Can digital health RPM achieve meaningful change with type 2 diabetics? New metastudy expresses doubt.

March 27, 2024 | by

A metastudy from the Peterson Health Technology Institute (PHTI) has reservations about the efficacy of digital diabetes management tools. Over $50 billion has been invested in the sector between development, investments, mergers, and acquisitions. Generally, the claim around digital management tools for diabetes to aid self-management and prevent poor outcomes, particularly for those at high risk, has been that they can 1) deliver meaningful and lasting clinical benefits in reduction of HbA1c (glycemic control) and 2) reduce long-term costs of poor control, benefiting patients. In the US, diabetes affects 11% of the population and is an expensive chronic condition. It also disproportionately affects people of color and those with lower income, especially as they age.

The systematic literature review of 1,100-plus studies was augmented by interviews with physicians, patients, digital health experts, along with companies. They included 120 clinical references from DarioHealth, Omada, and Virta. The PHTI grouped digital tools into three types of solutions for Type 2 diabetes in adults. All used standard glucometers, not continuous glucose monitors/CGM as well as apps to provide real time feedback to a virtual or actual coach or care team:

  1. Remote patient monitoring (glucometer plus feedback): Glooko
  2. Behavior/Lifestyle modification (glycemic feedback plus coaching features): DarioHealth, Omada Health, Perry Health, Teladoc (Livongo), Verily (Onduo), and Vida
  3. Nutritional ketosis (dietary guidance that restricts carbohydrates and monitors the patient’s glycemic and ketone levels): Virta Health

The findings did not meet their expectations in demonstrating “clear, substantial, and durable progress toward glycemic control in people with type 2 diabetes, resulting in a lower prevalence of uncontrolled type 2 diabetes across the population.”

  • They did not deliver clinically meaningful benefits compared to ‘usual care’. Only three out of 10 comparative HbA1C studies achieved a meaningful difference of 0.5 percentage points (Minimal Clinically Important Difference or MCID) in patients. Their range was 0.23 to 0.60 percentage points compared to usual care.  The nutritional ketosis program had greater benefits as long as patients maintained the rigorous requirements of the therapeutic regimen.
  • The average price impact of the solution exceeds the savings achieved from the clinical benefits. The PHTI analysis looked at commercial insurance, Medicare, and Medicaid over three years. Provider reimbursement and pricing exceed cost savings from avoided care.

So where is the worth? The PHTI study recommended that:

  • Payers use these solutions for the highest risk and diverse/underserved populations
  • Regularly analyzing outcomes and tie contracts to clinical performance
  • Focus on patients with higher starting HbA1c newly starting insulin
  • Payers could also recommend nutritional ketosis as the Virta program had greater benefits.
  • Solutions could also evolve to include GLP-1 drugs, CGMs, and nutritional ketosis.

PHTI study (free download of full report, four sections, and appendices). PHTI press release.

PHTI is also offering a free webinar on Thursday 28 March at 2pm US Eastern Time on assessing digital diabetes management tools–registration here.

Action This Day in US healthcare, coming to pharma, insurance, home care and innovation

February 1, 2017 | by

Action This Day, in Churchill’s words. Today’s news of President Trump meeting with the CEOs of US pharmaceutical companies– Novartis, Merck, Johnson & Johnson, Lilly, Celgene, and Amgen–along with the PhRMA association head, indicates the speed of change that this two-week old Administration intends in healthcare. Trump’s points to the Pharma Giants: drug prices need to be brought down, especially for Medicare and Medicaid patients, through competitive bidding not price-fixing; bringing home production to the US; and that there is ‘global freeloading’ on US drugs. This last is a bit vague, and the pricing part may stir some Standard Republican Resistance, but what Trump also came down firmly for is speeding up the drug approval process. In return, the execs asked for tax reform.

Notable here is this quote:  “I’ll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market,” Trump said. “That includes price-fixing by the biggest dog in the market, Medicare, which is what’s happening.” The Hill, Business Insider

Does this mean an open door and encouragement for healthcare technology?

Certainly many startups, early-stage companies, and Grizzled Pioneers are eagerly anticipating a more open healthcare business environment than the many dictates, restrictions and the constant changing of goalposts they have faced for the past eight years. The hope is an openness of the Powers That Be on the Federal side (CMS, HHS, FDA) to innovation, patient-centered care and a change away from hammering constantly on lowering cost through a multitude of controls and top-down diktats on what Healthcare Should Be.

This Editor has seen companies straining to hang in there, playing the niches, moderating their equity raises, merging, projecting profitability sometime in the future. Some have not made it. One is the pioneer telehealth company Viterion Corporation, which was quietly dissolved by its parent company in Japan for various reasons at end of last year. (Editor’s disclaimer: I was marketing director for the company.)

Already innovation is reaching long-neglected areas like home care. Home support for the aging population isn’t buzzy, analytic or sexy, but it’s ready for change. The Financial Times takes a look at this $40 bn US market, focusing on the Hometeam caregiving service presently in New York, New Jersey and Pennsylvania, which has over $43 million in investment after only three years (Crunchbase); Honor, which has over $65 million in funding, operating California and Texas. Their points of difference from traditional home care agencies involve models and technology. Hometeam employs carers who are full employees with benefits and an average of $15/hour pay, double that of the usual minimum wage paid to independent contractors. They equip carers with iPads to track what happens in the home, and to report daily to families. Honor has an algorithm to help it scale up from the 100 or so carers who are the ‘break point’ in matching carers with patient needs. In contrast, the UK is far behind in development. The article looks at Vida which uses a mix of carers and technology for its private pay clients. Now approved by the Care Quality Commission, Vida is already in talks with local councils across London and Brighton. But funding is thin: £400,000 of start-up funding and planning to raise £1 million. Tech start-ups try to fix ailing US elderly care sector. If paywalled, search on the title. Hat tip to Susanne Woodman

Action Next Days? Predictions have been all over the place since the election. Many have been overheated (and highly political), but others explain the complexities of undoing the past six years. A reminder: the PPACA did not go into effect until 2010 and most of the provisions kicked in during 2011. Health tech law firm Epstein Becker Green trotted out its crystal ball (more…)