Focus of the Report: This Health Technology Assessment focuses on the use of prescription digital therapeutics (PDTs) for the management of type 1 diabetes mellitus (T1DM) in adults.
Technology Description: PDTs are a mobile technology that offers patients with diabetes mellitus (DM) the ability to monitor daily trends in blood glucose (BG) levels and make appropriate modifications to therapy to reduce the likelihood of exceeding or falling below the target glycemic range. In addition, PDTs offer the ability to share real-time clinically relevant data with health care providers (HCPs), allowing for immediate intervention.
Controversy: Achieving glycemic control may be challenging for patients with DM. When insulin is required to control BG levels, the options are either daily injections or use of an electronic pump and infusion set system. PDTs may offer the advantage of insulin titration based on real-time patient data compared with other diabetes management options; however, the effectiveness of PDTs relies on active engagement from both the patient and HCP, including continuous reporting of clinically relevant data by the patient and review and response to that data by the HCP.
What is the efficacy of treatment for T1DM, including PDTs, compared with conventional care (CC)?
Does evidence suggest differences in efficacy or safety among PDTs?
What safety issues are associated with PDTs?
Have definitive patient selection criteria been identified for PDTs?
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