Type 1 DiabetesNCT07403565

To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes.

A study testing Insulin Patch Pump System and Minimed 700 in people with Type 1 Diabetes and Type 2 Diabetes, run by Suzhou Hechun Medical Technology Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients will be enrolled and randomly assigned to either the test group or the control group for short-time intensive insulin therapy in inpatient setting. The test group will receive treatment with the Insulin Patch Pump System, while the control group will be treated with the Medtronic MMT-1805 insulin pump… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 1 Diabetes, Type 2 Diabetes
What is being tested?: Insulin Patch Pump System and Minimed 700
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 5 sitesChina
Study dates: 14 Jun 2025to 3 Dec 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age is ≥18 years and ≤ 75 years old, gender not restricted;
Body Mass Index (BMI) < 30 kg/m²;
Patients diagnosed as type 1 diabetes or type 2 diabetes according to WHO standards (1999), and requiring intensive insulin therapy;
HbA1c > 7.0% and ≤ 12.0%.

Who cannot join

Those who had used any of the following insulin secretagogues or incretin drugs 14 days prior to enrollment, including sulfonylurea drugs, glinide drugs, dipeptidyl peptidase IV inhibitors (DPP-4i), and glucagon-like peptide-1 receptor agonists (GLP-1RA), among which the weekly formulation of exenatide for GLP-1RA needs to be extended to 70 days prior to enrollment;
Pregnant or lactating women;
Patients with acute metabolic complications of diabetes (such as diabetic ketoacidosis, non-ketotic hyperosmolar coma, lactic acidosis, etc.) or with hyperglycemia who are receiving intravenous antibiotic treatment due to infection;
Within the 28 days prior to enrollment, there was a history of a severe hypoglycemic event (Grade 3 hypoglycemia: without a specific blood glucose threshold, involving severe events with changes in consciousness and/or physical condition, requiring assistance from others);
Include patients with other endocrine disorders that may cause abnormal blood sugar levels, such as Cushing's syndrome, primary aldosteronism, and endocrine gland tumors;
Patients with acute-stage cardiovascular and cerebrovascular diseases;

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Patients with a history of allergy to insulin, insulin pump adhesives, or subcutaneous infusion tubes;
For patients whose researchers have determined that there are adverse conditions in the skin area where the insulin pump is implanted (such as subcutaneous nodules, subcutaneous fat hyperplasia, subcutaneous fat atrophy, skin scarring, skin infection, skin edema, etc.) that affect the injection and absorption of the medication;
Within 14 days prior to enrollment, and during the trial period, the participant had used and planned to use systemic glucocorticoids (excluding inhalation, topical eye medication, or local application);
During the screening process, the laboratory test indicators must meet the following criteria: ① Liver function impairment: ALT or AST is greater than 3 times the upper limit of the normal value; ② Kidney function impairment: Serum creatinine is greater than 1.5 times the upper limit of the normal value.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Peking University First Hospital
Beijing, Beijing Municipality
Sun Yat-sen Memorial Hosipital,Sun Yat-sen University
Guangzhou, Guangdong
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong

Other trials in China

About this study

Official title: To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes: A Prospective, Randomized, Positive Parallel Controlled, Open-label, Multicenter, Non-inferiority Clinical Trial.

Read the detailed description

The efficacy and safety of the Insulin Patch Pump System for insulin infusion therapy in patients with diabetes are evaluated by comparing it with the MMT-1805 insulin pump (MiniMed 700). This clinical trial employs a prospective, randomized, active-controlled, open-label, multicenter, non-inferiority design.

On Day 0 (baseline), all participants maintain their pre-existing antidiabetic regimens to collect baseline glucose data. From Day 1 to Day 7, patients undergo a 7-day course of intensive insulin pump therapy. The test group receives treatment with the Insulin Patch Pump System, while the control group is treated with the Medtronic MMT-1805 insulin pump (MiniMed 700). During the intervention, participants receive standardized diabetic hospital meals and perform eight-point daily capillary blood glucose (BG) monitoring. Concurrently, continuous glucose monitoring (CGM) is maintained. Glycated albumin (GA) levels are assessed at baseline (Day 0) and post-treatment (Day 8).

