Diabeloop: Launch of a Multi-Country Clinical Study in Adolescents and Young Adults With T1D


Unannounced Meal Management Efficacy Key to a Better Quality of Life for People with Diabetes

At the International Conference on Advanced Technologies & Treatments for Diabetes, Diabeloop, a leader in Automated Insulin Delivery technology, announces the launch of a clinical study in adolescents and young adults with T1D, in France, Belgium and Germany. The main objective is the validation of its hybrid closed-loop system that doesn't require meal declarations, a major step towards fully automated solutions.

Major impact on quality of life expected

The open-label, multicenter, randomized, cross-over, four-week outpatient study1 will assess, in real-life conditions, the efficacy of Diabeloop's integrated solution, embarking an Unannounced Meal Management module.

The Automated Insulin Delivery system will also integrate Terumo Corporation's MEDISAFE WITH patch pump, for the first time since the companies announced extended development and commercial agreements a little over a year ago. 

The wearable, lightweight patch pump will optimize comfort for the 50 adolescents and young adults with T1D, aged from 12 to 18 years old, enrolled in this study. 

Three reference hospitals in France, Belgium and Germany are involved in the trial, whose inclusion phase should be completed by the end of March: 

  • Necker-Enfants Malades Hospital, Paris, France, Department of Endocrinology, Diabetes and Nutrition led by Prof. Jacques Beltrand, Principal Investigator of the study
  • Catholic University, Leuven, Belgium, Pediatric Endocrinology Unit, Prof. Kristina Casteels
  • Kinder-und Jugendkrankenhaus, Hannover, Germany, Diabetes Center for Children and Adolescents Auf Der Bult, of Prof. Thomas Danne

"The Diabetes Center AUF DER BULT treats close to 800 youth with type 1 diabetes. Devices for diabetes technology are now a standard at our center. Nevertheless, for many adolescents, it remains a burden to enter carb counts even during automated insulin therapy. We are eager to study new approaches to reduce this burden in our clinical research center like this international collaborative study in adolescents and young adults," declares Prof. Thomas Danne

An answer to patients' needs, driven by scientific observations 

More than a mission, patient knowledge is intrinsic to Diabeloop. Therefore, the company understands the increased complexity of insulin management during adolescence; families constantly report difficulties at school and the influence of the social environment on disease acceptance, for example. 

Together with their partner CEA-Leti, Diabeloop confirmed and refined the understanding of the unmet need with a workshop: people with diabetes shared their experience of managing diabetes during their teenage years. The burden of diabetes management and the impact of forgetting to bolus were some of the main concerns shared by the participants. 

Those experiences very much support the scientific conclusions that led Diabeloop to develop the project of the study, focused on meal management, for 12- to 18-year-old patients.

A study2 indeed showed that only 17% of young patients achieved the HbA1c goal of <7.5%. Another studylooked at the effect of missed meal boluses, concluding that "four missed meal boluses per week can result in a 1% increase in HbA1c" while observing that "it is likely that many missed boluses occur in social settings". 

While beneficial to all, a fully closed-loop with Unannounced Meal functionality would have a major impact on quality of life for the younger population, who are also prone to be early adopters of new technologies and patch pumps. 

Unannounced Meal Management: more automation, more personalization 

The Unannounced Meal Management (UMM) module is directly embedded in Diabeloop's self-learning algorithm. 

The UMM feature is automatically activated when the algorithm detects a significant blood glucose rise, associated with a high probability that a meal triggered this spike in glucose levels. 

UMM enables patients to not declare a meal. Diabeloop's algorithm will detect an unexpected high and correct it by adjusting insulin doses. Combined with its unique auto-learning capacities - optimizing, among others, the meal ratio incrementally - this innovation contributes to feeding Diabeloop's holistic approach, considering the singularities and the personal needs of every individual.

Erik Huneker, CEO and co-founder of Diabeloop, comments: "Every person with diabetes is unique and deserves solutions that will adapt to his or her physiology and lifestyle. That's why a high level of personalization truly matters. There is still some way towards true fully closed-loop solutions but the integration of the UMM module would be a very significant milestone. The efficacy of the UMM will be firstly assessed in adolescents and young adults with diabetes, who profoundly need this major improvement, but it will be generalized and implemented in all of Diabeloop's AID solutions in the near future". 

