiety.

"Digital hypertension management will be a really interesting area compared to diabetes," Pearson noted.

PHTI is hosting a webinar Thursday, March 28, to share key insights from the digital diabetes management solutions report.