Product Highlight
Condition targeted:
Hypertension
How it works:
Application supports the treatment of hypertension by modifying lifestyle habits through the acquisition of knowledge, practice, and habituation of behaviors.
Impact:
Change from baseline in systolic blood pressure at 12 weeks during the clinical trial was 2.4 mmHg lower in the app intervention group.
Product Overview
Medical condition:
Essential hypertension
Target patient population:
Patients with I-grade essential hypertension in their 40s and 50s with clinic systolic blood pressure in the 140 mmHg range and mild obesity (BMI 25-30)
What to expect:
Improve lifestyle habits to lower systolic blood pressure
Clinical Overview
Indications for use:
Adjunctive treatment of essential hypertension in adults
Outcomes:
In an RCT, statistically significant differences were observed in the change from baseline in 24-hour systolic blood pressure measured by free-acting blood pressure monitoring (ABPM) at 12 weeks after trial enrollment.
Directions:
Patients use the patient app several times a day. They record their home blood pressure and practice learning and behaviors according to the personalized guidance provided by the app. Physicians use the Physician App during the medical examination. Physicians view the patient’s daily activity record and home blood pressure.
Risks & warnings:
Use under standard medical care and follow-up based on hypertension treatment guidelines (e.g., implementation of necessary drug therapy). Use under the guidance of a physician.
Place in therapy:
Complementary to current therapy
Product Access
Product description:
CureApp HT supports lifestyle modifications in daily life. The patient application is used on a mobile device and the physician application is used on a PC device.
Prescription status:
A prescription from a physician is required.
Patient access:
Patients can download the application from the Apple Store or Google App Store. Patients can activate it by entering the prescription code issued by their physician.
Use of this product requires access to:
- internet or wifi
- a smartphone
Provider access:
Physicians can access CureApp HT’s Physician App during clinic visits to view blood pressure data, diaries, dietary records, and program progress that patients have entered into the app. The data displayed on the Physician App can be used to aid treatment. CureApp HT can also be accessed through its own product, APS (App Prescription Service), and confidentiality of personal information is ensured through two-step authentication.
Coverage options:
The application is covered by insurance. Patients pay 30% of the total expenditure.
Product availability:
CureApp HT is available in:
- Japan: PMDA cleared class II medical device
Unique Features.
CureApp HT is the first software application in Japan to obtain regulatory approval as a stand-alone DTx product for hypertension.
Clinical Trials
The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.
- Study Title: Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial– 2021
Study Design: Randomized Control Trial, IRB certified
Outcomes: Primary Research Finding/Outcome: At 12 weeks post-enrollment, the change from baseline in 24-hour systolic blood pressure measured by free-acting blood pressure monitoring (ABPM) was significantly greater in the intervention group using the product than in the control group, with a difference of -2.4 mmHg (95% CI, -4.5 to -0.3 mmHg) between the groups.