Diabetes Mellitus, Type 1ELITENCT06418464
Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy
A study testing AP-A Dosage Decision Support System in people with Diabetes Mellitus, Type 1, run by Peking University People's Hospital.
Trial summary
This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- AP-A Dosage Decision Support System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signing of an informed consent form.
- Age between 18 and 70 years, with a T1D diagnosis of at least one year.
- A confirmed diagnosis of T1D diabetes by at least two endocrinologists and fulfillment of at least one of the following conditions: a) Fasting C-peptide level less than 0.3 ng/mL. b) Fasting C-peptide level between 0.3 ng/mL and 0.6 ng/mL with at least one positive diabetic autoantibody.
- Receiving intensified treatment regimen with multiple daily subcutaneous insulin injections upon screening and during the whole study period.
Who cannot join
- Conditions such as diabetic ketoacidosis, diabetic ketosis, hyperglycemic hyperosmolar state, or other acute complications related to diabetes.
- The presence of concurrent fever, severe infections, acute abdominal conditions, uncontrolled thyroid dysfunction, or the acute phase of any organ system disease.
- A history within the last 3 months of serious cardiovascular issues including decompensated heart failure (NYHA Class III or IV), myocardial infarction, coronary artery bypass grafting, or coronary stent implantation, as well as uncontrolled severe arrhythmias or ischemic or hemorrhagic stroke.
- Laboratory test abnormalities that exceed certain thresholds, such as alanine transaminase or aspartate transaminase levels greater than three times the upper limit of normal, total bilirubin levels more than twice the upper limit of normal, hemoglobin levels below 100 g/L, albumin levels below 30 g/L, or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m².
- Individuals who are required to fast or are unable to eat normally due to special circumstances.
- Pregnant or breastfeeding women.
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- Individuals suffering from psychiatric illnesses or other cognitive impairments that may affect their ability to participate in the study.
- Participants who are unable to wear a CGM due to severe allergies, skin diseases, or conditions at the sensor site such as lesions, scarring, redness, infection, or edema, which could interfere with the sensor's adhesion or the accuracy of glucose measurements in the interstitial fluid.
- The systemic use of corticosteroids within the last month, with the exception of inhaled or topical steroids.
- Any other condition or reason that the researcher deems to make the participant unsuitable for inclusion in the study.
About this study
Official title: Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy: Protocol of a Multi-center, Non-inferiority, Randomized Controlled Trial (ELITE Study)
This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. The trial is set to take place across three locations in China: Peking University People's Hospital, Hebei Provincial People's Hospital, and Xingtai People's Hospital. Before participating, all subjects are required to provide their consent by signing a written informed consent form. Within the framework of the trial, the intervention group will receive insulin dosage recommendations from AP-A, subject to approval by a physician, whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- AP-A Dosage Decision Support System
- 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.
AP-A Dosage Decision Support SystemDevice
The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System.
| Study group | Role | What they receive |
|---|---|---|
| AP-A Dosage Decision Support System | Experimental | The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. Receives: Device: AP-A Dosage Decision Support System |
| Physician decision-making | Active comparator | The injection dose of the control group was determined by the doctor solely. Receives: Device: AP-A Dosage Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR)
The proportion of time that the glucose levels, as recorded by CGM during the treatment period, are within the range of 3.9mmol/L to 10.0mmol/L. This metric can be directly obtained by the algorithm system through closed-loop reading of CGM data.
Measured: At the end of the treatment period
Secondary outcomes (12)
Time Below Range (TBR)
The proportion of time that the glucose levels, as recorded by CGM during the treatment adjustment period, are below 3.9mmol/L.
Measured: At the end of the treatment period
Other Secondary Outcomes1
The proportion of glucose data stored by CGM during the treatment period that is in the range of 3.0-3.8mmol/L.
Measured: At the end of the treatment period
Other Secondary Outcomes2
The proportion of glucose data stored by CGM during the treatment adjustment period that is below 3.0mmol/L.
Measured: At the end of the treatment period
Other Secondary Outcomes3
The area under the curve (AUC) of glucose levels below 3.9mmol/L in the Ambulatory Glucose Profile (AGP) during the treatment adjustment period.
Measured: At the end of the treatment period
Other Secondary Outcomes4
The proportion of glucose data stored by CGM during the treatment adjustment period that is above 10.0mmol/L.
Measured: At the end of the treatment period
Other Secondary Outcomes5
The proportion of glucose data stored by CGM during the treatment adjustment period that is above 13.3mmol/L.
Measured: At the end of the treatment period
Other Secondary Outcomes6
The area under the curve (AUC) of glucose levels below 10.0mmol/L in the AGP during the treatment adjustment period.
Measured: At the end of the treatment period
Other Secondary Outcomes7
The mean of the glucose data stored by CGM during the treatment adjustment period (MEAN).
