- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05726461
Efficacy and Safety of Android Artificial Pancreas System in Adult Patients With Type 1 Diabetes Mellitus in China
July 25, 2023 updated by: Jinhua Yan, Third Affiliated Hospital, Sun Yat-Sen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinhua Yan, phD
- Phone Number: +8613929589959
- Email: yanjh79@163.com
Study Contact Backup
- Name: Wen Xu, phD,MD
- Phone Number: 020-85253000
- Email: xwen@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510630
- Recruiting
- Jinhua Yan
-
Contact:
- Jinhua Yan, phD
- Phone Number: +8613929589959
- Email: yanjh79@163.com
-
Contact:
- Wen Xu, phD
- Phone Number: 02085253000
- Email: xwen@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
- Other physical or psychological conditions deemed inappropriate for inclusion by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AndroidAPS-rt-CGM
1) AiDEX G7 continuous glucose monitoring (an rt-CGM);2) Equil® insulin patch pump;3) AndroidAPS algorithm implemented in Android smartphone
|
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.
|
Active Comparator: sensor augmented pump(SAP)
SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.
|
Insulin therapy (aspart, lispro or glulisine) with sensor augmented pump(SAP).SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in range(TIR)
Time Frame: during the last 2 weeks of each phase
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Chinese version of Hypoglycemia Fear Survey II-Worry Scale(HFS-II)
Time Frame: in week 0 ,week 12, week 14, and week 26
|
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).
|
in week 0 ,week 12, week 14, and week 26
|
Frequency of hypoglycemia events
Time Frame: 12 weeks for each arm of the crossover
|
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.
|
12 weeks for each arm of the crossover
|
Frequency of diabetic ketoacidosis (DKA)
Time Frame: 12 weeks for each arm of the crossover
|
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+.
|
12 weeks for each arm of the crossover
|
Frequency of serious adverse events about device
Time Frame: 12 weeks for each arm of the crossover
|
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.
|
12 weeks for each arm of the crossover
|
Glycosylated Hemoglobin A1c(HbA1c)
Time Frame: on the last day of each phase
|
centralized HbA1c will be measured on the last day of each phase
|
on the last day of each phase
|
Time in target range(TIT)
Time Frame: during the last 2 weeks of each phase.
|
TIT(3.9-7.8 mmol/l) derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Time above range(TAR)
Time Frame: during the last 2 weeks of each phase.
|
TAR(> 10.0 mmol/L and > 13.9 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Time below range(TBR)
Time Frame: during the last 2 weeks of each phase.
|
TBR(< 3.9 mmol/L and <3.0 mmol/L) derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Mean blood glucose value(MBG)
Time Frame: during the last 2 weeks of each phase.
|
MBG derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Standard deviation(SD)
Time Frame: during the last 2 weeks of each phase.
|
SD derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Coefficient of variation(CV)
Time Frame: during the last 2 weeks of each phase.
|
CV derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Mean amplitude of glucose excursions(MAGE)
Time Frame: during the last 2 weeks of each phase.
|
MAGE derived from CGM will be collected during the last 2 weeks of each phase.
|
during the last 2 weeks of each phase.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jinhua Yan, phD, Third Affiliated Hospital, Sun Yat-Sen University
- Principal Investigator: Wen Xu, phD,MD, Third Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
January 18, 2023
First Submitted That Met QC Criteria
February 12, 2023
First Posted (Actual)
February 14, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MLei
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glucose Metabolism Disorders
-
University of AberdeenCompletedMetabolism Disorder, GlucoseUnited Kingdom
-
Columbia UniversityCompletedMetabolism Disorder, GlucoseUnited States
-
University of LeipzigInstitut für Gesundheits- und Praxismanagement GmbHWithdrawn
-
Purdue UniversityAlmond Board of CaliforniaActive, not recruitingGlucose Intolerance | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
University of South CarolinaCompletedPhysical Activity | Sedentary Lifestyle | Metabolism Disorder, GlucoseUnited States
-
DLR German Aerospace CenterCompletedGlucose Metabolism Disorders | Local Glucose Uptake
-
University of Missouri-ColumbiaCompletedGlucose | Blood Sugar; High | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Solvay PharmaceuticalsTerminatedDyslipidemia | Glucose Metabolism DisorderPoland, Croatia, Finland, France, Germany, Netherlands, Romania, Ukraine
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderPoland, Ukraine, United Kingdom
-
Azienda Ospedaliero, Universitaria PisanaCompletedPregnancy Related | Maternal-Fetal Relations | Metabolism Disorder, GlucoseItaly
Clinical Trials on AndroidAPS-rt-CGM;
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingType 1 Diabetes MellitusChina
-
DexCom, Inc.Jaeb Center for Health ResearchCompletedDiabetes MellitusUnited States, Canada
-
Walter Reed National Military Medical CenterDexCom, Inc.CompletedImpaired Glucose Tolerance | Pre-diabetesUnited States
-
Pusan National University HospitalUnknownObesity | Prediabetic State | Continuous Glucose MonitoringKorea, Republic of
-
Nicole Ehrhardt, MDDexCom, Inc.CompletedObesity | Diabetes Mellitus, Type 2 | PreDiabetesUnited States
-
Children's Hospital of Eastern OntarioJuvenile Diabetes Research Foundation; Canadian Clinical Trial NetworkCompleted
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy | Type 1 Diabetes | Hypoglycemia UnawarenessUnited States
-
Jaeb Center for Health ResearchDexCom, Inc.Completed
-
University Hospital PadovaBoston Children's Hospital; University of PadovaCompletedInfant, Very Low Birth Weight | Neonatal HypoglycemiaUnited States, Italy
-
University of Ljubljana, Faculty of MedicineCompleted