The challenge
A reading captures a moment. Life keeps moving.
Glucose levels can change quickly in either direction. Understanding what may be coming could help people feel better prepared for hypoglycaemia and better manage hyperglycaemia.
Medical-device software
Helping anticipate hypoglycaemia and limit hyperglycaemia.
GlukoLife is developing software as a medical device (SaMD) that analyses glucose data to help anticipate hypoglycaemia and limit hyperglycaemia in people living with diabetes.
Software in development. Not approved or cleared by any regulatory authority and not available for clinical use.
Who we are developing for
Across life stages and forms of diabetes.
GlukoLife’s research and development considers distinct populations whose glucose patterns, risks, and daily realities may differ. Future intended-use populations remain subject to clinical evidence and regulatory review.
- PrediabetesPeople at increased risk of developing type 2 diabetes
- PregnancyPeople managing glucose or diabetes during pregnancy
- Type 1 diabetesChildren, adolescents, and adults
- Type 2 diabetesYoung people and adults
Our purpose
Move from reacting toward anticipating.
We are working toward a future where people living with diabetes can anticipate hypoglycaemia and limit hyperglycaemia—not simply react after glucose levels change.
Why action matters
A growing global challenge.
Diabetes is not one condition and the path forward is not one-size-fits-all. Prevention is possible for many cases of type 2 diabetes; type 1 diabetes requires lifelong care. Both demand better access, earlier action, and continued innovation.
adults aged 20–79 were living with diabetes worldwide in 2024.
adults are projected to be living with diabetes by 2050—a 45% increase.
of diabetes cases worldwide are type 2 diabetes.
people of all ages were living with diagnosed clinical type 1 diabetes in 2024.
Prevent where possible
Type 2 diabetes can often be prevented or delayed. The causes of rising type 1 diabetes incidence remain unclear.
Improve care at every stage
Timely diagnosis and sustained access to quality care help people manage diabetes and live longer, healthier lives.
Reduce the burden of complications
Maintaining glucose levels within an appropriate range can help delay or prevent serious complications affecting the heart, kidneys, nerves, eyes, and limbs.
Type 1 diabetes incidence is increasing in most countries studied; an estimated 503,000 new cases were diagnosed worldwide in 2024. Source: IDF Diabetes Atlas, 11th edition (2025)
What we are developing
Software focused on what may come next.
GlukoLife is developing software as a medical device intended to analyse glucose data and identify evolving patterns associated with hypoglycaemia and hyperglycaemia. The goal is to help anticipate lows and limit highs, while keeping people and their care teams at the centre of every decision.
Patent-pending technology
Observe
Use glucose data to build a clearer picture of change over time.
Anticipate
Anticipate patterns linked to hypoglycaemia and help limit hyperglycaemia.
Support
Develop information intended to complement—not replace—clinical judgment.
How it is intended to work
From glucose information to earlier context.
-
Connect
Bring together glucose measurements and their evolution over time.
-
Analyse
Examine evolving glucose patterns linked to hypoglycaemia and hyperglycaemia.
-
Contextualize
Work toward useful information to anticipate lows and limit highs.
Designed around daily life
Clarity for moments that matter.
Diabetes management already asks a great deal of people. GlukoLife’s ambition is to turn complex glucose information into clearer, more useful context—designed to support everyday life while following a careful medical-device development process.
- Clear by design Working toward information that can be understood quickly.
- Made for real life Considering the routines and realities of people living with diabetes.
- Developed responsibly Advancing through research and evaluation before clinical availability.
Designed around care
Built with the wider diabetes ecosystem in mind.
People living with diabetes
Clearer context designed around the realities of daily glucose management.
Care teams
Information intended to complement professional judgment, not replace it.
Researchers
A platform for investigating approaches to anticipate hypoglycaemia and limit hyperglycaemia.
Clinical partners
Collaboration opportunities for careful prospective evaluation.
Why GlukoLife?
Built from lived experience.
“I was diagnosed in 2015 with a rare and severe form of Type 1 diabetes called LADA. Two years later, my mother-in-law, Lorinda M., died from complications of the same disease. This project is dedicated to her.”
“I began GlukoLife to build what I needed and she did not have: technology focused on understanding what may come next: anticipating hypoglycaemia and helping limit hyperglycaemia, because both can have serious consequences.”
Laurent Roumieu Founder, President & CEO
Technology and progress
Building carefully, with the next milestone in view.
GlukoLife remains in development. Each step is intended to strengthen the technology and the evidence needed for future evaluation.
Technology readiness
From relevant to operational evaluation.
Integrated prototype demonstrated in a relevant environment.
Preparing for prospective evaluation in an operational setting.
Company foundations
Protection and early support.
Protection pursued for core aspects of GlukoLife’s technology.
CAD 60,000 in project support administered through CEIM and funded by Québec’s Ministry of Economy.
Planned U.S. regulatory engagement
From prototype evaluation toward a human clinical study.
Technology readiness levels and FDA review are separate frameworks. GlukoLife intends to seek FDA feedback as the study design and supporting evidence mature.
- 01FDA Pre-Submission
Request feedback through the Q-Submission Program on the proposed device, evidence plan, and clinical protocol.
- 02Study-risk determination
Clarify whether the proposed investigation is significant risk, nonsignificant risk, or exempt from IDE requirements.
- 03Clinical-study authorization
If significant risk, obtain FDA approval of an Investigational Device Exemption plus IRB approval. A nonsignificant-risk study generally proceeds under IRB oversight and abbreviated IDE requirements.
- 04Human clinical evaluation
Conduct the approved investigation under the applicable protocol, informed-consent, monitoring, and reporting requirements.
- 05Future market submission
Use the resulting evidence to support the appropriate FDA pathway, which may be 510(k), De Novo, or PMA depending on classification.
An FDA-assigned submission number identifies a file; it does not by itself authorize a clinical study. The applicable requirements will depend on FDA and IRB review. FDA: IDE approval process
Company history
-
Feb 2017
The project begins
Following the loss of his mother-in-law, Lorinda M., to complications of type 1 diabetes, Laurent Roumieu dedicated the project to her and began developing the idea behind GlukoLife.
-
2018
First hand-drawn concept
The initial GlukoLife experience and process were mapped by hand.
-
2019
First algorithm
The first version of the GlukoLife algorithm was developed.
-
2021
GlukoLife founded
Company incorporated in Québec, Canada.
-
2023
CEIM incubation support
Received CAD 60,000 in project support administered by the Centre d’entreprises et d’innovation de Montréal (CEIM) and funded by Québec’s Ministry of Economy, Innovation and Energy. The support contributed to functional prototype development and continued research.
-
Today
Prototype development and verification
Continued technical verification, prospective evaluation planning, and regulatory preparation. Further evaluation is required before clinical use.
Current focus
The work ahead.
- Technical verification
- Prospective evaluation planning
- Regulatory strategy
- Research and clinical partnerships
Questions
What to know today.
Is GlukoLife available for clinical use?
No. The software remains in development and has not been approved or cleared by a regulatory authority.
Does GlukoLife replace medical judgment?
No. It is being developed to provide useful information that may complement—not replace—the judgment of people and their healthcare professionals.
Which glucose devices will it support?
Compatibility has not yet been announced. Integration requirements will be defined as development and regulatory planning progress.
Can research or clinical organizations collaborate?
Yes. GlukoLife welcomes discussions with qualified research, clinical, and development partners.
Working together
Help shape the next stage.
We welcome conversations with academic laboratories, clinical researchers, diabetes specialists, and development partners committed to careful, evidence-led innovation.