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Patch pump could simplify diabetes care

NCT ID NCT07403565

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new insulin patch pump in 161 adults with type 1 or type 2 diabetes who needed intensive insulin therapy. Participants used either the new patch pump or a standard pump for 7 days in a hospital. Researchers measured changes in average blood sugar levels to see if the patch pump worked as well as the standard one.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin Patch Pump System (a wearable device that delivers insulin)
What this could lead to
If successful, this could offer people with diabetes a more convenient and effective way to manage their blood sugar with a patch pump instead of a traditional pump.
What could go wrong
This was a short, 7-day inpatient study with only 161 participants, so long-term benefits and real-world use are not yet proven. The device may not work as well for everyone or could have technical issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

161 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age is ≥18 years and ≤ 75 years old, gender not restricted; 2. Body Mass Index (BMI) \< 30 kg/m²; 3. Patients diagnosed as type 1 diabetes or type 2 diabetes according to WHO standards (1999), and requiring intensive insulin therapy; 4. HbA1c \> 7.0% and ≤ 12.0%. Exclusion Criteria: 1. 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; 2. Pregnant or lactating women; 3. 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; 4. 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); 5. Include patients with other endocrine disorders that may cause abnormal blood sugar levels, such as Cushing's syndrome, primary aldosteronism, and endocrine gland tumors; 6. Patients with acute-stage cardiovascular and cerebrovascular diseases; 7. Patients with a history of allergy to insulin, insulin pump adhesives, or subcutaneous infusion tubes; 8. 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; 9. 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); 10. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

  • Sir Run Run Hospital, Nanjing Medical University

    Nanjing, Jiangsu, China

  • Sun Yat-sen Memorial Hosipital,Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, China

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