Conditions: Type 1 Diabetes, Type 2 Diabetes
Being tested: Insulin Patch Pump System, Minimed 700
Keywords: Non-inferiority, diabetes, insulin patch pump
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin Patch Pump SystemDevice
patients who enrolled in this group use the Insulin Patch Pump System
Minimed 700Device
patients who enrolled in this group use Minimed 700

Study groups in NCT07403565
Study group	Role	What they receive
Insulin Patch Pump System	Experimental	patients who enrolled in this arm use the Insulin Patch Pump System Receives: Device: Insulin Patch Pump System
Minimed 700	Active comparator	patients who enrolled in this group use Minimed 700 Receives: Device: Minimed 700

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in mean blood glucose from baseline(Day 0) to Day 7
Measured: Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups

Secondary outcomes (14)

Change in mean preprandial blood glucose from baseline(Day 0) to Day 7
Measured: Compare the difference in the change of mean preprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
Change in mean 2-hour postprandial blood glucose from baseline(Day 0) to Day 7
Measured: Compare the difference in the change of mean 2-hour postprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
Change in postprandial glucose excursion (PPGE) from baseline(Day 0) to Day 7
Measured: Compare the difference in the change of postprandial glucose excursion (PPGE) from baseline (Day 0) to Day 7 between the two groups.
Time in Range (TIR) during the treatment period
Measured: Compare the difference in TIR between the two groups during the treatment period (Day 1 to Day 7).
Glucose coefficient of variation during the treatment period
Measured: Compare the difference in glucose coefficient of variation between the two groups during the treatment period (Day 1 to Day 7).
Change in glycated albumin (GA)
Measured: Compare the difference in changes in glycated albumin (GA) between the two groups from Day 0 to Day 8
Time Above Range (TAR) during the treatment period
Measured: Compare the difference in TAR between the two groups during the treatment period (Day 1 to Day 7)
Time Below Range (TBR) during the treatment period
Measured: Compare the difference in TBR between the two groups during the treatment period (Day 1 to Day 7)
Incidence of diabetic ketoacidosis (DKA) during the treatment period
Measured: Day 0 to Day 7
Device defect rate during the treatment period
Measured: Day 1 to Day 7
Local injection site reactions during the treatment period
Measured: Day 1 to Day 7
Occurrence of adverse events during the treatment period
Measured: Day 0 to Day 7
Device performance assessment scale
After completing the training, the investigators administered treatment using the device in accordance with the Instructions for Use. Upon completion of treatment, the investigators rated the device's performance across 11 dimensions, including Ease of device assembly/Ease of parameter configuration/Ease of consumable replacement/Product sealing integrity/Infusion smoothness/Adhesion stability/Battery life/Alarm reliability/Failure-free operation/User interface smoothness/Bluetooth Function and Connection Stability. Each item was scored on a 3-point scale (3 = excellent, 2 = satisfactory, 1 = poor), with higher scores indicating better performance.
Measured: Day 8
Patient satisfaction assessment scale
After treatment completion, subjects rated their satisfaction with the device's ease of use and operation across 5 dimensions, including Implantation Pain Satisfaction/Comfortable Satisfaction/Convenient Satisfaction/Blood Glucose Management Satisfaction/Treatment Satisfaction. Each item was scored on a 3-point scale (3 = excellent, 2 = satisfactory, 1 = poor), with higher scores indicating a more favorable outcome.
Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 20253 Dec 2025

First posted11 Feb 2026
Study start14 Jun 2025
Primary completion8 Nov 2025
Study completion3 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 1 DiabetesStudies 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: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07403565
Sponsor's protocol ID: 20250041-0002
Status last verified: Feb 2026
First submitted: 15 Dec 2025
Last updated: 11 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes: A Prospective, Randomized, Positive Parallel Controlled, Open-label, Multicenter, Non-inferiority Clinical Trial.
ClinicalTrials.gov ID: NCT07403565
Acronym / sponsor ID: 20250041-0002
Conditions: Type 1 Diabetes, Type 2 Diabetes
Keywords: Non-inferiority, diabetes, insulin patch pump
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Suzhou Hechun Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 Jun 2025 (actual)
Primary completion: 8 Nov 2025 (actual)
Study completion: 3 Dec 2025 (actual)
First posted: 11 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin Patch Pump System	Experimental	Device: Insulin Patch Pump Systempatients who enrolled in this arm use the Insulin Patch Pump System
Minimed 700	Active comparator	Device: Minimed 700patients who enrolled in this group use Minimed 700

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age is ≥18 years and ≤ 75 years old, gender not restricted;
Body Mass Index (BMI) < 30 kg/m²;
Patients diagnosed as type 1 diabetes or type 2 diabetes according to WHO standards (1999), and requiring intensive insulin therapy;
HbA1c > 7.0% and ≤ 12.0%.

