Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Feb 12, 2023

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ClinConnect Summary

This clinical trial is studying a new system called the Android Artificial Pancreas (AndroidAPS) to see if it helps adults with Type 1 diabetes manage their blood sugar better. Participants will use either the AndroidAPS or another device called a sensor-augmented pump (SAP) over a 26-week period. This research aims to find out if the AndroidAPS leads to better blood sugar control without causing more low blood sugar episodes, which can be dangerous.

To be eligible for this trial, you must be between 18 and 75 years old, have been diagnosed with Type 1 diabetes for at least a year, and have blood sugar levels (measured by a test called HbA1c) between 7.0% and 11%. You should also be using insulin therapy regularly, either through daily injections or an insulin pump, and have been monitoring your blood sugar at least three times a day. If you decide to participate, you’ll have access to Wi-Fi and need to follow the study's guidelines. This trial is currently looking for participants, so if this sounds like you or someone you know, it might be worth considering!

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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.