The development of the Unannounced Meal Management (UMM) and the design of the clinical study for T1D adolescents and young adults have been supported by funding from EIT Health and the consortium members.4


About Diabeloop

Diabeloop's mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.

Created in 2015, Diabeloop offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop's first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.

Diabeloop completed its Series C financing round in June 2022, securing 70 million euros to accelerate its commercial roll-out and support its sustained growth strategy and its high-impact projects.

Today, Diabeloop gathers the personality, passion, and skills of talented individuals who work hard to improve the quality of life for every person living with diabetes.



1 NCT04725591

2 Miller KM Diabetes Care 2015;38:971-978 
"The American Diabetes Association (ADA) HbA1c goal of <7.5% for youth was achieved by only 17% and the goal of<7,0%  for adults by only 21%" from [Foster et al. Diabetes Technology & Therapeutics, 2019]

3 Pediatr Diabetes. 2010 Nov; 11(7): 498-504. Comeaux SJ, Jaser SS. Autonomy and insulin in adolescents with type 1 diabetes.

4 CEA-Leti, CERITD, RI.SE, Profil, KU LEUVEN. 

Contact Information:
Stéphanie JÉGU
Global Brand & Communication Director, Diabeloop
[email protected]

Original Source: Diabeloop: Launch of a Multi-Country Clinical Study in Adolescents and Young Adults With T1D

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New Study Shows Copper-Silver Ionization is Effective for Legionella Control

Legionnaires' disease cases have increased nearly tenfold in recent decades, leading to thousands of hospitalizations and deaths. Outbreaks are linked to Legionella, a bacteria found in potable water systems in large facilities like hospitals, multi-family buildings, resorts, and office buildings. A recently published study shows that copper-silver ionization effectively controls Legionella in building water systems to prevent Legionnaires' disease.

New Study Shows Copper-Silver Ionization is Effective for Legionella Control
Copper-Silver Ionization System

A copper-silver ionization system installed in a building to prevent Legionella in the potable water supply.

A new study published in the American Water Works Association (AWWA) Water Science journal shows that copper-silver ionization effectively controls Legionella in building water systems. The study, conducted by Dr. Mark LeChevallier with technical and financial support from LiquiTech, examines more than 80 sources of research studies and related literature to analyze the efficacy of copper-silver ionization as a water treatment solution. Dr. LeChevallier concludes "that use of copper-silver ionization to control Legionella and other opportunistic pathogens is highly effective when the units are properly designed, maintained, and operated."

Legionnaires' disease cases have increased nearly tenfold in recent decades, leading to thousands of hospitalizations. Those who catch Legionnaires' disease experience a severe form of pneumonia caused by Legionella, a bacteria found in poorly maintained water systems.

Studies show that Legionella is responsible for about two-thirds of all disease outbreaks from drinking water and the cause of all documented deaths attributed to drinking water-associated infections.

Historically, outbreaks were linked to cooling tower systems. As our understanding of Legionella has advanced over recent decades, most outbreaks are now connected to potable water systems in large facilities, such as hospitals, long-term healthcare facilities, resorts, and office buildings. It's estimated that 54% of all potable building water systems have some level of Legionella present.

Plumbing codes and regulations have been developed to standardize the design, structure, and management of building water systems to prevent waterborne diseases. However, based on the studies cited in this article and elsewhere, there is a need for supplemental treatment of building water systems.

One such supplemental treatment is copper-silver ionization, a chemical-free disinfection solution for potable water systems. It releases copper and silver ions into the building's water system to destroy waterborne pathogens like Legionella

Copper-silver ionization is not a new water treatment option. Silver ionization was used in the 1960s by NASA for the sanitation of water on spacecraft. In the 1980s, copper-silver ionization was used in swimming pools as an alternative to chlorine.

