Clinical trial NCT06418464: Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Hebei Provincial People's Hospital
name: Xingtai People's Hospital
First posted: 2024-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Voluntary signing of an informed consent form.
2. Age between 18 and 70 years, with a T1D diagnosis of at least one year.
3. 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.
4. Receiving intensified treatment regimen with multiple daily subcutaneous insulin injections upon screening and during the whole study period.

Exclusion Criteria:

1. Conditions such as diabetic ketoacidosis, diabetic ketosis, hyperglycemic hyperosmolar state, or other acute complications related to diabetes.
2. The presence of concurrent fever, severe infections, acute abdominal conditions, uncontrolled thyroid dysfunction, or the acute phase of any organ system disease.
3. 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.
4. 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.
5. Individuals who are required to fast or are unable to eat normally due to special circumstances.
6. Pregnant or breastfeeding women.
7. Individuals suffering from psychiatric illnesses or other cognitive impairments that may affect their ability to participate in the study.
8. 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.
9. The systemic use of corticosteroids within the last month, with the exception of inhaled or topical steroids.
10. Any other condition or reason that the researcher deems to make the participant unsuitable for inclusion in the study.

Primary outcomes:
measure: Time in Range (TIR)
timeFrame: At the end of the treatment period
Secondary outcomes:
measure: Time Below Range (TBR)
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes1
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes2
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes3
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes4
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes5
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes6
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes7
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes8
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes9
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes10
timeFrame: At the end of the treatment period
measure: Other Secondary Outcomes11
timeFrame: At the end of the treatment period
Other outcomes:
Locations:
Study officials:
References: