T2DM Patients With Traumatic Brain InjuryNCT06909071
Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
A study testing Hybrid Closed-Loop Artificial Pancreas System in people with T2DM Patients With Traumatic Brain Injury, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM Patients With Traumatic Brain Injury
- What is being tested?
- Hybrid Closed-Loop Artificial Pancreas System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old.
- Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2020 edition) .
- Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
- Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.
Who cannot join
- Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
- Patients with type 1 diabetes or other special types of diabetes.
- Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
- Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
- Populations and contraindications that are not suitable for insulin pump treatment.
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- Patients with allergic constitution and those who are allergic to adhesive tape.
- Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.
- Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.
- Other situations that the researcher deems inappropriate for participating in the clinical trial.
- Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.
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 the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial
In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.
Read the detailed description
According to the inclusion and exclusion criteria, 40 perioperative patients with type 2 diabetes mellitus (T2DM) will be screened and enrolled from the neurosurgical ward of Shanxi Bethune Hospital. They will be randomly divided into two groups: 20 patients in the hybrid closed-loop artificial pancreas system group and 20 patients in the traditional pump combined with continuous glucose monitoring (CGM) group. Both groups of patients will use continuous glucose monitoring to measure blood glucose levels. After collecting baseline data, the two groups of patients will receive short-term intensive insulin therapy according to the above-mentioned plans. Relevant clinical data will be collected during and after the treatment to compare the advantages and disadvantages of the two intensive insulin treatment plans in controlling blood glucose levels in perioperative T2DM patients undergoing neurosurgery and their impact on complications.
- Being tested
- Hybrid Closed-Loop Artificial Pancreas System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed-Loop Artificial Pancreas SystemDevice
The total daily insulin requirement is calculated as 0.3 - 0.6 U/(kg·d) according to patient's weight. The system automatically adjusts the basal rate during operation. Nurses enter bolus dose orders in AAPS software as directed by physicians. Blood glucose is monitored via continuous glucose monitoring and 4 daily fingerstick measurements (fasting and 2 hours after each meal).
| Study group | Role | What they receive |
|---|---|---|
| Traditional insulin pump group | Placebo comparator | Based on the patient's weight, the total daily insulin requirement is calculated at 0.3~0.6U/(kg*d) and distributed before meals according to the specific conditions of the patient. Continuous glucose monitoring system is used along with daily capillary blood glucose monitoring (fasting, 2 hours after breakfast, lunch, and dinner, totaling 4 times). Insulin doses are adjusted according to the patient's blood glucose level until the target blood glucose level is achieved. Receives: Device: Hybrid Closed-Loop Artificial Pancreas System |
| Hybrid Closed-Loop Artificial Pancreas System Group | Experimental | The open-source hybrid closed-loop artificial pancreas system, utilizing ultra-rapid-acting insulin, was employed for perioperative blood glucose management in neurosurgery. Insulin requirements were calculated based on patient weight. The system auto-adjusted basal rates according to blood glucose, while bolus treatments were manually inputted by nurses following physician instructions. Continuous and daily capillary blood glucose monitoring were conducted. Receives: Device: Hybrid Closed-Loop Artificial Pancreas System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR)
The percentage of time that blood glucose is within the target range of 6.0-12.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%
Measured: During the 5- to 7-day period of hospitalization
Secondary outcomes (8)
Blood glucose target criteria
FPG (fasting plasma glucose) or pre-prandial blood glucose of 8~10 mmol/L, 2hPG (2-hour postprandial glucose) or blood glucose at any time point when unable to eat is 8~12 mmol/L. General criteria: FPG or pre-prandial blood glucose of 6~8 mmol/L, 2hPG or blood glucose at any time point when unable to eat is 8~10 mmol/L (Expert Consensus on Perioperative Blood Glucose Monitoring for Adults - 2021) . The blood glucose target achievement rate within 1 week of insulin intensification therapy is calculated using the formula: Blood glucose target achievement rate = Number of patients achieving blood glucose targets / Total number of patients * 100%.
Measured: During the 5- to 7-day period of hospitalization
Time Below Range (TBR)、Time Above Range (TAR)
Time Below Range (TBR) refers to the percentage of time when blood glucose is below the target range, that is, blood glucose < 3.9 mmol/L. The calculation formula is: TBR = (Time with blood glucose < 3.9 mmol/L) / Total Time × 100%.
Time Above Range (TAR) refers to the percentage of time when blood glucose is above the target range, that is, blood glucose > 10.0 mmol/L. The calculation formula is: TAR = (Time with blood glucose > 10.0 mmol/L) / Total Time × 100%.
Measured: During the 5- to 7-day period of hospitalization
Hypoglycemia Incidence Rate
Using a blood glucose range of 3.0 - 3.9 mmol/L as the diagnostic criterion for hypoglycemia, the incidence of hypoglycemia during the treatment process in the two groups was counted and compared. Taking a blood glucose level < 3.0 mmol/L as the diagnostic criterion for severe hypoglycemia, the incidence of severe hypoglycemia during the treatment process in the two groups was also counted and compared.
Measured: During the 5- to 7-day period of hospitalization
Blood glucose fluctuation level (IQR)
The 25th and 75th percentile values of the blood glucose fluctuation range
Measured: During the 5- to 7-day period of hospitalization
Perioperative Infection Rate and Inflammatory Markers
The percentage of patients with fever, positive bacterial culture of incision secretions, other secretions or blood during the perioperative period, calculated as (Number of patients with positive results / Total number of patients) × 100%. Perioperative inflammatory indicators include white blood cell count (WBC), percentage of neutrophils, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin, etc.