Key exclusion criteria (10 listed)

Those who had used any of the following insulin secretagogues or incretin drugs 14 days prior to enrollment, including sulfonylurea drugs, glinide drugs, dipeptidyl peptidase IV inhibitors (DPP-4i), and glucagon-like peptide-1 receptor agonists (GLP-1RA), among which the weekly formulation of exenatide for GLP-1RA needs to be extended to 70 days prior to enrollment;
Pregnant or lactating women;
Patients with acute metabolic complications of diabetes (such as diabetic ketoacidosis, non-ketotic hyperosmolar coma, lactic acidosis, etc.) or with hyperglycemia who are receiving intravenous antibiotic treatment due to infection;
Within the 28 days prior to enrollment, there was a history of a severe hypoglycemic event (Grade 3 hypoglycemia: without a specific blood glucose threshold, involving severe events with changes in consciousness and/or physical condition, requiring assistance from others);
Include patients with other endocrine disorders that may cause abnormal blood sugar levels, such as Cushing's syndrome, primary aldosteronism, and endocrine gland tumors;

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
Insulin Patch Pump Systempatients who enrolled in this group use the Insulin Patch Pump System	Device	Insulin Patch Pump System
Minimed 700patients who enrolled in this group use Minimed 700	Device	Minimed 700

Primary outcome

Change in mean blood glucose from baseline(Day 0) to Day 7
Time frame: Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups

14 secondary outcomes

Change in mean preprandial blood glucose from baseline(Day 0) to Day 7
Time frame: Compare the difference in the change of mean preprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
Change in mean 2-hour postprandial blood glucose from baseline(Day 0) to Day 7
Time frame: Compare the difference in the change of mean 2-hour postprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
Change in postprandial glucose excursion (PPGE) from baseline(Day 0) to Day 7
Time frame: Compare the difference in the change of postprandial glucose excursion (PPGE) from baseline (Day 0) to Day 7 between the two groups.
Time in Range (TIR) during the treatment period
Time frame: Compare the difference in TIR between the two groups during the treatment period (Day 1 to Day 7).
Glucose coefficient of variation during the treatment period
Time frame: Compare the difference in glucose coefficient of variation between the two groups during the treatment period (Day 1 to Day 7).
Change in glycated albumin (GA)
Time frame: Compare the difference in changes in glycated albumin (GA) between the two groups from Day 0 to Day 8
Time Above Range (TAR) during the treatment period
Time frame: Compare the difference in TAR between the two groups during the treatment period (Day 1 to Day 7)
Time Below Range (TBR) during the treatment period
Time frame: Compare the difference in TBR between the two groups during the treatment period (Day 1 to Day 7)
Incidence of diabetic ketoacidosis (DKA) during the treatment period
Time frame: Day 0 to Day 7
Device defect rate during the treatment period
Time frame: Day 1 to Day 7
Local injection site reactions during the treatment period
Time frame: Day 1 to Day 7
Occurrence of adverse events during the treatment period
Time frame: Day 0 to Day 7
Device performance assessment scale
Time frame: Day 8
Patient satisfaction assessment scale
Time frame: Day 8

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 11 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
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Metastatic Colorectal Cancer
Not yet recruiting
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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.

Xiaohui Guo, Doctor principal investigator

Peking University First Hospital

Zhifeng Cheng, Doctor principal investigator

The Fourth Hospital of Harbin Medical University

Meng Ren, Doctor principal investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Patch Pump System and Minimed 700 in people with Type 1 Diabetes and Type 2 Diabetes, run by Suzhou Hechun Medical Technology Co., Ltd. at 5 sites 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 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Change in mean blood glucose from baseline(Day 0) to Day 7 (time frame: Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07403565.

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 11 Feb 2026.