DiabetesGLUCAL3NCT05098301
Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration
An observational study of Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2021to 1 Jul 2022
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 diabetic patients
Who may be able to join
- Person with Type 1 diabetes
- Treated by basal-bolus therapy with MDI or pump
- Patient with social security or beneficiary of medical coverage
- Patient using functional insulin therapy or starting and education course
- Patient able to read and understand the procedure, and able to express consent for study protocol
Who cannot join
- Patient abusing substances
- Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, patient having a psychological condition making him unable to follow and understand study protocol
Trial locations and contacts
1 site in 1 country.
About this study
A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm
- Conditions
- Diabetes
- Keywords
- Diabetes, Functional insulin therapy
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the performances of an insulin titration algorithm
to evaluate the performances of an insulin titration algorithm to calculate insulin therapy parameters at the same precision of an expert practitioner
Measured: day 1
Secondary outcomes (1)
measure time-in-range evolution adjustment of insulin therapy parameters
to measure time-in-range evolution before and after adjustment of insulin therapy parameters by practitioner
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start30 Nov 2021
- Primary completion1 Apr 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric RENARD, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098301
- Sponsor's protocol ID
- RECHMPL21_0562
- Acronym
- GLUCAL3
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration
- ClinicalTrials.gov ID
- NCT05098301
- Acronym / sponsor ID
- GLUCAL3 / RECHMPL21_0562
- Conditions
- Diabetes
- Keywords
- Diabetes, Functional insulin therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 28 Oct 2021 (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.
A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetic patients
Key inclusion criteria (5 listed)
- Person with Type 1 diabetes
- Treated by basal-bolus therapy with MDI or pump
- Patient with social security or beneficiary of medical coverage
- Patient using functional insulin therapy or starting and education course
- Patient able to read and understand the procedure, and able to express consent for study protocol
Key exclusion criteria (2 listed)
- Patient abusing substances
- Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, patient having a psychological condition making him unable to follow and understand study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the performances of an insulin titration algorithm
Time frame: day 1
to evaluate the performances of an insulin titration algorithm to calculate insulin therapy parameters at the same precision of an expert practitioner
1 secondary outcome
measure time-in-range evolution adjustment of insulin therapy parameters
Time frame: day 1
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 24 Oct 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric RENARD, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University Hospital, Montpellier 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 2 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 24 Oct 2022. 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?
evaluate the performances of an insulin titration algorithm (time frame: day 1). 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 24 Oct 2022.