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Abstract

Background/purpose:

The artificial pancreas system is among the most advanced devices for blood glucose management and is known to improve patients’ glycated hemoglobin levels and time spent within the target glucose range. However, the use of an artificial pancreas in children with type 1 diabetes (T1D) in China has not yet been reported.

Methods:

A retrospective study was conducted involving patients diagnosed with T1D who used a do-it-yourself artificial pancreas system (DIYAPS). The main inclusion criteria were as follows: T1D diagnosis, age between 3 and 18 years, usage of an insulin pump, and continuous glucose monitoring records for at least 3 months. The exclusion criterion was any comorbid conditions that could interfere with the study. The primary outcomes measured were changes in hemoglobin A1c (HbA1c) and time in range (TIR) before and after the DIYAPS was used.

Results:

A total of 41 people were included in the study, including 21 males and 20 females, with a mean age of 9.4 years (standard deviation: 2.9 years), a median duration of T1D of 1.5 years (1.1–2.3), and a median duration of insulin pump use of 1.1 years (0.8–1.7). Compared with the baseline period (pre-DIYAPS), after using a DIYAPS, the TIR increased from 72.4% (57.9–82.4) to 80.8% (73.6–87.5; p < 0.01), the TAR (>10 mmol/L) decreased from 16.0% (8.2–21.2) to 8.8% (5.2–14.4; p < 0.01), the fasting blood glucose decreased from 8.2 mmol/L (7.2–9.4) to 6.7 mmol/L (6.3–7.6; p < 0.01), and the HbA1c decreased from 6.6% (6.1–7.6) to 6.3% (5.9–6.9; p < 0.05). No diabetic ketoacidosis, severe hypoglycemia, or other adverse events occurred during the use of the DIYAPS.

Conclusion:

DIYAPS is safe and effective in Chinese children with T1D, particularly in improving TIR.

Keywords

children closed-loop system do-it-yourself artificial pancreas systems type 1 diabetes

Introduction

Diabetes mellitus is a complex metabolic disorder caused by chronic hyperglycemia resulting from defects in insulin secretion and/or insulin action, which leads to disorders of carbohydrate, fat, and protein metabolism. Type 1 diabetes (T1D) is caused mainly by insufficient insulin secretion.¹ In a study conducted in Turkey, the mean age at diagnosis of T1D decreased from 9.5 to 7.1 years over a 50-year period.² The T1D incidence (per 100,000 persons) significantly increased from 2.72 in 2007 to 3.6 in 2017, the T1D onset peak was in the 10–14-year-old age group, and the prevalence of diabetic ketoacidosis (DKA) at diagnosis was greatest in the 0–4-year-old age group in China.³ These data suggest that T1D patients are not only numerous but also tend to be younger.

Two major goals of T1D blood glucose management are controlling hyperglycemia and preventing hypoglycemia. The commonly used continuous glucose monitoring (CGM) parameters in clinical practice include time in range (TIR, 3.9–10.0 mmol/L), time above range (TAR, >13.9 mmol/L, level 2), TAR (10.1–13.9 mmol/L, level 1), time below range (TBR, <3.0 mmol/L, level 2), TBR (3.0–3.8 mmol/L, level 1), glycemic variability (%CV) target ⩽36%, and mean glucose level.⁴ Although HbA1c can reflect the average glucose concentration over the last 2–3 months, it also has limitations, such as a lack of glucose information about acute complications and a failure to identify transient blood glucose changes. In recent years, the use of real-time CGM has sharply increased, especially in young children.⁵ Charleer et al.⁶ reported that hypoglycemia continued to improve after using CGM. Artificial pancreas systems (APSs), also known as closed-loop systems, consist of a CGM device, a control algorithm, and an insulin pump, all of which are wirelessly interconnected. Based on commercial availability, it is divided into commercial APS and do-it-yourself artificial pancreas system (DIYAPS). Commercial APSs are medical devices approved and certified by relevant regulatory agencies, whereas DIYAPS is a noncommercial alternative system spontaneously developed by the diabetes community in the absence of timely approval from regulatory agencies.⁷ Advanced algorithms and closed-loop control strategies in the DIYAPS system can monitor and adjust insulin infusion in real time, thereby managing blood glucose levels and reducing blood glucose fluctuations.

In China, commercial APSs have not yet been approved by the relevant government authorities; therefore, commercial APSs are not available domestically, and only DIYAPSs are in use. Because DIYAPSs are more advanced diabetes management devices, the primary channels through which children with T1D and their parents learn about them are twofold: (1) via doctors who assess the child’s condition and needs and then introduce and recommend DIYAPS to parents; or (2) online and through attending educational lectures. Notably, the application of DIYAPS in China is still in a stage of ongoing exploration and development.

DIYAPS can improve HbA1c levels in adults with T1D (7.3% ± 1.1% vs 6.5% ± 0.7%; p < 0.001).⁸ Additionally, Braune et al.⁹ found that blood glucose control significantly improves in children (median age: 10 years) using DIYAPS, with HbA1c levels decreasing (from 6.91% (SD 0.88) to 6.27% (SD 0.67); p < 0.001) and TIR increasing (from 64.2% (SD 15.94) to 80.68% (SD 9.26); p < 0.001). The youngest child known to have used APS is a 7-month-old child who used a commercial APS to manage blood glucose; the TIR reached 76%, the TBR (<3.9 mmol/L) was 1%, and no severe hyperglycemia occurred during the use of the APS,¹⁰ which is a reassuring report. Adults’ research by Weng Jianping in China revealed that the use of a DIYAPS significantly decreased the HbA1c of T1D patients (6.79% vs 7.63%) and the fear of hypoglycemia, and it significantly improved glucose management and quality of life.¹¹ “Lancet Diabetes Endocrinology” published the first international consensus on DIYAPSs, which supports the use of DIYAPS in clinical settings.¹²

Therefore, the aim of this study was to evaluate the effectiveness of using DIYAPS for blood glucose management in Chinese children with T1D. The main evaluation indicators included HbA1c and TIR. In China, studies on DIYAPSs have only been conducted in adults, and the application of DIYAPSs in the pediatric population has not been reported.

Methods

Study population

This study was retrospective and conducted in an out-of-hospital environment. The inclusion criteria were as follows: (1) had T1D; (2) were aged 3–18 years; (3) had 3 months of insulin pump therapy data recorded prior to using the DIYAPS; (4) had a record of continuous use of the DIYAPS for 3 months; and (5) had laboratory tests of glycated hemoglobin and fasting blood glucose recorded before and after the DIYAPS was used. The exclusion criterion was any disease that interferes with or affects blood glucose metabolism (see Supplemental Materials).

All the data were obtained from the patient’s blood glucose record database. Insulin pump therapy was defined as the baseline period (pre-DIYAPS), and 3 months of DIYAPS use was defined as the study period (post-DIYAPS). Additionally, we conducted exploratory subgroup analyses based on baseline glycated hemoglobin and age to further evaluate the effectiveness of DIYAPS. The technicians provide each patient with consumables and after-sales services, including 6–8 h of setup and technical support, as well as after-hours assistance via phone or online contact.

Devices

The participants used one of two available DIYAPS systems, either AndroidAPS (AAPS) or LOOP, which were self-selected by the patient or parent.

AAPS is an open-source application that runs on an Android smartphone. Smartphones receive data from CGM devices and communicate with insulin pumps through Bluetooth. The basic settings include basal rates, insulin sensitivity factor, carbohydrate ratio, and duration of insulin action. AAPS can provide remote monitoring and relevant data using the NSClient app on the patient’s Android phone. LOOP runs on the Apple operating system. The Apple iPhone can receive CGM data and communicate with the insulin pump via Bluetooth. LOOP predicts future blood glucose levels every 5 min and provides recommendations for temporary basal rates and automatic boluses. This application enables wireless communication and interaction between insulin pumps, iPhones, and CGMs through Riley Link.¹³

Outcomes

The primary outcomes were the percentage of time that the glucose level was within the target range of 3.9–10.0 mmol/L within 3 months before and after the DIYAPS was used, as measured by the CGM devices, and the change in HbA1c during the period. The secondary outcomes included changes in other ranges, including the percentage of time for which the glucose level was below 3.0 and 3.9 mmol/L, and the percentage of time for which the glucose level was above 10.0 and 13.9 mmol/L. Safety outcomes included severe hypoglycemia and DKA.

