Type 2 DiabetesNCT07121504
Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
A study testing Hybrid closed-loop insulin delivery system and conventional insulin pumps combined with CGM in people with Type 2 Diabetes, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hybrid closed-loop insulin delivery system and conventional insulin pumps combined with CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2025to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization >72 hours).
- Glycemic control criteria (meeting any of the following):
- ①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol/L
- Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.
- Willing to sign the informed consent form.
Who cannot join
- Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
- Patients with type 1 diabetes or other specific types of diabetes.
- Patients with severe organ dysfunction, defined as:
- Cardiac function ≥Class III (NYHA classification)
- ALT/AST >3× upper limit of normal (ULN) ③ eGFR ≤30 mL/min/1.73 m²
- Hemoglobin <90 g/L ⑤ WBC count <4.0×10⁹/L or platelets <90×10⁹/L ⑥ Hemodynamic instability
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- Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients with known hypersensitivity to any drugs or materials used in the study protocol.
- Patients who have contraindications to conventional insulin pump therapy.
- Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.
- Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.
- Patients who have other conditions deemed unsuitable for trial participation by investigators.
- Patients who suffer severe surgical complications.
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
Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011
Changsha, Hunan, 410011
Xia Li, +86 13974885753, lixia2014@vip.163.com
About this study
Official title: Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial
Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.
Read the detailed description
This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.
- Conditions
- Type 2 Diabetes
- Being tested
- Hybrid closed-loop insulin delivery system, conventional insulin pumps combined with CGM
- Keywords
- hybrid closed-loop, perioperative, parenteral nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperphagia
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
Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
conventional insulin pumps combined with CGMDevice
Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid closed-loop insulin delivery system | Experimental | T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system. Receives: Device: Hybrid closed-loop insulin delivery system |
| Conventional insulin pump with CGM | Active comparator | T2DM patients in the control group will receive conventional insulin pump therapy with CGM. Receives: Device: conventional insulin pumps combined with CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
Measured: Up to 28 days
Secondary outcomes (13)
Time above range (TAR) >10.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values > 10.0 mmol/L between group
Measured: Up to 28 days
Time above range (TAR) >20.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values > 20.0 mmol/L between group
Measured: Up to 28 days
Time below range (TBR) <5.6 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values <5.6 mmol/L between groups
Measured: Up to 28 days
Time below range (TBR) < 3.9 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values <3.9 mmol/L between groups
Measured: Up to 28 days
Time below range (TBR) < 3.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values <3.0 mmol/L between groups
Measured: Up to 28 days
Time below range (TBR) < 2.8 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values <2.8 mmol/L between groups
Measured: Up to 28 days
CGM-measured Mean Glucose Level
CGM-measured mean glucose level between groups
Measured: Up to 28 days
CGM-measured Glucose Standard Deviation (SD)
The difference in the CGM-measured glucose standard deviation between groups. Standard Deviation represents how much glucose levels fluctuate over time from a given average.
Measured: Up to 28 days
CGM-Measured Glucose Coefficient of Variation (CV)
The difference in the CGM-measured glucose coefficient of variation (CV) between groups. The CV is calculated as the ratio of the standard deviation to the mean glucose values for each participant, derived from CGM data.
Measured: Up to 28 days
CGM-Measured Glucose Risk Index (GRI)
The CGM-measured glucose risk index (GRI) between groups. GRI is a comprehensive metric derived from CGM data, designed to quantify the overall risk associated with blood glucose variability. It integrates multiple aspects of glucose levels, including the frequency and severity of both hypo- and hyperglycemic events, as well as the duration of time spent outside the target glucose range.
Measured: Up to 28 days
Insulin dose
The difference in the insulin dose between groups
Measured: Up to 28 days
Preoperative optimization duration (days)
The difference in the preoperative optimization duration between groups
Measured: Up to 28 days
Time in range (TIR) 4.4-10.0 mmol/L
The difference in percentage of time spent within target glucose range (4.4-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Li, Second Xiangya Hospital of Central South University
- Investigators
- Xia Li, MD, PhD, Principal investigator, Second Xiangya Hospial of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121504
- Sponsor's protocol ID
- HCL-T2D 2025
- Status last verified
- Aug 2025
- First submitted
- 22 May 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07121504
- Acronym / sponsor ID
- HCL-T2D 2025
- Conditions
- Type 2 Diabetes
- Keywords
- hybrid closed-loop, perioperative, parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Aug 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.
Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.
Detailed description
This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.
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 | Experimental | Device: Hybrid closed-loop insulin delivery systemT2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system. |
| Conventional insulin pump with CGM | Active comparator | Device: conventional insulin pumps combined with CGMT2DM patients in the control group will receive conventional insulin pump therapy with CGM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization >72 hours).
- Glycemic control criteria (meeting any of the following):
- ①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol/L
- Willing to sign the informed consent form.
Key exclusion criteria (13 listed)
- Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
- Patients with type 1 diabetes or other specific types of diabetes.
- Patients with severe organ dysfunction, defined as:
- Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients with known hypersensitivity to any drugs or materials used in the study protocol.
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 systemPerioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management. | Device | Hybrid closed-loop insulin delivery system |
| conventional insulin pumps combined with CGMPerioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management. | Device | Conventional insulin pump with CGM |
Primary outcome
CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
Time frame: Up to 28 days
The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
13 secondary outcomes
Time above range (TAR) >10.0 mmol/L
Time frame: Up to 28 days
Time above range (TAR) >20.0 mmol/L
Time frame: Up to 28 days
Time below range (TBR) <5.6 mmol/L
Time frame: Up to 28 days
Time below range (TBR) < 3.9 mmol/L
Time frame: Up to 28 days
Time below range (TBR) < 3.0 mmol/L
Time frame: Up to 28 days
Time below range (TBR) < 2.8 mmol/L
Time frame: Up to 28 days
CGM-measured Mean Glucose Level
Time frame: Up to 28 days
CGM-measured Glucose Standard Deviation (SD)
Time frame: Up to 28 days
CGM-Measured Glucose Coefficient of Variation (CV)
Time frame: Up to 28 days
CGM-Measured Glucose Risk Index (GRI)
Time frame: Up to 28 days
Insulin dose
Time frame: Up to 28 days
Preoperative optimization duration (days)
Time frame: Up to 28 days
Time in range (TIR) 4.4-10.0 mmol/L
Time frame: Up to 28 days
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 13 Aug 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.
Xia Li, MD, PhD principal investigator
Second Xiangya Hospial of Central South University
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 conventional insulin pumps combined with CGM in people with Type 2 Diabetes, run by Second Xiangya Hospital of Central South University 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 6 inclusion and 13 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 13 Aug 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. 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 Xia Li, MD, PhD (+86 13974885753, lixia2014@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM-measured Time in Range (TIR 5.6-10.0 mmol/L) (time frame: Up to 28 days). 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 13 Aug 2025.