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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| sensor augmented pump(SAP) | Active Comparator | SAP includes only Equil® insulin patch pump and AiDEX G7 continuous glucose monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin A1c(HbA1c) | centralized HbA1c will be measured on the last day of each phase | on the last day of each phase |
| 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. |
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Inclusion Criteria:
Prior to this study:
Exclusion Criteria:
Prior to this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinhua Yan, phD | Contact | +8613929589959 | yanjh79@163.com | |
| Wen Xu, phD,MD | Contact | 020-85253000 | xwen@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Yan | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39819904 | Derived | 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. | |
| 37558445 | Derived | 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. |
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|
| 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. |
|
| during the last 2 weeks of each phase. |
| 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. | during the last 2 weeks of each phase. |
| 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. | during the last 2 weeks of each phase. |
| Mean blood glucose value(MBG) | 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) | 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) | 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) | MAGE derived from CGM will be collected during the last 2 weeks of each phase. | during the last 2 weeks of each phase. |
| 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). | in week 0 ,week 12, week 14, and week 26 |
| 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. | 12 weeks for each arm of the crossover |
| 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+. | 12 weeks for each arm of the crossover |
| 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. | 12 weeks for each arm of the crossover |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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