DiabetesNCT06434584
Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
An observational study of Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- without AI assistance, with AI dosage assistance and with explainable AI assistance
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2022to 10 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: include 40 patient cases and 8 doctors (4 senior and 4 junior)
Who may be able to join
- Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
- Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.
- licensed medical practitioner.
Who cannot join
- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose >40%).
- Doctor
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.
- Conditions
- Diabetes
- Being tested
- without AI assistance, with AI dosage assistance, with explainable AI assistance, with faulty explainable AI assistance
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without AI assistanceOther
provide insulin dosage and confidence score without AI assistance
with AI dosage assistanceOther
provide insulin dosage and confidence score with AI dosage assistance
with explainable AI assistanceOther
provide insulin dosage and confidence score with explainable AI assistance
with faulty explainable AI assistanceOther
provide insulin dosage and confidence score with faulty explainable AI assistance
| Study group | Role | What they receive |
|---|---|---|
| senior doctor group | Not described Receives: Other: without AI assistance; Other: with AI dosage assistance; Other: with explainable AI assistance; Other: with faulty explainable AI assistance | |
| junior doctor group | Not described Receives: Other: without AI assistance; Other: with AI dosage assistance; Other: with explainable AI assistance; Other: with faulty explainable AI assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doctors' decision-making accuracy
The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses.
- Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard).
- Clinical agreement: Clinical agreement is calculated as the proportion of clinically consistent insulin doses (clinician-given adjustments in the same direction as the expert's protocol and within 20% of the dose difference) to the total insulin dose.
Measured: up to 2 months
Doctors' decision-making confidence
Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start10 Dec 2022
- Primary completion20 Mar 2023
- Study completion10 Jun 2023
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.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, Professor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434584
- Sponsor's protocol ID
- 20240218043800077
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
- ClinicalTrials.gov ID
- NCT06434584
- Acronym / sponsor ID
- 20240218043800077
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 30 May 2024 (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 investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senior doctor group | – | Other: without AI assistance, Other: with AI dosage assistance, Other: with explainable AI assistance, Other: with faulty explainable AI assistance |
| junior doctor group | – | Other: without AI assistance, Other: with AI dosage assistance, Other: with explainable AI assistance, Other: with faulty explainable AI assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- include 40 patient cases and 8 doctors (4 senior and 4 junior)
Key inclusion criteria (3 listed)
- Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
- Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.
- licensed medical practitioner.
Key exclusion criteria (2 listed)
- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose >40%).
- Doctor
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 |
|---|---|---|
| without AI assistanceprovide insulin dosage and confidence score without AI assistance | Other | junior doctor group, senior doctor group |
| with AI dosage assistanceprovide insulin dosage and confidence score with AI dosage assistance | Other | junior doctor group, senior doctor group |
| with explainable AI assistanceprovide insulin dosage and confidence score with explainable AI assistance | Other | junior doctor group, senior doctor group |
| with faulty explainable AI assistanceprovide insulin dosage and confidence score with faulty explainable AI assistance | Other | junior doctor group, senior doctor group |
Primary outcome
Doctors' decision-making accuracy
Time frame: up to 2 months
The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses. 1. Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard). 2. Clinical agreement: Clinical agreement is calculated as the proportion of clinically consistent insulin doses (clinician-given adjustments in the same direction as the expert's protocol and within 20% of the dose difference) to the total insulin dose.
Doctors' decision-making confidence
Time frame: up to 2 months
Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).
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 30 May 2024.
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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.
Xiaoying Li, Professor study chair
Fudan University
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 Shanghai Zhongshan Hospital at 1 site in China.
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 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 30 May 2024. 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 China. 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?
Doctors' decision-making accuracy (time frame: up to 2 months). The study lists 2 primary outcomes in all. 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 30 May 2024.