Measured: At the end of the treatment period
Other Secondary Outcomes8
The standard deviation of the glucose data stored by CGM during the treatment adjustment period (SD).
Measured: At the end of the treatment period
Other Secondary Outcomes9
The discrepancy between the physician-approved dosage and the AI-recommended dosage in the intervention group.
Measured: At the end of the treatment period
Other Secondary Outcomes10
The number of times the physician-approved dosage differs from the AI-recommended dosage in the intervention group.
Measured: At the end of the treatment period
Other Secondary Outcomes11
In the intervention group, the proportion of time that the glucose levels are within the range of 3.9mmol/L to 10.0mmol/L within 4 hours after insulin injection when there is a discrepancy between the physician-approved dosage and the algorithm-recommended dosage.
Measured: At the end of the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 Peking University People's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial People's Hospital, Xingtai People's Hospital
- Responsible party
- Principal investigator, Wei Liu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418464
- Sponsor's protocol ID
- 2023YFE0204100
- Acronym
- ELITE
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy: Protocol of a Multi-center, Non-inferiority, Randomized Controlled Trial (ELITE Study)
- ClinicalTrials.gov ID
- NCT06418464
- Acronym / sponsor ID
- ELITE / 2023YFE0204100
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Hebei Provincial People's Hospital, Xingtai People's Hospital
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 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.
This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. The trial is set to take place across three locations in China: Peking University People's Hospital, Hebei Provincial People's Hospital, and Xingtai People's Hospital. Before participating, all subjects are required to provide their consent by signing a written informed consent form. Within the framework of the trial, the intervention group will receive insulin dosage recommendations from AP-A, subject to approval by a physician, whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP-A Dosage Decision Support System | Experimental | Device: AP-A Dosage Decision Support SystemThe AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. |
| Physician decision-making | Active comparator | Device: AP-A Dosage Decision Support SystemThe injection dose of the control group was determined by the doctor solely. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary signing of an informed consent form.
- Age between 18 and 70 years, with a T1D diagnosis of at least one year.
- A confirmed diagnosis of T1D diabetes by at least two endocrinologists and fulfillment of at least one of the following conditions: a) Fasting C-peptide level less than 0.3 ng/mL. b) Fasting C-peptide level between 0.3 ng/mL and 0.6 ng/mL with at least one positive diabetic autoantibody.
- Receiving intensified treatment regimen with multiple daily subcutaneous insulin injections upon screening and during the whole study period.
Key exclusion criteria (10 listed)
- Conditions such as diabetic ketoacidosis, diabetic ketosis, hyperglycemic hyperosmolar state, or other acute complications related to diabetes.
- The presence of concurrent fever, severe infections, acute abdominal conditions, uncontrolled thyroid dysfunction, or the acute phase of any organ system disease.
- A history within the last 3 months of serious cardiovascular issues including decompensated heart failure (NYHA Class III or IV), myocardial infarction, coronary artery bypass grafting, or coronary stent implantation, as well as uncontrolled severe arrhythmias or ischemic or hemorrhagic stroke.
- Laboratory test abnormalities that exceed certain thresholds, such as alanine transaminase or aspartate transaminase levels greater than three times the upper limit of normal, total bilirubin levels more than twice the upper limit of normal, hemoglobin levels below 100 g/L, albumin levels below 30 g/L, or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m².
- Individuals who are required to fast or are unable to eat normally due to special circumstances.
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 |
|---|---|---|
| AP-A Dosage Decision Support SystemThe AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. | Device | AP-A Dosage Decision Support System, Physician decision-making |
Primary outcome
Time in Range (TIR)
Time frame: At the end of the treatment period
The proportion of time that the glucose levels, as recorded by CGM during the treatment period, are within the range of 3.9mmol/L to 10.0mmol/L. This metric can be directly obtained by the algorithm system through closed-loop reading of CGM data.
12 secondary outcomes
Time Below Range (TBR)
Time frame: At the end of the treatment period
Other Secondary Outcomes1
Time frame: At the end of the treatment period
Other Secondary Outcomes2
Time frame: At the end of the treatment period
Other Secondary Outcomes3
Time frame: At the end of the treatment period
Other Secondary Outcomes4
Time frame: At the end of the treatment period
Other Secondary Outcomes5
Time frame: At the end of the treatment period
Other Secondary Outcomes6
Time frame: At the end of the treatment period
Other Secondary Outcomes7
Time frame: At the end of the treatment period
Other Secondary Outcomes8
Time frame: At the end of the treatment period
Other Secondary Outcomes9
Time frame: At the end of the treatment period
Other Secondary Outcomes10
Time frame: At the end of the treatment period
Other Secondary Outcomes11
Time frame: At the end of the treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AP-A Dosage Decision Support System in people with Diabetes Mellitus, Type 1, run by Peking University People's Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Time in Range (TIR) (time frame: At the end of the treatment period). 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 17 May 2024.