NCT05726461

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

February 11, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

January 18, 2023

Last Update Submit

July 25, 2023

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Keywords

Type 1 diabetes mellitus;Artificial pancreas system;Do-it-yourself artificial pancreas system;Automated insulin delivery;Hybrid closed loop;AdultAndroidAPS

Outcome Measures

Primary Outcomes (1)

  • Time in range(TIR)

    TIR(3.9-10.0 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

    during the last 2 weeks of each phase

Secondary Outcomes (12)

  • Glycosylated Hemoglobin A1c(HbA1c)

    on the last day of each phase

  • Time in target range(TIT)

    during the last 2 weeks of each phase.

  • Time above range(TAR)

    during the last 2 weeks of each phase.

  • Time below range(TBR)

    during the last 2 weeks of each phase.

  • Mean blood glucose value(MBG)

    during the last 2 weeks of each phase.

  • +7 more secondary outcomes

Study Arms (2)

AndroidAPS-rt-CGM

EXPERIMENTAL

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

Device: AndroidAPS-rt-CGM;

sensor augmented pump(SAP)

ACTIVE COMPARATOR

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

Device: sensor augmented pump(SAP);

Interventions

AndroidAPS-rt-CGM;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.

AndroidAPS-rt-CGM
sensor augmented pump(SAP);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.

sensor augmented pump(SAP)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior to this study:
  • Severe acute or chronic complications of diabetes mellitus.
  • Frequent severe hypoglycemia in the past three months.
  • 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.
  • Abnormal liver function (ALT was 2.5 times higher than the upper limit of normal).
  • Moderate to severe renal impairment (eGFR\<60ml/min/1.73m2).
  • Clinically significant heart disease.
  • Pregnant or planning pregnancy.
  • Used drugs that can interfere with glucose metabolism (e.g., exogenous glucocorticoids, nonselective beta-blockers, monoamine oxidase inhibitors) in the past eight weeks.
  • Frequent acetaminophen, drug abuse, and excessive drinking.
  • Known allergy to medical-grade adhesives or CGM and its affiliated components.
  • Severe visual or hearing impairment.
  • Severe skin disease at the site of sensor implantation.
  • Plan to undergo elective surgery requiring general anesthesia during the study.
  • Eating disorders such as anorexia or bulimia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinhua Yan

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39819904DERIVED

  • 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.

    PMID: 37558445DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Jinhua Yan, phD

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

  • Wen Xu, phD,MD

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhua Yan, phD

CONTACT

+8613929589959yanjh79@163.com

Wen Xu, phD,MD

CONTACT

020-85253000xwen@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 14, 2023

Study Start

February 11, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)