Measured: During the 5- to 7-day period of hospitalization
Adverse event（AE）、Serious adverse event（SAE）
Adverse events are defined as any unfavorable medical events that occur during the use of the investigational medical device, regardless of whether they are related to the device. Serious adverse events are defined as events that result in death or a serious deterioration of the health status during the clinical trial. The incidences of adverse events and serious adverse events during the treatment process in the three groups were statistically analyzed and compared.
Measured: During the 5- to 7-day period of hospitalization
Perioperative infection rate and inflammatory markers
The perioperative infection rate is calculated as the number of patients who develop fever, have incision secretions, positive bacterial cultures from other secretions or blood during the perioperative period divided by the total number of patients, multiplied by 100%. Perioperative inflammatory markers include white blood cell count (WBC), percentage of neutrophils, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin, etc.
Measured: During the 5- to 7-day period of hospitalization
Suture removal time, total hospital stay days, and postoperative hospital stay days
Suture removal time, total hospital stay days, and postoperative hospital stay days
Measured: During the 5- to 7-day period of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 Apr 2025 (estimated)
- 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 T2DM Patients With Traumatic Brain InjuryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06909071
- Sponsor's protocol ID
- YXLL-2025-083
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 23 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06909071
- Acronym / sponsor ID
- YXLL-2025-083
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 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.
In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.
Detailed description
According to the inclusion and exclusion criteria, 40 perioperative patients with type 2 diabetes mellitus (T2DM) will be screened and enrolled from the neurosurgical ward of Shanxi Bethune Hospital. They will be randomly divided into two groups: 20 patients in the hybrid closed-loop artificial pancreas system group and 20 patients in the traditional pump combined with continuous glucose monitoring (CGM) group. Both groups of patients will use continuous glucose monitoring to measure blood glucose levels. After collecting baseline data, the two groups of patients will receive short-term intensive insulin therapy according to the above-mentioned plans. Relevant clinical data will be collected during and after the treatment to compare the advantages and disadvantages of the two intensive insulin treatment plans in controlling blood glucose levels in perioperative T2DM patients undergoing neurosurgery and their impact on complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional insulin pump group | Placebo comparator | Device: Hybrid Closed-Loop Artificial Pancreas SystemBased on the patient's weight, the total daily insulin requirement is calculated at 0.3~0.6U/(kg*d) and distributed before meals according to the specific conditions of the patient. Continuous glucose monitoring system is used along with daily capillary blood glucose monitoring (fasting, 2 hours after breakfast, lunch, and dinner, totaling 4 times). Insulin doses are adjusted according to the patient's blood glucose level until the target blood glucose level is achieved. |
| Hybrid Closed-Loop Artificial Pancreas System Group | Experimental | Device: Hybrid Closed-Loop Artificial Pancreas SystemThe open-source hybrid closed-loop artificial pancreas system, utilizing ultra-rapid-acting insulin, was employed for perioperative blood glucose management in neurosurgery. Insulin requirements were calculated based on patient weight. The system auto-adjusted basal rates according to blood glucose, while bolus treatments were manually inputted by nurses following physician instructions. Continuous and daily capillary blood glucose monitoring were conducted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years old.
- Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2020 edition) .
- Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
- Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.
Key exclusion criteria (11 listed)
- Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
- Patients with type 1 diabetes or other special types of diabetes.
- Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
- Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
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 SystemThe total daily insulin requirement is calculated as 0.3 - 0.6 U/(kg·d) according to patient's weight. The system automatically adjusts the basal rate during operation. Nurses enter bolus dose orders in AAPS software as directed by physicians. Blood glucose is monitored via continuous glucose monitoring and 4 daily fingerstick measurements (fasting and 2 hours after each meal). | Device | Hybrid Closed-Loop Artificial Pancreas System Group, Traditional insulin pump group |
Primary outcome
Time in Range (TIR)
Time frame: During the 5- to 7-day period of hospitalization
The percentage of time that blood glucose is within the target range of 6.0-12.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%
8 secondary outcomes
Blood glucose target criteria
Time frame: During the 5- to 7-day period of hospitalization
Time Below Range (TBR)、Time Above Range (TAR)
Time frame: During the 5- to 7-day period of hospitalization
Hypoglycemia Incidence Rate
Time frame: During the 5- to 7-day period of hospitalization
Blood glucose fluctuation level (IQR)
Time frame: During the 5- to 7-day period of hospitalization
Perioperative Infection Rate and Inflammatory Markers
Time frame: During the 5- to 7-day period of hospitalization
Adverse event（AE）、Serious adverse event（SAE）
Time frame: During the 5- to 7-day period of hospitalization
Perioperative infection rate and inflammatory markers
Time frame: During the 5- to 7-day period of hospitalization
Suture removal time, total hospital stay days, and postoperative hospital stay days
Time frame: During the 5- to 7-day period of hospitalization
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 23 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.
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 T2DM Patients With Traumatic Brain Injury, 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 4 inclusion and 11 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 23 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 (+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 in Range (TIR) (time frame: During the 5- to 7-day period of hospitalization). 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 23 Apr 2025.