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Diabetes MellitusNCT05726461

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

A study testing AndroidAPS-rt-CGM; and sensor augmented pump(SAP); in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AndroidAPS-rt-CGM; and sensor augmented pump(SAP);
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
11 Feb 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country.

Jinhua Yan, phD contact

+8613929589959

yanjh79@163.com

Wen Xu, phD,MD contact

020-85253000

xwen@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Jinhua Yan

    Guangzhou, Guangdong, 510630

    Jinhua Yan, phD, +8613929589959, yanjh79@163.com

    Wen Xu, phD, 02085253000, xwen@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Read the 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.

Being tested
AndroidAPS-rt-CGM;, sensor augmented pump(SAP);
Keywords
Type 1 diabetes mellitus;, Artificial pancreas system;, Do-it-yourself artificial pancreas system;, Automated insulin delivery;, Hybrid closed loop;, Adult, AndroidAPS
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05726461
Study groupRoleWhat they receive
AndroidAPS-rt-CGMExperimental1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone
Receives: Device: AndroidAPS-rt-CGM;
sensor augmented pump(SAP)Active comparatorSAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.
Receives: Device: sensor augmented pump(SAP);

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during the last 2 weeks of each phase

Secondary outcomes (12)

  1. Glycosylated Hemoglobin A1c(HbA1c)

    centralized HbA1c will be measured on the last day of each phase

    Measured: on the last day of each phase

  2. Time in target range(TIT)

    TIT(3.9-7.8 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  3. Time above range(TAR)

    TAR(> 10.0 mmol/L and > 13.9 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  4. Time below range(TBR)

    TBR(< 3.9 mmol/L and <3.0 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  5. Mean blood glucose value(MBG)

    MBG derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  6. Standard deviation(SD)

    SD derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  7. Coefficient of variation(CV)

    CV derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  8. Mean amplitude of glucose excursions(MAGE)

    MAGE derived from CGM will be collected during the last 2 weeks of each phase.

    Measured: during the last 2 weeks of each phase.

  9. the Chinese version of Hypoglycemia Fear Survey II-Worry Scale(HFS-II)

    The Chinese version of Hypoglycemia Fear Survey II- Worry Scale is used to evaluate the psychological status of diabetic patients. Change in Hypoglycemia Fear Scale (HFS) score will be assessed in week 12 and week 26 adjusted for baseline(week 0 and week 14). These validated surveys include 18 questions to measure hypoglycemia-related anxiety and fear. Each item is rated on a 5-point Likert scale from 0(never related) to 4(very related). "Never relative" scores 1, " and "very related" scores 4. Patients with higher scores are considered with more anxiety and fear of hypoglycemia. The change in HFS-II will be assessed in week 12 and week 26 adjusted for baseline(weeks 0 and 14).

    Measured: in week 0 ,week 12, week 14, and week 26

  10. Frequency of hypoglycemia events

    Level 1 is defined as sensor glucose ≤3.9mmol/L;level 2 is defined as sensor glucose ≤3.0mmol/L; level 3 is defined as hypoglycemia accompanied by severe cognitive impairment requiring the assistance of another individual to administer rescue therapy.

    Measured: 12 weeks for each arm of the crossover

  11. Frequency of diabetic ketoacidosis (DKA)

    DKA can be diagnosed when the following three points are met: 1)plasma glucose level ≥13.9mmol/L;2)pH<7.3 or bicarbonate <18 mmol/L;3)serum ketone ≥3mmol/L or urine ketone≥2+.

    Measured: 12 weeks for each arm of the crossover

  12. Frequency of serious adverse events about device

    Serious adverse device effect(ADE) is defined as an event related to the use of the study device which is fatal or life-threatening, resulting in persistent or substantial disability, or requires (or prolonged) hospitalization.

    Measured: 12 weeks for each arm of the crossover

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start11 Feb 2023
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726461
Sponsor's protocol ID
MLei
Status last verified
Jul 2023
First submitted
18 Jan 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39819904

  • 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.

    PubMed 37558445

Questions about this trial

What is this clinical trial studying?

A study testing AndroidAPS-rt-CGM; and sensor augmented pump(SAP); in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinhua Yan, phD (+8613929589959, yanjh79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range(TIR) (time frame: during the last 2 weeks of each phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726461, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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