Later, in 1994, copper-silver ionization was the first reported effective treatment for controlling Legionella in a hospital. Today, copper-silver ionization is used to prevent waterborne pathogens in a variety of buildings with complex water systems.

Although copper-silver ionization is a low-cost and chemical-free option for water disinfection, the system must be designed properly and used in the appropriate applications to achieve optimal results. Crucial to its effectiveness is identifying and responding to abnormalities in water usage patterns and chemistry. 

Dr. LeChevallier, a drinking water research scientist with a Ph.D. in Microbiology, examined literature and studies related to copper-silver ionization system design, maintenance, and operations, and the impact water chemistry has on its performance. In addition to authoring more than 300 research papers, Dr. LeChevallier is a member of the Drinking Water Subcommittee of the Science Advisory Board of the United States Environmental Protection Agency (US EPA), a past member of the Water Science Technology Board of the National Academies of Science, and the past Chair of the AWWA Water Science & Research Division.

In his recently published study, Dr. LeChevallier explained, "These water quality and operational characteristics must be properly addressed to assure that the highest disinfection efficacy is obtained through copper-silver ionization."

He reviewed research and related literature to investigate the mechanisms of copper and silver disinfection. Copper-silver ionization works by treating water through electrolysis. An electric current is applied to a copper and silver bar to produce and release positively charged ions. These copper and silver ions then find microorganisms in the water with a negative charge, like Legionella. The copper ions bond to the negative walls of the microorganisms, disrupting cell wall permeability and the absorption of life-sustaining nutrients. This disruption to the cell wall allows the silver ions to enter and destroy the core of the bacteria, thus making it impossible to survive. 

Dr. LeChevallier cited studies showing that copper and silver can work as biocides independently or together. One study emphasized that combined treatment with copper and silver was associated with decreased incidence of Legionella and a faster reduction of bacteria than copper or silver alone.  

In addition to copper-silver ionization being considered an effective supplemental method for water treatment by researchers, the US EPA has recognized both copper and silver as metallic antimicrobial agents. Studies show that copper-silver ionization is effective against many waterborne pathogens, including Legionella, Nontuberculous Mycobacterium, Pseudomonas, Stenotrophomonas, Acinetobacter, and fungi.

While the issue of copper-silver resistance was discussed in portions of the literature that Dr. LeChevallier reviewed, it's important to note that there was no evidence of it occurring with Legionella. Copper-silver resistance, where pathogens can continue to grow and thrive even in the presence of copper and silver, was only observed with E. coli and Salmonella.

During his investigation, Dr. LeChevallier found that the design, operation, and maintenance of copper-silver ionization systems are critical to their effective functionality. In his published paper, he explained that copper-silver ionization will act as a water disinfectant; however, the proper engineering and operation of the system are integral to its success.

Essential components of the copper-silver ionization system include the electrodes, flow cells, power supply, control panel, flow meter, and web interface. Each component must be operated and maintained for copper-silver ionization to be most effective. 

"Buyers of [copper-silver ionization] systems should pay attention to the design and configuration of the electrodes - particularly as they wear. The construction of the flow cell and the adequacy of the power supply are important to deliver the necessary amperage to achieve the target copper and silver concentrations. Copper and silver doses should be flow paced and can be remotely monitored with a web-based interface," said Dr. LeChevallier.

Additionally, Dr. LeChevallier cautioned that water quality can impact copper-silver ionization as a water treatment. He explained that water chemistry, physiochemical, and environmental factors can influence the efficacy of copper-silver ionization if not considered and managed correctly. 

Specific factors to consider include temperature, oxygen levels in the water, flow, pH levels, and levels of biofilm, sediment, and other chemicals that can impact the performance of copper-silver ionization. He stressed that these factors must be considered during planning, commissioning, and system operations for copper-silver ionization to be successful. 

Dr. LeChevallier cited several case studies where copper-silver ionization was implemented in a building water system with positive outcomes. He explained that University of Pittsburgh researchers Dr. Stout and Dr. Yu found that copper-silver ionization is a viable proactive strategy for long-term Legionella control, specifically for healthcare facilities. 

