Diabetes MellitusNCT06295289
Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial
A study testing Hybrid Closed-loop Insulin Delivery System and Insulin pump in people with Diabetes Mellitus, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Hybrid Closed-loop Insulin Delivery System and Insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1）18~75 years old (including 18 years old and 75 years old),
- 2）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy;
- 3）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L;
- 4）Patients signed the informed consent form and volunteered to participate in the clinical trial.
- 5 ) Patients who have already undergone surgery and are still hospitalized during the perioperative period with poor glycemic control.
Who cannot join
- The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc.
- Type 1 diabetes mellitus
- Patients with severe cardiac and renal organ dysfunction: cardiac function above grade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White blood cell count <4.0×109/L or platelet count <90×109/L;
- Patients who are allergic to drugs specified in clinical protocols
- Patients who are not suitable for conventional insulin pump therapy.
- Patients who are allergic constitution and allergic to tape
Show all 10Show fewer
- Patients with skin diseases such as rash and prurigo, or abnormal coagulation function;
- Patients who suffer from mental illness, have no self-control, and cannot express themselves clearly.
- Other circumstances that investigator considered to be inappropriate for clinical trial participation;
- 10) Patients with severe complications during or after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period.
Read the detailed description
Hyperglycemia is particularly frequent in the perioperative period, which leads to metabolic and functional disorders, aggravates organ damage, induces various complications, and increases the risk of postoperative infection and even death.
However, glucose level management among perioperative patients remains challenging because of the frequent blood glucose monitoring requirement and insulin adjustment to accommodate the physiological changes of patients before surgery.
In this study, we planned to use an open-source, hybrid closed-loop insulin delivery system and common insulin pump combined with CGM for short-term intensive insulin therapy in patients with diabetes during the perioperative period. To comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop insulin delivery system, we planned to compare the blood glucose control and other clinical indicators such as postoperative complications of patients with different intensive insulin therapy regimens If the participant is enrolled before the surgery, the following procedure will be followed:
Preoperative: the participants wear the open-source AP system for treatment.
Intraoperative: participants should discontinue the insulin pump in advance, with the specific timing determined by the endocrinologist. The CGM can remain in place as long as it does not interfere with the surgery.
Postoperative: After the subject returns to the ward, the nurse will reinstall the open-source AP system, and the treatment will continue for at least 3-4 days.
- Conditions
- Diabetes Mellitus
- Being tested
- Hybrid Closed-loop Insulin Delivery System, Insulin pump
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed-loop Insulin Delivery SystemDevice
The Hybrid Closed-loop Insulin Delivery System system consisted of a Medtronic pump, a continuous glucose monitoring system（SIBIONICS®）and an open-source algorithm integrated into the phone. Insulin pump therapy group consisted of a Medtronic pump, and a continuous glucose monitoring system（SIBIONICS®). The difference between the two groups is that the artificial pancreas system automatically regulates the basal rate to maintain blood glucose in a target range.
Insulin pumpDevice
Participants used conventional insulin pumps to control blood glucose, At the same time, a continuous glucose monitoring system was used to monitor glucose changes. Health care providers adjust the insulin dose of patients according to their blood glucose level.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid closed-loop insulin delivery system group | Experimental | After patients signed the informed consent form in the ward, the nurse installed the insulin pump and the subcutaneous, real-time, continuous glucose monitor (CGM). The insulin pump was installed in the abdomen or upper arm, and the CGM was installed in the upper arm. A Hybrid closed-loop insulin delivery system with an open-source algorithm was set up for participants by the clinical trial investigators. The algorithm was initialized with the participant's weight and basal insulin requirements. The control algorithm modulated insulin delivery every 5 min based on the CGM glucose level, anticipated glucose trends, and patient-specific information such as the basal rate profile to guarantee blood glucose control within the target range. The perioperative patients in the hybrid closed-loop insulin delivery group who were admitted to the hospital received 3-5 days of glucose-lowering therapy. Receives: Device: Hybrid Closed-loop Insulin Delivery System |
| Insulin pump therapy group (Control group) | Placebo comparator | The insulin treatment with a pump and CGM was applied according to the local clinical guidelines. The insulin pump was installed in the abdomen or upper arm, and the CGM was inserted in the upper arm by the investigator. Doctors adjust the insulin dose according to the patient's glucose level. Receives: Device: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIR
time in range
Measured: 5-10days
Secondary outcomes (3)
TAR
time above range
Measured: 5-10days
TBR
time blow range
Measured: 5-10days
MBG
mean blood glucose
Measured: 5-10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start16 Oct 2023
- Primary completion4 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuefeng Yu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295289
- Sponsor's protocol ID
- ZRKY-2023-04
- Status last verified
- May 2025
- First submitted
- 28 Feb 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06295289
- Acronym / sponsor ID
- ZRKY-2023-04
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Mar 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.
Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period.
Detailed description
Hyperglycemia is particularly frequent in the perioperative period, which leads to metabolic and functional disorders, aggravates organ damage, induces various complications, and increases the risk of postoperative infection and even death.
However, glucose level management among perioperative patients remains challenging because of the frequent blood glucose monitoring requirement and insulin adjustment to accommodate the physiological changes of patients before surgery.
In this study, we planned to use an open-source, hybrid closed-loop insulin delivery system and common insulin pump combined with CGM for short-term intensive insulin therapy in patients with diabetes during the perioperative period. To comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop insulin delivery system, we planned to compare the blood glucose control and other clinical indicators such as postoperative complications of patients with different intensive insulin therapy regimens If the participant is enrolled before the surgery, the following procedure will be followed:
Preoperative: the participants wear the open-source AP system for treatment.
Intraoperative: participants should discontinue the insulin pump in advance, with the specific timing determined by the endocrinologist. The CGM can remain in place as long as it does not interfere with the surgery.
Postoperative: After the subject returns to the ward, the nurse will reinstall the open-source AP system, and the treatment will continue for at least 3-4 days.
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 insulin delivery system group | Experimental | Device: Hybrid Closed-loop Insulin Delivery SystemAfter patients signed the informed consent form in the ward, the nurse installed the insulin pump and the subcutaneous, real-time, continuous glucose monitor (CGM). The insulin pump was installed in the abdomen or upper arm, and the CGM was installed in the upper arm. A Hybrid closed-loop insulin delivery system with an open-source algorithm was set up for participants by the clinical trial investigators. The algorithm was initialized with the participant's weight and basal insulin requirements. The control algorithm modulated insulin delivery every 5 min based on the CGM glucose level, anticipated glucose trends, and patient-specific information such as the basal rate profile to guarantee blood glucose control within the target range. The perioperative patients in the hybrid closed-loop insulin delivery group who were admitted to the hospital received 3-5 days of glucose-lowering therapy. |
| Insulin pump therapy group (Control group) | Placebo comparator | Device: Insulin pumpThe insulin treatment with a pump and CGM was applied according to the local clinical guidelines. The insulin pump was installed in the abdomen or upper arm, and the CGM was inserted in the upper arm by the investigator. Doctors adjust the insulin dose according to the patient's glucose level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1）18~75 years old (including 18 years old and 75 years old),
- 2）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy;
- 3）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L;
- 4）Patients signed the informed consent form and volunteered to participate in the clinical trial.
- 5 ) Patients who have already undergone surgery and are still hospitalized during the perioperative period with poor glycemic control.
Key exclusion criteria (10 listed)
- The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc.
- Type 1 diabetes mellitus
- Patients with severe cardiac and renal organ dysfunction: cardiac function above grade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White blood cell count <4.0×109/L or platelet count <90×109/L;
- Patients who are allergic to drugs specified in clinical protocols
- Patients who are not suitable for conventional insulin pump therapy.
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 Insulin Delivery SystemThe Hybrid Closed-loop Insulin Delivery System system consisted of a Medtronic pump, a continuous glucose monitoring system（SIBIONICS®）and an open-source algorithm integrated into the phone. Insulin pump therapy group consisted of a Medtronic pump, and a continuous glucose monitoring system（SIBIONICS®). The difference between the two groups is that the artificial pancreas system automatically regulates the basal rate to maintain blood glucose in a target range. | Device | Hybrid closed-loop insulin delivery system group |
| Insulin pumpParticipants used conventional insulin pumps to control blood glucose, At the same time, a continuous glucose monitoring system was used to monitor glucose changes. Health care providers adjust the insulin dose of patients according to their blood glucose level. | Device | Insulin pump therapy group (Control group) |
Primary outcome
TIR
Time frame: 5-10days
time in range
3 secondary outcomes
TAR
Time frame: 5-10days
TBR
Time frame: 5-10days
MBG
Time frame: 5-10days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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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.
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 Insulin Delivery System and Insulin pump in people with Diabetes Mellitus, run by Huazhong University of Science and Technology 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 5 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: finished, as of the sponsor's last update on 23 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TIR (time frame: 5-10days). 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 May 2025.