Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanxi Bethune Hospital
About this trial
Based on the difficulties in blood glucose control among the Latent Autoimmune Diabetes in Adults (LADA) population and the deficiencies of previous studies, this research aims to conduct a clinical comparative study. The short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and Continuous Glucose Monitoring (CGM) in hospitalized LADA patients will be evaluated to explore the clinical application value of these methods in LADA patients. Moreover, this study aims to provide a more precise and personalized blood glucose management plan for LADA patients. As a slowly progressive subtype of autoimmune type 1 diabetes mellitus (T1DM), LADA patients have significant differences in pathological characteristics, clinical needs, and treatment effects compared with classical T1DM patients. However, they also face huge challenges in blood glucose management. This study will focus on LADA patients for the first time, especially the group of hospitalized patients, to fill the gap in this field. Meanwhile, by introducing the cutting-edge closed-loop system technology, it will provide new ideas and solutions for the clinical blood glucose management of LADA patients. Through a comparative analysis of the short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and CGM, this study aims to provide more precise and personalized treatment strategies for LADA patients and promote the further development of diabetes treatment technologies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years old.
The onset age of diabetes is ≥ 18 years old.
Positive for islet autoantibodies or islet autoimmunity T cells.
Do not rely on insulin therapy for at least 6 months after the diagnosis of diabetes.
Disqualifiers
The patient has been clearly diagnosed with type 2 diabetes or special types of diabetes.
The patient has experienced acute diabetic complications within the past 1 month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
The patient has severe symptoms of hypoglycemia intolerance.
The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid Closed-Loop Artificial Pancreas System
Other interventionHybrid Closed-Loop Artificial Pancreas System Group: Uses an open-source system with Novo Nordisk ultra-rapid-acting insulin (approval: J20050097, 3 mL: 300 U). Daily insulin dose calculated at 0.3-0.6 U/(kg\*d) based on weight; system auto-adjusts basal rate. Physicians prescribe bolus doses, entered by nurses via AAPS software. Glucose correction uses CGM + 4 daily capillary tests (fasting, 2h post-meal). AAPS features hypoglycemia prediction suspend (pauses basal if glucose ≤4.4 mmol/L, resumes upon recovery) and alarms (\<3.9 mmol/L, ensures nighttime alert).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Hybrid Closed-Loop Artificial Pancreas System with CGM GroupExperimental treatment 1 intervention
Group B: Conventional Insulin Pump Combined with CGM GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time required to achieve 70% TIR
Time in Range (TIR) refers to the percentage of time that blood glucose levels are within the target range of 3.9 to 10.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%
Time frame
2 years2
TIR achievement rate after 5 days of treatment
Time in Range (TIR) refers to the percentage of time that blood glucose levels are within the target range of 3.9 to 10.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%
Time frame
5 daysSecondary outcomes
1
Blood Glucose Control Rate
The criteria for blood glucose target achievement are as follows: fasting blood glucose should be controlled within 4.0 - 7.0 mmol/L, postprandial blood glucose within 5.0 - 10.0 mmol/L, and blood glucose before going to bed within 4.4 - 7.8 mmol/L. The rate of blood glucose target achievement within 1 week of intensive insulin therapy will be statistically analyzed. The calculation formula is: Rate of blood glucose target achievement = (Number of patients achieving blood glucose targets / Total number of patients) × 100%
Time frame
2 years2
Time Below Range (TBR)、Time Above Range (TAR)
Time below the blood glucose target range, which is the percentage of time that blood glucose is below the target range of 3.9 mmol/L. The calculation formula is: TBR = (Time when blood glucose \< 3.9 mmol/L in the target range / Total time) × 100%. Time above the blood glucose target range, which is the percentage of time that blood glucose is above the target range of 10.0 mmol/L. The calculation formula is: TAR = (Time when blood glucose \> 10.0 mmol/L in the target range / Total time) × 100%.
Time frame
2 years3
Hypoglycemia Incidence Rate
The diagnostic criterion for hypoglycemia is a blood glucose level of 3.0 - 3.9 mmol/L. The hypoglycemia incidence rates during the treatment process in the two groups will be counted and compared. The diagnostic criterion for severe hypoglycemia is a blood glucose level \< 3.0 mmol/L. The severe hypoglycemia incidence rates during the treatment process in the two groups will be counted and compared.
Time frame
2 years4
Inter-quartile Range (IQR) of Blood Glucose
The 25th and 75th percentile values of the blood glucose fluctuation range (inter - quartile range, IQR).
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov