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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.

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.

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 (MiniMed 700). The treatment period will last 7 days, during which blood glucose monitoring will be conducted in both groups.

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).

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 groupRoleWhat they receive
Insulin Patch Pump SystemExperimentalpatients who enrolled in this arm use the Insulin Patch Pump System
Receives: Device: Insulin Patch Pump System
Minimed 700Active comparatorpatients 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  4. 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).

  5. 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).

  6. 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

  7. 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)

  8. 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)

  9. Incidence of diabetic ketoacidosis (DKA) during the treatment period

    Measured: Day 0 to Day 7

  10. Device defect rate during the treatment period

    Measured: Day 1 to Day 7

  11. Local injection site reactions during the treatment period

    Measured: Day 1 to Day 7

  12. Occurrence of adverse events during the treatment period

    Measured: Day 0 to Day 7

  13. 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

  14. 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.

  1. First posted11 Feb 2026
  2. Study start14 Jun 2025
  3. Primary completion8 Nov 2025
  4. Study completion3 Dec 2025

Resources

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

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.

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