Copenhagen, Denmark – March 31, 2025 – Hedia, a Danish company developing digital therapies (DTx) to optimize diabetes management, announces the launch of a clinical study in France to evaluate the impact of its digital therapy DTx Hedia Diabetes Assistant (HDA) on suboptimal glycemic control in patients with type 1 diabetes.

A Clinical Study to Demonstrate the Efficacy of HDA

The TEMPO clinical study, which has just been launched, is coordinated by Professor Louis Potier, diabetologist and endocrinologist at Bichat – Claude Bernard Hospital, AP-HP, and will include a total of 154 adults with type 1 diabetes and insufficient glycemic control.

This multicenter, randomized, and controlled clinical trial will evaluate the clinical benefits and safety of the HDA application in addition to standard treatment over a period of 26 weeks. The primary endpoint is to measure the improvement in time-in-range (TIR), a key indicator of glycemic control, as well as several secondary endpoints, including the monitoring of estimated glycated hemoglobin (HbA1c), quality of life, and patient satisfaction with their diabetes treatment.

“Improving glycemic control is a major challenge for people with type 1 diabetes. Thanks to the TEMPO study, we will be able to scientifically evaluate the impact of the HDA assistant on the daily management of the disease. This digital innovation could represent a significant advance in patient support,” explains Professor Louis Potier, principal investigator of the TEMPO study, Bichat – Claude Bernard Hospital, AP-HP.

As part of the launch of this clinical trial in France, Hedia will participate in the Congress of the French-Speaking Diabetes Society (SFD) which will be held from April 1 to 4, 2025 at the Palais des Congrès in Paris. She will also present the clinical design of her study via a poster entitled: “Evaluation of HDA, an insulin bolus calculator for optimizing time in glycemic range in people with type 1 diabetes in France.”

A Response to a Major Public Health Issue

Approximately two-thirds of people with type 1 diabetes have suboptimal glycemic control. This means that their blood sugar levels are not maintained stably within the recommended target range for a sufficient period, thus increasing the risk of acute and chronic complications (severe hypoglycemia, fatigue, concentration disorders, cardiovascular complications, neuropathies, kidney disease, and retinopathy).

Glycemic control is generally assessed using several indicators, including time-in-range (TIR), defined as the percentage of time blood sugar is between 3.9 and 10.0 mmol/L. A TIR of less than 60% is often considered suboptimal, as this means that more than 40% of the time, blood sugar is either too high or too low.

How to Improve Suboptimal Glycemic Control?

The HDA digital therapy is a CE IIb certified digital medical device designed to optimize diabetes management by facilitating:

• Insulin dose calculation,
• Consideration of patient habits (carbohydrate consumption, physical activity, and glucose levels).

“Our clinical studies have already shown that the use of Hedia Diabetes Assistant can reduce glycemic fluctuations and improve diabetes control, particularly with a decrease in eA1c (estimated glycated hemoglobin). We are convinced that our application can allow users to improve their time in target by at least 5%, a clinically significant change that can help reduce diabetes-related complications,” explains Lars Christian Lund, CEO of Hedia.

Preliminary studies have already shown that HDA can be used safely and has had a beneficial effect when used for 12 weeks.

A Simple and Intuitive Digital Therapy to Use

Hedia Diabetes Assistant is a digital therapy developed to help people with type 1 or 2 diabetes requiring insulin to better manage their disease. It features:

• An insulin bolus calculator: The application provides insulin dosage recommendations based on current glucose levels, recent carbohydrate intake, physical activity, and active insulin.
• An integrated food library: It has an integrated food library containing more than 1,500 foods, making it easier to count carbohydrates for accurate dietary management.
  
  • Search the library to find out the amount of carbohydrates in foods and drinks to calculate your insulin dose that is best suited to your meal.
• Physical activity consideration: Users can record their physical activities, taking into account the type and intensity of the exercise, which influences insulin dosage recommendations.
• A logbook: The application offers a logbook to track glucose levels, insulin doses, carbohydrate intake, and physical activity recorded on the application, allowing a clear visualization of glycemic trends.

State Visit of Denmark to France from March 31 to April 2, 2025

A European Partnership for a Resilient Future

From March 31 to April 2, 2025, Denmark and France will meet to explore new opportunities to cooperate, innovate and exchange knowledge in the health sector. Under the leadership of Their Majesties the King and Queen of Denmark, Hedia is honored to participate in this state visit which will bring together Danish and French stakeholders to highlight strategic European solutions in several sectors, including health.

About Hedia

Founded in Denmark, Hedia is a Danish company developing digital therapies (DTx) to optimize diabetes management. Its Hedia Diabetes Assistant (HDA) application is a Class IIb medical device that generates personalized recommendations for insulin therapy. Thanks to its innovations and strategic partnerships, Hedia is committed to developing advanced digital solutions to optimize diabetes management and improve patients’ quality of life.

Press Contact: Florence Portejoie, FP2COM, fportejoie@fp2com.fr, +33 6 07 76 82 82