Statistical analysis

Continuous variables are represented as the mean ± SD if normally distributed, or median (Q1–Q3) if not normally distributed. Variables between baseline and the study period were compared using the paired t test for continuous variables if the variable followed a normal distribution or the Wilcoxon signed-rank test for continuous variables if not normally distributed. Statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA), and statistical significance was defined as two-tailed p < 0.05.

Results

From September 2022 to July 24, 2024, a total of 41 people participated in this study (see the flow chart in the Supplemental Materials). Supplemental Table 1 describes the baseline characteristics of the 41 DIYAPS enrollees. Among the 41 patients, 21 were males and 20 were females; the mean age was 9.4 ± 2.9 years; the body mass index was 19.3 ± 4.8 kg/m²; HbA1c was 6.6% (6.1–7.6); fasting blood glucose was 8.2 mmol/L (7.2–9.4); the duration of insulin pump therapy was 1.1 years (0.8–1.7); the duration of T1D was 1.5 years (1.1–2.3); the total daily insulin dose was 0.8 U/kg.d (0.7–1.0); and the insulin type used was insulin aspart. The insulin pump therapy used before DIYAPS did not include any automated algorithms.

The baseline (pre-DIYAPS) and post-DIYAPS glycaemic data are shown in Supplemental Table 2. Overall, compared with that at baseline, the TIR increased from 72.4% (57.9–82.4) to 80.8% (73.6–87.5) after 3 months of DIYAPS use (p < 0.01), the HbA1c decreased from 6.6% (6.1–7.6) to 6.3% (5.9–6.9; p < 0.05), fasting blood glucose decreased from 8.2 mmol/L (7.2–9.4) to 6.7 mmol/L (6.3–7.6; p < 0.01), and the sensor mean glucose level decreased from 7.3 ± 1.3 to 6.8 ± 1.1 mmol/L (p < 0.01). TAR (>10 mmol/L) decreased from 16.0% (8.2–21.2) to 8.8% (5.2–14.4; p < 0.01). TAR (>13.9 mmol/L) also decreased from 3.0% (1.5–7.5) to 2.0% (1.1–6.2; p < 0.05). The TBR (<3.9 mmol/L) decreased from 5.0% (2.1–8.3) to 4.1% (2.4–7.4; p = 0.091), and the TBR (<3.0 mmol/L) decreased from 1.0% (0.6–3.3) to 0.8% (0.2–2.2; p = 0.064), however, the changes in these two indicators from pre-DIYAPS to post-DIYAPS were not statistically significant (Supplemental Table 2).

Forty-one participants were divided into a well-controlled group (HbA1c <7%) and a suboptimally controlled group (HbA1c ⩾7%) on the basis of baseline HbA1c levels. In the well-controlled group, after DIYAPS use, the TIR increased from 77.9% (69.5–85.3) to 81.6% (77.4–88.8; p < 0.01), the fasting blood glucose decreased from 7.5 mmol/L (7.0–8.9) to 6.6 mmol/L (6.3–7.6; p < 0.01), and the TAR (>10 mmol/L) decreased from 12.2% ± 7.1% to 8.2% ± 5.1% (p < 0.01). In the suboptimally controlled group, after DIYAPS use, the TIR increased from 61.8% ± 13.9% to 74.8% ± 11.9% (p < 0.01), the fasting blood glucose decreased from 8.8 mmol/L (7.4–10.3) to 7.1 mmol/L (6.3–8.0; p < 0.01), and the TAR (>10 mmol/L) decreased from 21.0% ± 9.2% to 13.3% ± 7.8% (p < 0.01). Notably, the suboptimally controlled group demonstrated a greater improvement in the TIR, which reached 13% (Supplemental Tables 3 and 4).

The participants were categorized by age into school-aged (aged >7 years) and preschool-aged (aged ⩽7 years) groups. In the preschool group, compared with baseline, the TIR increased from 69.2% (51.5–83.0) to 82.3% (71.2–85.1; p < 0.05), the fasting blood glucose decreased from 8.7 ± 1.9 to 6.9 ± 0.9 mmol/L (p < 0.05), the TAR (>10 mmol/L) decreased from 15.7% ± 7.7% to 9.6% ± 6.7% (p < 0.05), and the mean glucose value decreased from 7.6 ± 1.5 to 7.0 ± 1.2 mmol/L (p < 0.05). In the school-aged group, the TIR increased from 73.2% (58.9–82.6) to 80.1% (74.1–88.0) after DIYAPS use (p < 0.01), the fasting blood glucose decreased from 7.6 mmol/L (7.1–8.9) to 6.8 mmol/L (6.3–7.7; p < 0.01), the TAR (>10 mmol/L) decreased from 15.1% (7.2–21.7) to 8.8% (5.4–13.2; p < 0.01), and mean glucose value decreased from 7.1 ± 1.2 to 6.8 ± 1.1 mmol/L (p < 0.05). Notably, the improvement in the TIR score in the preschool group was greater than that in the school-aged group, increasing by 13.1% (Supplemental Tables 5 and 6).

Four participants experienced minor issues with their diabetes devices. Among these, two participants encountered problems during the baseline period, namely, insulin pump battery depletion and insulin pump blockage; the other two participants experienced issues during the study period, which were caused by the body pressing on the CGM and the insulin pump controller running out of power. The duration of the malfunctions ranged from a minimum of 5 min to a maximum of 147 min. One participant had significant discrepancies between CGM glucose readings and fingertip blood glucose measurements, and none of the participants experienced any serious adverse events (Supplemental Table 7).

Safety outcomes

No participants experienced severe hypoglycemia, DKA, or other serious adverse events during the period of DIYAPS use.

Discussion

Our findings showed that the use of DIYAPS effectively assisted in glycaemic management in children with T1D, compared with treatment with insulin pumps alone. In this study, we not only focused on CGM blood glucose data but also utilized laboratory-measured HbA1c and fasting blood glucose levels to evaluate children’s blood glucose control. It is worth noting that this study was conducted in an environment where DIYAPS received technical assistance, providing a reference (such as offering online support) for the safe, effective, and widespread implementation of DIYAPS. A 2024 research report noted that T1D is an increasingly serious global health problem among adolescents and young people. Although advancements have been made in T1D treatment and management, the global burden remains substantial, with both the incidence rate and severity continuing to increase.¹⁴ Poor glucose control can cause both short-term and long-term complications in patients, affecting their quality of life. Children, a special group with developing cognitive abilities, communication challenges, and greater dependence on parents, require additional support, especially children with T1D, who require more attention and care from their parents than children without diabetes; consequently, applying the DIYAPS in this population presents unique challenges.

Both HbA1c and TIR are widely recognized as key indicators of blood glucose control and are associated with the risk of microvascular and macrovascular complications.^15–17 Therefore, improving blood glucose control is essential for delaying the onset and progression of diabetes-related complications. In addition to existing literature demonstrating the effectiveness of APS.^18,19 Our study further supports the role of DIYAPS in improving glycemic outcomes. Specifically, HbA1c levels decreased from 6.6% (6.1–7.6) to 6.3% (5.9–6.9; p < 0.05), representing a mean reduction of 0.3% following the use of DIYAPS. This improvement in glycemic control may contribute to delaying the onset of diabetes-related complications in children with T1D. Research shows that maximizing HbA1c control and reducing long-term fluctuations may provide additional protection against the development of microvascular complications.²⁰ And the TIR was found to be increased by 8.4 percentage points (this value is the value post-DIYAPS minus the value pre-DIYAPS). Subgroup analysis revealed that the greatest improvements occurred in participants from the suboptimally controlled group and the preschool group, with increases of 13% and 13.1%, respectively. People with lower baseline TIR values have greater improvement in TIR after the use of APSs, and patients with lower baseline HbA1c levels have greater TIR when APSs are used,²¹ and subgroup analysis is consistent with previous studies. For preschool group children, the significant improvement in TIR may be related to the extended time they spend with their parents. During this period, parents can assist in blood glucose management. In contrast, school-aged children spend longer periods at school and are separated from their parents, which makes it more difficult for parents to provide effective support for blood glucose control. Lum et al.²² reported that a DIYAPS can increase the TIR in children with T1D, and the average TIR after 4 weeks of DIYAPS use reached 82.4% ± 7.8%.²³ Our study is consistent with previous studies.

The safety of DIYAPS is crucial for children with T1D. Fortunately, previous qualitative and quantitative studies^24,25 have demonstrated its safety, with no reported cases of DKA or severe hypoglycemia. Similarly, DKA and severe hypoglycemia did not occur in this study, suggesting that DIYAPS may be safe for children with T1D. However, further large-scale studies, such as randomized controlled trials, are necessary to confirm its safety. In addition, potential hardware malfunctions—such as tubing failures—should be carefully taken into account when implementing DIYAPS.

