Latent Autoimmune Diabetes in Adults (LADA)NCT06941675
Hybrid Closed-Loop System in LADA Patients: A Randomized Trial
A study testing Hybrid Closed-Loop Artificial Pancreas System in people with Latent Autoimmune Diabetes in Adults (LADA), run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Latent Autoimmune Diabetes in Adults (LADA)
- What is being tested?
- Hybrid Closed-Loop Artificial Pancreas System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 70 years old.
- Meet the diagnostic criteria for LADA in the "Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)":
- 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.
- Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.
- Baseline HbA1c > 7.0% or HbA1c > 6.0% combined with hypoglycemia.
- Patients agree to participate in the study and sign the informed consent form.
Who cannot join
- 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.
- The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- The patient has comorbid severe liver, kidney, gastrointestinal, hematological, brain, circulatory system diseases, etc.
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- The patient has other severe chronic diseases (such as malignant tumors, end-stage organ failure, etc.).
- The patient has impaired consciousness or mental illness, lacks self-control, and cannot express clearly.
- Lactating women, pregnant women, or women who plan to become pregnant during the trial period.
- The patient is currently using or has used glucocorticoids or other drugs that interfere with glucose metabolism within 1 month before screening.
- The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.
- The patient is currently using other closed-loop systems.
- People who are not suitable for conventional insulin pump treatment and those with contraindications.
- The patient is known or suspected to have an insulin-allergic constitution and is allergic to adhesive tape, insulin pumps, or CGM devices.
- Other situations where the researcher deems the patient unfit to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Li Chen, Master, 13603530358 ext. 0351-8379146, chenli253@163.com
About this study
Official title: Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Latent Autoimmune Diabetes in Adults (LADA): An Open-Label, Randomized Controlled 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.
Read the detailed description
This study aims to compare the clinical effects of a hybrid closed-loop artificial pancreas system and a traditional insulin pump in hospitalized patients with Latent Autoimmune Diabetes in Adults (LADA) through a single-center, open-label, randomized controlled trial. Referring to the designs of similar clinical trials, the number of cases in each group of this study is determined to be 25, with a total of 50 cases. The study subjects are LADA patients hospitalized in the Department of Endocrinology of Shanxi Bethune Hospital from April 2025 to April 2027. The study design is as follows: Starting from the second 24-hour period after the patient's admission, with each subsequent 24-hour period as a monitoring unit, after collecting baseline data, the patients are randomly divided into two groups: the closed-loop system group and the control group. The closed-loop system group uses a hybrid closed-loop artificial pancreas system combined with Continuous Glucose Monitoring (CGM), while the control group continues to use a traditional insulin pump combined with CGM. During the study, both groups wear CGM devices for continuous monitoring, and relevant clinical data are collected during and after the treatment for statistical analysis to compare the short-term blood glucose control effects of the two intensive insulin treatment regimens in hospitalized LADA patients.
- Being tested
- Hybrid Closed-Loop Artificial Pancreas System
- Medical subject headings
- Latent Autoimmune Diabetes in Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed-Loop Artificial Pancreas SystemOther
Hybrid 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).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Closed-Loop Artificial Pancreas System with CGM Group | Experimental | This group uses an open-source hybrid closed-loop artificial pancreas system with ultra-rapid-acting insulin (Novo Nordisk, Denmark). Daily insulin needs are calculated based on weight (0.3-0.6U/kg/day) \& adjusted by the system. Physicians provide bolus instructions, entered by nurses. CGM \& daily finger pricks are used for monitoring \& calibration. The system predicts \& prevents hypoglycemia, halting insulin when BG ≤ 4.4mmol/L. An alarm alerts for BG <3.9mmol/L. Receives: Other: Hybrid Closed-Loop Artificial Pancreas System |
| Conventional Insulin Pump Combined with CGM Group | Placebo comparator | According to the patient's weight, the total daily insulin requirement is calculated at a rate of 0.3 - 0.6 U/(kg·d) and distributed to pre-meal administrations based on the patient's specific condition. Blood glucose is monitored using a continuous glucose monitoring system in combination with daily fingerstick capillary blood glucose measurements (fasting blood glucose, and blood glucose 2 hours after breakfast, lunch, and dinner, for a total of 4 measurements). Insulin dosage is adjusted according to the patient's blood glucose levels until the blood glucose reaches the target level. Receives: Other: Hybrid Closed-Loop Artificial Pancreas System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 2 years
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%
Measured: 5 days
Secondary outcomes (6)
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%
Measured: 2 years
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%.
Measured: 2 years
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.
Measured: 2 years
Inter-quartile Range (IQR) of Blood Glucose
The 25th and 75th percentile values of the blood glucose fluctuation range (inter - quartile range, IQR).
