Using an Android artificial pancreas system for adults with Type 1 diabetes in China

Efficacy and Safety of Android Artificial Pancreas System Use at Home Among Type 1 Diabetes Mellitus Adults in China: Protocol of a 26-Week, Free-Living, Randomized, Open-Label, Two-Arm, Two-Phase, Crossover Trial

This study is testing whether an Android artificial pancreas can help adults with Type 1 diabetes manage their blood sugar better than a traditional insulin pump.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05726461 on ClinicalTrials.gov

What this trial studies

This clinical trial is a 26-week randomized, open-label, two-arm, two-phase, crossover trial designed to evaluate the efficacy and safety of the Android artificial pancreas system (AndroidAPS-rt-CGM) compared to a sensor-augmented pump (SAP) in adults with Type 1 diabetes mellitus (T1DM) who have suboptimal glycemic control. Participants will undergo two 12-week intervention phases, separated by a washout period, during which they will be trained to use the devices and monitor their glucose levels. The primary endpoint is the time in range for glucose levels, while secondary endpoints include the percentage of sensor glucose values in various ranges. The goal is to determine if the AndroidAPS-rt-CGM can provide better glycemic control without increasing the risk of hypoglycemia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with Type 1 diabetes diagnosed for at least one year and experiencing suboptimal glycemic control.

Not a fit: Patients with severe acute or chronic complications of diabetes or those who have recently used closed-loop therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glycemic control for adults with Type 1 diabetes, enhancing their quality of life and reducing complications.

How similar studies have performed: Other studies have shown promise with similar automated insulin delivery systems, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Prior to this study:

1. Type 1 diabetes mellitus(T1DM) was diagnosed by an endocrinologist for at least one year.
2. Aged from 18 to 75 years.
3. HbA1c was 7.0% \~ 11%.
4. on multiple daily injection(MDI) or insulin pump therapy for ≥3 months with less than 20% insulin dose changes.
5. The total daily dose(TDD) were≥0.3 u/kg /day, and the basal rate was ≥0.05 u/hour.
6. Regular self-monitoring of blood glucose (≥3 times per day) for ≥2 months.
7. Lived with an adult willing to care for the subject during the study.
8. Women of childbearing age are willing to use appropriate contraceptive measures.
9. Willing to follow the research protocol.
10. Have daily access to a Wi-Fi network.

Exclusion Criteria:

Prior to this study:

1. Severe acute or chronic complications of diabetes mellitus.
2. Frequent severe hypoglycemia in the past three months.
3. Patients who have used closed-loop therapy in the last two months (excluding those who have recently used CGM) and those participating in other studies.
4. Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal).
5. Moderate to severe renal impairment (eGFR\<60ml/min/1.73m2).
6. Clinically significant heart disease.
7. Pregnant or planning pregnancy.
8. Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks.
9. Frequent acetaminophen, drug abuse, and excessive drinking.
10. Known allergy to medical-grade adhesives or CGM and its affiliated components.
11. Severe visual or hearing impairment.
12. Severe skin disease at the site of sensor implantation.
13. Plan to undergo elective surgery requiring general anesthesia during the study.
14. Eating disorders such as anorexia or bulimia.
15. Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.

Where this trial is running

Guangzhou, Guangdong

• Jinhua Yan — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jinhua Yan, phD — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Jinhua Yan, phD

Conditions Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Type 1 diabetes mellitus