Type I DiabetesEGHYANCT05151770
Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
An observational study of Type I Diabetes, run by M-DT1 at 2 sites in France.
Trial summary
The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Measure of glycemia levels and comparison to algorithm predictions
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Dec 2021to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type I diabetes
Who may be able to join
- Type 1 diabetes
- ≥ 18 years old
- Hb1Ac<12%
Who cannot join
- Patient without continuous glucose monitoring system
- Disease other than diabetes (bulimia, anorexia…)
- Dialysis patient
- Known history of drug or alcohol abuse
- Patient under judicial protection
- Person deprived of liberty
Show all 10Show fewer
- Pregnant, parturient or breastfeeding woman
- Patient in psychiatric care
- Patient admitted to a health or social institution for purposes other than research
- Any reasons that might interfere with the evaluation of the study objectives
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.
- Conditions
- Type I Diabetes
- Being tested
- Measure of glycemia levels and comparison to algorithm predictions
- Keywords
- Type I diabetes, Hyperglycemia, Post prandial glycemia, algorithm
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of glycemia levels and comparison to algorithm predictionsOther
The study aims to evaluate the efficacy of a new algorithm in predicting the evolution of glycemia levels after a full meal. Glycemia levels measured during and after a full meal will be compared to the values predicted by the algorithm. Composition of the meals will also be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm efficacy
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements.
Measured: 15 days
Secondary outcomes (5)
Algorithm efficacy (lower margin of error)
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements (the accepted margin of error is reduced by 25 to 50% when compared with primary outcome).
Measured: 15 days
Algorithm efficacy versus meal composition
Meals will be analyzed within different groups according to their respective nutritional index. For each group, algorithm prediction reliability will be determined.
Measured: 15 days
Influence of the age of the patients on algorithm results
The Algorithm efficacy will be analyzed according to the age of patients
Measured: 15 days
Influence of the BMI on algorithms results
Weight and height of patients will be combined to report BMI in kg/m2. Algorithm efficacy will be analyzed according to the BMI of patients
Measured: 15 days
Influence of the insulin administration on algorithm results
Data obtained from patients using insulin pumps will be compared to data obtained from patients using multiple daily insulin injections.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start30 Dec 2021
- Primary completion2 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M-DT1
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151770
- Sponsor's protocol ID
- 2021-MDT1-001
- Other IDs
- 2021-AO2599-32
- Acronym
- EGHYA
- Status last verified
- Apr 2022
- First submitted
- 12 Nov 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm
- ClinicalTrials.gov ID
- NCT05151770
- Acronym / sponsor ID
- EGHYA / 2021-MDT1-001
- Conditions
- Type I Diabetes
- Keywords
- Type I diabetes, Hyperglycemia, Post prandial glycemia, algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M-DT1Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Assistance Publique Hopitaux De Marseille
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 9 Dec 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.
The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type I diabetes
Key inclusion criteria (3 listed)
- Type 1 diabetes
- ≥ 18 years old
- Hb1Ac<12%
Key exclusion criteria (10 listed)
- Patient without continuous glucose monitoring system
- Disease other than diabetes (bulimia, anorexia…)
- Dialysis patient
- Known history of drug or alcohol abuse
- Patient under judicial protection
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 |
|---|---|---|
| Measure of glycemia levels and comparison to algorithm predictionsThe study aims to evaluate the efficacy of a new algorithm in predicting the evolution of glycemia levels after a full meal. Glycemia levels measured during and after a full meal will be compared to the values predicted by the algorithm. Composition of the meals will also be collected. | Other | – |
Primary outcome
Algorithm efficacy
Time frame: 15 days
The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements.
5 secondary outcomes
Algorithm efficacy (lower margin of error)
Time frame: 15 days
Algorithm efficacy versus meal composition
Time frame: 15 days
Influence of the age of the patients on algorithm results
Time frame: 15 days
Influence of the BMI on algorithms results
Time frame: 15 days
Influence of the insulin administration on algorithm results
Time frame: 15 days
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 15 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes, run by M-DT1 at 2 sites 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 3 inclusion and 10 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Algorithm efficacy (time frame: 15 days). 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 15 Mar 2023.