Measured: 2 years
Average Daily Insulin Dosage
During the calculation period, record the specific dose of each injection every day.
Measured: 2 years
Adverse Event
Count and compare the incidences of adverse events and serious adverse events during the treatment process between the two groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Autoimmune Diabetes in Adults (LADA)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941675
- Sponsor's protocol ID
- YXLL-2025-082
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If there is a need to use data, please contact the person in charge and follow the relevant procedures to achieve data sharing. Without permission, do not use the data directly.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Latent Autoimmune Diabetes in Adults (LADA): An Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06941675
- Acronym / sponsor ID
- YXLL-2025-082
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Apr 2025 (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.
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.
Detailed description
This study aims to compare the clinical effects of a hybrid closed-loop artificial pancreas system and a traditional insulin pump in hospitalized patients with Latent Autoimmune Diabetes in Adults (LADA) through a single-center, open-label, randomized controlled trial. Referring to the designs of similar clinical trials, the number of cases in each group of this study is determined to be 25, with a total of 50 cases. The study subjects are LADA patients hospitalized in the Department of Endocrinology of Shanxi Bethune Hospital from April 2025 to April 2027. The study design is as follows: Starting from the second 24-hour period after the patient's admission, with each subsequent 24-hour period as a monitoring unit, after collecting baseline data, the patients are randomly divided into two groups: the closed-loop system group and the control group. The closed-loop system group uses a hybrid closed-loop artificial pancreas system combined with Continuous Glucose Monitoring (CGM), while the control group continues to use a traditional insulin pump combined with CGM. During the study, both groups wear CGM devices for continuous monitoring, and relevant clinical data are collected during and after the treatment for statistical analysis to compare the short-term blood glucose control effects of the two intensive insulin treatment regimens in hospitalized LADA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Closed-Loop Artificial Pancreas System with CGM Group | Experimental | Other: Hybrid Closed-Loop Artificial Pancreas SystemThis group uses an open-source hybrid closed-loop artificial pancreas system with ultra-rapid-acting insulin (Novo Nordisk, Denmark). Daily insulin needs are calculated based on weight (0.3-0.6U/kg/day) \& adjusted by the system. Physicians provide bolus instructions, entered by nurses. CGM \& daily finger pricks are used for monitoring \& calibration. The system predicts \& prevents hypoglycemia, halting insulin when BG ≤ 4.4mmol/L. An alarm alerts for BG <3.9mmol/L. |
| Conventional Insulin Pump Combined with CGM Group | Placebo comparator | Other: Hybrid Closed-Loop Artificial Pancreas SystemAccording to the patient's weight, the total daily insulin requirement is calculated at a rate of 0.3 - 0.6 U/(kg·d) and distributed to pre-meal administrations based on the patient's specific condition. Blood glucose is monitored using a continuous glucose monitoring system in combination with daily fingerstick capillary blood glucose measurements (fasting blood glucose, and blood glucose 2 hours after breakfast, lunch, and dinner, for a total of 4 measurements). Insulin dosage is adjusted according to the patient's blood glucose levels until the blood glucose reaches the target level. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years old.
- Meet the diagnostic criteria for LADA in the "Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)":
- Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.
- Baseline HbA1c > 7.0% or HbA1c > 6.0% combined with hypoglycemia.
- Patients agree to participate in the study and sign the informed consent form.
Key exclusion criteria (15 listed)
- 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.
- The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
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 Closed-Loop Artificial Pancreas SystemHybrid 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). | Other | Conventional Insulin Pump Combined with CGM Group, Hybrid Closed-Loop Artificial Pancreas System with CGM Group |
Primary outcome
Time required to achieve 70% TIR
Time frame: 2 years
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%
TIR achievement rate after 5 days of treatment
Time frame: 5 days
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%
6 secondary outcomes
Blood Glucose Control Rate
Time frame: 2 years
Time Below Range (TBR)、Time Above Range (TAR)
Time frame: 2 years
Hypoglycemia Incidence Rate
Time frame: 2 years
Inter-quartile Range (IQR) of Blood Glucose
Time frame: 2 years
Average Daily Insulin Dosage
Time frame: 2 years
Adverse Event
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. If there is a need to use data, please contact the person in charge and follow the relevant procedures to achieve data sharing. Without permission, do not use the data directly.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Closed-Loop Artificial Pancreas System in people with Latent Autoimmune Diabetes in Adults (LADA), run by Shanxi Bethune 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiwei Liu, Doctor's degree (+86 13191072733 ext. 0351-2170956, lswspring6@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to achieve 70% TIR (time frame: 2 years). 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 24 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.