One of the key limitations of this study is the relatively small sample size, with only 41 participants included in the final analysis. This limited sample size was primarily due to the exclusion of a significant number of users based on strict inclusion criteria, such as insufficient usage data, lack of physical examination results, or not meeting the required diabetes history and pump usage duration. Although these criteria were necessary to ensure data reliability and relevance, they also reduced the generalizability of the findings. In addition, the small sample size limits the statistical power of the analyses, increasing the risk of type II errors and potentially affecting the robustness of the conclusions. Furthermore, as a retrospective study, we were unable to strictly control for all potential confounding factors, such as diet and family support. Therefore, future research should consider adopting prospective designs with larger sample sizes to improve the reliability and universality of the research results and extend the study period to further explore the effectiveness of DIYAPSs.

Children require parental care. If children are treated with APS and medical guidance, such as dietary and exercise counseling or health education, their glucose may be better controlled. However, during this process, physicians need to invest a significant amount of energy and time, which poses a challenge for them. Continuous use of diabetes devices can help prevent the occurrence and progression of macrovascular complications (such as cardiovascular diseases) by improving blood glucose trends.²⁶ More DIYAPS are expected to assist in research on blood glucose management in children with T1D. With the advancement of technology, innovations in APSs have improved the quality of life of children with T1D.

Conclusion

In summary, this study demonstrated that the application of DIYAPSs for 3 months in Chinese T1D children is safe and effective in real-world environments, particularly in improving the TIR. Large-scale studies on the application of DIYAPSs in children are needed to provide supporting evidence.

Supplemental Material

sj-docx-1-tae-10.1177_20420188251347028 – Supplemental material for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study

Supplemental material, sj-docx-1-tae-10.1177_20420188251347028 for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study by Lihong Yang, Fei Xie, Linqi Han, Fengyan You, Zhiqiang Wei, Caihong Liu, Chao Xu and Yan Sun in Therapeutic Advances in Endocrinology and Metabolism

Supplemental Material

sj-docx-2-tae-10.1177_20420188251347028 – Supplemental material for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study

Supplemental material, sj-docx-2-tae-10.1177_20420188251347028 for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study by Lihong Yang, Fei Xie, Linqi Han, Fengyan You, Zhiqiang Wei, Caihong Liu, Chao Xu and Yan Sun in Therapeutic Advances in Endocrinology and Metabolism

Supplemental Material

sj-docx-3-tae-10.1177_20420188251347028 – Supplemental material for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study

Supplemental material, sj-docx-3-tae-10.1177_20420188251347028 for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study by Lihong Yang, Fei Xie, Linqi Han, Fengyan You, Zhiqiang Wei, Caihong Liu, Chao Xu and Yan Sun in Therapeutic Advances in Endocrinology and Metabolism

Supplemental Material

sj-docx-4-tae-10.1177_20420188251347028 – Supplemental material for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study

Supplemental material, sj-docx-4-tae-10.1177_20420188251347028 for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study by Lihong Yang, Fei Xie, Linqi Han, Fengyan You, Zhiqiang Wei, Caihong Liu, Chao Xu and Yan Sun in Therapeutic Advances in Endocrinology and Metabolism

Supplemental Material

sj-docx-5-tae-10.1177_20420188251347028 – Supplemental material for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study

Supplemental material, sj-docx-5-tae-10.1177_20420188251347028 for Effective blood glucose control in Chinese children with type 1 diabetes via a do-it-yourself artificial pancreas system: a single-center study by Lihong Yang, Fei Xie, Linqi Han, Fengyan You, Zhiqiang Wei, Caihong Liu, Chao Xu and Yan Sun in Therapeutic Advances in Endocrinology and Metabolism

Footnotes

Appendix

Acknowledgements

We thank Shandong Xinyue Health Technology Co., Ltd for providing technical and financial support. We thank to Huiguang Zhang, Fangzhou Wei, and Wenhua Zhai for their contributions to device maintenance and related tasks and all the participants for providing their data.

Declarations

ORCID iD

Yan Sun

Supplemental material

Supplemental material for this article is available online.

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Supplementary Material

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