Type 2 Diabetes Mellitus (T2DM)NCT07314749
2025 Hypoglycemia Early-Warning and Physician-Nurse Collaborative Management Trial in Type 2 Diabetes
A study testing Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System in people with Type 2 Diabetes Mellitus (T2DM), run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this clinical study is to learn whether a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System can reduce hypoglycemia and improve glycemic control in hospitalized adults with type 2 diabetes receiving intensive insulin pump therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,255 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 20 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus.
- Age 18 years or older.
- Hospitalized for 3 days or longer.
- Receiving continuous subcutaneous insulin infusion (CSII) therapy during hospitalization.
Who cannot join
- Acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state).
- Severe cardiovascular or cerebrovascular disease, hepatic dysfunction, or renal dysfunction.
- Malignant tumors.
- Severe cognitive impairment or psychiatric disorders that prevent cooperation.
- Premature discontinuation of CSII therapy due to non-glycemic reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Physician-Nurse Intervention With An Intelligent System for Hypoglycemia in Type 2 Diabetes Patients
The goal of this clinical study is to learn whether a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System can reduce hypoglycemia and improve glycemic control in hospitalized adults with type 2 diabetes receiving intensive insulin pump therapy. The study also aims to understand how risk-stratified management influences the time needed to reach glycemic targets.
The main questions this study aims to answer are:
Read more
- Does the physician-nurse collaborative intervention reduce the incidence of hypoglycemia, particularly level 2 and symptomatic hypoglycemia?
- Does this intervention help patients reach their glycemic targets sooner during intensive insulin pump therapy?
- What differences in outcomes are observed between patients classified as high-risk and low-risk by the Intelligent Hypoglycemia Risk Early-Warning System?
Participants will:
- Receive either standard insulin pump therapy alone or insulin pump therapy combined with the physician-nurse collaborative intervention
- Undergo hypoglycemia risk assessment using the Intelligent Early-Warning System
- Receive individualized insulin dose adjustments, intensified glucose monitoring, and tailored hypoglycemia education based on their risk category
- Be monitored for hypoglycemic events and time to achieve glycemic targets during hospitalization This study will compare the collaborative intervention with standard care to evaluate its effectiveness in preventing hypoglycemia and accelerating glycemic stabilization among hospitalized patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System, Usual Care
- Keywords
- Hypoglycemia, Intensive Insulin Therapy, Physician-nurse collaboration, Risk early-warning system, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning SystemBehavioural
Participants in this arm will receive standard insulin pump therapy combined with a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System. The intervention includes individualized insulin dose adjustment, intensified glucose monitoring, risk-stratified hypoglycemia prevention strategies, targeted education, and nurse follow-up based on real-time risk alerts.
Usual CareOther
Participants in this arm will receive standard insulin pump therapy and usual nursing care according to routine hospital practice, without the use of the Intelligent Hypoglycemia Risk Early-Warning System or the physician-nurse collaborative intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System |
| Control Group | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypoglycemia
The proportion of participants experiencing hypoglycemia, defined as blood glucose < 3.9 mmol/L. Hypoglycemia will be further classified into level 1, level 2, level 3, symptomatic, and asymptomatic categories based on international clinical criteria.
Measured: From the date of randomization until hospital discharge, assessed up to 14 days.
Secondary outcomes (1)
Time to Glycemic Target
Time required for participants to reach predefined glycemic targets during insulin pump therapy. Glycemic targets are defined as fasting blood glucose 4.4-7.0 mmol/L and 2-hour postprandial glucose < 10.0 mmol/L.
Measured: From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2023
- Primary completion5 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314749
- Sponsor's protocol ID
- MR-44-25-024286
- Other IDs
- 2025A1515012706, A2024530, YHJH202404, 72204277, YJYZ202304
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive personal health information and is restricted by institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Nurse Intervention With An Intelligent System for Hypoglycemia in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT07314749
- Acronym / sponsor ID
- MR-44-25-024286
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Hypoglycemia, Intensive Insulin Therapy, Physician-nurse collaboration, Risk early-warning system, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 2 Jan 2026 (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.
The goal of this clinical study is to learn whether a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System can reduce hypoglycemia and improve glycemic control in hospitalized adults with type 2 diabetes receiving intensive insulin pump therapy. The study also aims to understand how risk-stratified management influences the time needed to reach glycemic targets.
The main questions this study aims to answer are:
- Does the physician-nurse collaborative intervention reduce the incidence of hypoglycemia, particularly level 2 and symptomatic hypoglycemia?
- Does this intervention help patients reach their glycemic targets sooner during intensive insulin pump therapy?
- What differences in outcomes are observed between patients classified as high-risk and low-risk by the Intelligent Hypoglycemia Risk Early-Warning System?
Participants will:
- Receive either standard insulin pump therapy alone or insulin pump therapy combined with the physician-nurse collaborative intervention
- Undergo hypoglycemia risk assessment using the Intelligent Early-Warning System
- Receive individualized insulin dose adjustments, intensified glucose monitoring, and tailored hypoglycemia education based on their risk category
- Be monitored for hypoglycemic events and time to achieve glycemic targets during hospitalization This study will compare the collaborative intervention with standard care to evaluate its effectiveness in preventing hypoglycemia and accelerating glycemic stabilization among hospitalized patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System |
| Control Group | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes mellitus.
- Age 18 years or older.
- Hospitalized for 3 days or longer.
- Receiving continuous subcutaneous insulin infusion (CSII) therapy during hospitalization.
Key exclusion criteria (5 listed)
- Acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state).
- Severe cardiovascular or cerebrovascular disease, hepatic dysfunction, or renal dysfunction.
- Malignant tumors.
- Severe cognitive impairment or psychiatric disorders that prevent cooperation.
- Premature discontinuation of CSII therapy due to non-glycemic reasons.
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 |
|---|---|---|
| Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning SystemParticipants in this arm will receive standard insulin pump therapy combined with a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System. The intervention includes individualized insulin dose adjustment, intensified glucose monitoring, risk-stratified hypoglycemia prevention strategies, targeted education, and nurse follow-up based on real-time risk alerts. | Behavioural | Intervention Group |
| Usual CareParticipants in this arm will receive standard insulin pump therapy and usual nursing care according to routine hospital practice, without the use of the Intelligent Hypoglycemia Risk Early-Warning System or the physician-nurse collaborative intervention. | Other | Control Group |
Primary outcome
Incidence of Hypoglycemia
Time frame: From the date of randomization until hospital discharge, assessed up to 14 days.
The proportion of participants experiencing hypoglycemia, defined as blood glucose < 3.9 mmol/L. Hypoglycemia will be further classified into level 1, level 2, level 3, symptomatic, and asymptomatic categories based on international clinical criteria.
1 secondary outcome
Time to Glycemic Target
Time frame: From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.
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 2 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive personal health information and is restricted by institutional and ethical requirements.
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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 Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System in people with Type 2 Diabetes Mellitus (T2DM), run by Third Affiliated Hospital, Sun Yat-Sen 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 4 inclusion and 5 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 2 Jan 2026. 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?
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?
Incidence of Hypoglycemia (time frame: From the date of randomization until hospital discharge, assessed up to 14 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 2 Jan 2026.