Diabetes Mellitus, Type 1DIABLONCT04081883
Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump
A study testing Biosensor algorithm in people with Diabetes Mellitus, Type 1, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Biosensor algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2023to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Patient with type 1 diabetes (T1D)
- Patient being equipped and trained with an external or internan insulin pump linked to a CGM
- Affiliated person or beneficiary of a social security scheme
- Free, informed and written consent
Who cannot join
- Patient under 18 years
- Patient not having T2D
- Pregnant or lactating patient
- No consent signed by the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.
In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.
Read the detailed description
Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. Type 1 diabetes (T1D) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). T1D is a serious, currently chronic and costly disease in children or young adults. Indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Biosensor algorithm
- Keywords
- Continuous Glucose Monitoring, Biosensor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosensor algorithmOther
The biosensor DIABLO responses will be compared to the measurements of standard CGMS, using blood glucose measures every 10 minutes by taking interstitial fluid from Diabetes Type 1 (DT1) patients with an internal or external insulin pump.
| Study group | Role | What they receive |
|---|---|---|
| Biosensor algorithm | Experimental | The biosensor DIABLO algorithm is compared to Continuous Glucose Monitoring Systems (CGMS) utilisation. Receives: Other: Biosensor algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between biosensor to CGMS responses
Measure blood glucose every 10 minutes by taking interstitial fluid from DT1 patients with an internal or external insulin pump to compare the biosensor responses to measurements of standard CGM systems.
Measured: 2 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start27 Jan 2023
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogdan CATARGI, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081883
- Sponsor's protocol ID
- CHUBX 2018/48
- Other IDs
- 2019-A01837-50
- Acronym
- DIABLO
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.
- ClinicalTrials.gov ID
- NCT04081883
- Acronym / sponsor ID
- DIABLO / CHUBX 2018/48
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Continuous Glucose Monitoring, Biosensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.
Detailed description
Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. Type 1 diabetes (T1D) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). T1D is a serious, currently chronic and costly disease in children or young adults. Indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biosensor algorithm | Experimental | Other: Biosensor algorithmThe biosensor DIABLO algorithm is compared to Continuous Glucose Monitoring Systems (CGMS) utilisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years of age
- Patient with type 1 diabetes (T1D)
- Patient being equipped and trained with an external or internan insulin pump linked to a CGM
- Affiliated person or beneficiary of a social security scheme
- Free, informed and written consent
Key exclusion criteria (4 listed)
- Patient under 18 years
- Patient not having T2D
- Pregnant or lactating patient
- No consent signed by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosensor algorithmThe biosensor DIABLO responses will be compared to the measurements of standard CGMS, using blood glucose measures every 10 minutes by taking interstitial fluid from Diabetes Type 1 (DT1) patients with an internal or external insulin pump. | Other | Biosensor algorithm |
Primary outcome
Comparison between biosensor to CGMS responses
Time frame: 2 days after inclusion
Measure blood glucose every 10 minutes by taking interstitial fluid from DT1 patients with an internal or external insulin pump to compare the biosensor responses to measurements of standard CGM systems.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan CATARGI, Pr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biosensor algorithm in people with Diabetes Mellitus, Type 1, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between biosensor to CGMS responses (time frame: 2 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.