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

NCT ID: NCT05726461

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-11
• Study Completion Date: 2024-09-30

Brief Summary

This is a 26-week randomized, free-living, open-label, two-arm, two-phase, crossover trial. Participants will receive two interventions at different phases, including the Android artificial pancreas system(AndroidAPS-rt-CGM) and sensor-augment pump(SAP), and use marketed rapid-acting insulin analogs (insulin Aspart, insulin Lispro, or insulin Glulisine) normally used in their usual clinical care. The safety and efficacy of AndroidAPS-rt-CGM and SAP in adult T1DM with suboptimal glycemic control will be compared to explore whether the use of AndroidAPS-rt-CGM in adult T1DM with suboptimal glycemic control will be associated with better glycemic control with no increased hypoglycemia.

Detailed Description

All participants will be free to live during the study. Each intervention phase is 12 weeks, preceded by a 2-week training period and separated by a 2-week washout period. During the training period, eligible participants will be trained to use the study rt-CGM and insulin pump and randomly assigned 1:1 to two treatment sequences after the training period. In Sequence A, patients use AndroidAPS-rt-CGM for the first intervention period (phase 1) and SAP for the second intervention period (phase 2); in Sequence B, patients use SAP for Phase 1 and AndroidAPS-rt-CGM for Phase 2. Participants who enter sequences A and B will be trained to use the study devices running in automated insulin delivery(AID) mode on the first day of phase 1 and phase 2, respectively. AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone. The participants will use the study patch pump and rt-CGM, but the AndroidAPS algorithm and advanced features will not be allowed during the SAP intervention period. During the washout period, participants will continue using the study insulin pump with their standard settings, but the study rt-CGM will be replaced by daily self-monitoring of fingerstick glucose. The primary endpoint is time in range (3.9-10.0 mmol/L) derived from CGM. The main secondary endpoints include the percentage of sensor glucose values below, within, and above the target range; mean sensor glucose value; measures of glycemic variability, and centralized HbA1c. Safety endpoints mainly include the frequency of hypoglycemia events, diabetic ketoacidosis, and other serious adverse events.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AndroidAPS-rt-CGM

1\) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone

Group Type: EXPERIMENTAL

AndroidAPS-rt-CGM;

Intervention Type: DEVICE

Insulin therapy (aspart, lispro or glulisine) with AndroidAPS-rt-CGM.AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone.

sensor augmented pump(SAP)

SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Group Type: ACTIVE_COMPARATOR

sensor augmented pump(SAP);

Intervention Type: DEVICE

Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Interventions

AndroidAPS-rt-CGM;

Insulin therapy (aspart, lispro or glulisine) with AndroidAPS-rt-CGM.AndroidAPS-rt-CGM consists of three components:1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone.

Intervention Type: DEVICE

sensor augmented pump(SAP);

Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Jinhua Yan

Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinhua Yan, phD

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Wen Xu, phD,MD

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Jinhua Yan

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinhua Yan, phD

Role: CONTACT

yanjh79@163.com

+8613929589959

Wen Xu, phD,MD

Role: CONTACT

xwen@mail.sysu.edu.cn

020-85253000

Facility Contacts

Jinhua Yan, phD

Role: primary

yanjh79@163.com

+8613929589959

Wen Xu, phD

Role: backup

xwen@mail.sysu.edu.cn

02085253000

References

Huang Q, Ni Y, Lei M, Ling P, Yan J, Guo X, Yang D, Wang C. Experiences and opinions of adults with type 1 diabetes on the android-based open-source closed-loop system in China: a qualitative study. BMJ Open. 2025 Jan 15;15(1):e094333. doi: 10.1136/bmjopen-2024-094333.

Reference Type: DERIVED

PMID: 39819904 (View on PubMed)

Lei M, Lin B, Ling P, Liu Z, Yang D, Deng H, Yang X, Lv J, Xu W, Yan J. Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial. BMJ Open. 2023 Aug 9;13(8):e073263. doi: 10.1136/bmjopen-2023-073263.

Reference Type: DERIVED

PMID: 37558445 (View on PubMed)

Other Identifiers

MLei

Identifier Type: -

Identifier Source: org_study_id