Type 1 Diabetes Mellitus With Artificial Pancreas DeviceNCT05809843
OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device
An observational study of Type 1 Diabetes Mellitus With Artificial Pancreas Device, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus With Artificial Pancreas Device
- What is being tested?
- hybrid artificial pancreas systems (CSII)
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2023to 23 Mar 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participans were older than 18 years with diagnosis of type 1 diabetes treated with artificial pancreas device. They did not present other ophthalmological disease
Who may be able to join
- • age older than 18 years
- diagnosis of type 1 diabetes
- treatment with artificial pancreas device
- absence of previous ocular surgery and congenital eye diseases.
- absence of errors of refraction
- absence of lens opacities
- absence of low-quality OCT and OCTA images
Who cannot join
- age younger than 18 years
- previous ocular surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device
This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.
Read the detailed description
hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.
The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.
- Being tested
- hybrid artificial pancreas systems (CSII)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid artificial pancreas systems (CSII)Device
artificial device that adjust the patient's glycemic levels with insulin doses appropriate to the patient's blood glucose
| Study group | Role | What they receive |
|---|---|---|
| rype 1 diabetc patients with artificial pancreas device | Not described Receives: Device: hybrid artificial pancreas systems (CSII) | |
| healthy patients matched age and sex without diabetes and ocular disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device
Measured: up to 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start30 Jan 2023
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With Artificial Pancreas DeviceStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809843
- Sponsor's protocol ID
- 2403/2023
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device
- ClinicalTrials.gov ID
- NCT05809843
- Acronym / sponsor ID
- 2403/2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 12 Apr 2023 (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.
This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.
Detailed description
hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.
The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rype 1 diabetc patients with artificial pancreas device | – | Device: hybrid artificial pancreas systems (CSII) |
| healthy patients matched age and sex without diabetes and ocular disease | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 18 years with diagnosis of type 1 diabetes treated with artificial pancreas device. They did not present other ophthalmological disease
Key inclusion criteria (7 listed)
- • age older than 18 years
Key exclusion criteria (5 listed)
- age younger than 18 years
- previous ocular surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
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 |
|---|---|---|
| hybrid artificial pancreas systems (CSII)artificial device that adjust the patient's glycemic levels with insulin doses appropriate to the patient's blood glucose | Device | rype 1 diabetc patients with artificial pancreas device |
Primary outcome
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device
Time frame: up to 3months
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device
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 12 Apr 2023.
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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.
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 Type 1 Diabetes Mellitus With Artificial Pancreas Device, run by Federico II University at 1 site in Italy.
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 7 inclusion and 5 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 12 Apr 2023. 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 Italy. 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?
The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device (time frame: up to 3months). 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 12 Apr 2023.