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

NCT05726461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jinhua Yan, phD · Third Affiliated Hospital, Sun Yat-Sen University

  • Wen Xu, phD,MD · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-11
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726461 on ClinicalTrials.gov