The studies collected data from 16 hospitals with copper-silver ionization systems over the course of five to 11 years. These studies found that 50% of the hospitals had not reported any indications of Legionella, and 43% had no indications for another five years.

In addition to the promising implementation of copper-silver ionization at hospitals, other case studies found benefits in multi-family buildings, hotels, and other specialized hospitals, including children's and veterans' hospitals.

Summarizing his findings, Dr. LeChevallier concluded, "This study has shown that [copper-silver ionization] can be effectively used for management of Legionella and other waterborne pathogens through the installation of a properly designed and maintained [copper-silver ionization] system and the details of the engineering and operation of the system are important to ensure the consistent delivery of copper and silver ions at their target levels."

About LiquiTech

For more than 30 years, LiquiTech has partnered with businesses worldwide to provide chemical-free, sustainable water treatment solutions. Their highly engineered approach brings together the right combination of products, services, and expertise to solve the most challenging water quality issues and help businesses get the most out of their water-bearing equipment. With more than 3,000 installations, LiquiTech is the worldwide leader in smart, clean solutions for water treatment. Learn more at liquitech.com.

Contact Information:
Kelsey Raftery
Director of Marketing
[email protected]

Original Source: New Study Shows Copper-Silver Ionization is Effective for Legionella Control

Let’s Talk Interactive, Inc. Ranks 50th in Financial Times’ The Americas’ Fastest-Growing Companies in 2023

An innovator in virtual care, LTI is one of the fastest-growing companies in the Americas with a 1,256 percent growth rate between 2018 and 2021.

Let's Talk Interactive, Inc. (LTI), a leader in customizable virtual care solutions, is ranked number 50 in the Financial Times' fourth edition of The Americas' Fastest-Growing Companies, a ranking and special report on high-growth businesses in North, Central, and South America, based on companies with the strongest revenue growth between 2018 and 2021.

"It's an honor for Let's Talk Interactive, Inc. to be named among the Financial Times' fastest-growing companies," CEO and Founder Art Cooksey said. "This comes on the heels of being recognized by Inc magazine as well, reinforcing our standing as a company that has a high growth potential."

For this special report, the Financial Times examined over 7,000 public companies across 20 countries. The data was collected via desk research in official sources like publicly available earning presentations, investor relations, websites, and annual reports.

"We continue to innovate in the virtual care sector, one that has experienced challenges and consolidation recently," Cooksey said. LTI offers healthcare providers a HIPAA-compliant telehealth platform and medical device integrations that increase patient access to quality healthcare.

LTI's new enterprise telehealth platform, TrustVideo, is customizable with any workflow, can integrate with any EMR/EHR, and serves any medical use case. LTI's Medcart software pairs with medical hardware such as telemedicine carts, soft packs, and peripherals, which are all part of LTI's overall custom digital healthcare solutions that enable providers to evaluate patients remotely.

"We are continuing global growth with our partners, AWS, Ingram Micro, Liberty Wesco, and continue to focus on our mission to expand access to healthcare," Cooksey said. "We are experiencing tremendous growth and look forward to continuing to provide excellent telemedicine solutions to our customers."

As a leader in creating innovative digital healthcare solutions, the company's award-winning HIPAA-compliant software is enhanced with custom web and software development as well as provider network solutions that improve access to care at any time, from anywhere in the world.

About Let's Talk Interactive, Inc.

Let's Talk Interactive, Inc. is an innovator in telehealth that has developed the most complete and configurable HIPAA-compliant telemedicine platform in the world. Through proprietary telehealth software, medical hardware, and provider network solutions, LTI gives those in need instant access to care. Headquartered in Charlotte, NC, the company ranked No. 496 on the 2022 Inc. 5000 annual list of fastest-growing companies. LTI is committed to providing innovative solutions for patients and healthcare providers in the post-COVID-19 era. For more information about Let's Talk Interactive, visit www.letstalkinteractive.com.

Contact Information:
Caitlin Wolf
PR and Communications Executive, LTI
[email protected]

Original Source: Let's Talk Interactive, Inc. Ranks 50th in Financial Times' The Americas' Fastest-Growing Companies in 2023