Kosta K, Grammatikopoulou MG, Toulia I, Smyrnaki P, Paschalidou EG, Vamvakis A, Bogiatzoglou A, Tzimos C, Tsiroukidou K. Patient satisfaction and performance of the A8+ TouchCare Nano in children and adolescents with type 1 diabetes mellitus. World J Clin Pediatr 2026; 15(3): 118236 [DOI: 10.5409/wjcp.118236]
Corresponding Author of This Article
Maria G Grammatikopoulou, PhD, Assistant Professor, Immunonutrition and Clinical Nutrition Unit, Department of Rheumatology and Clinical Immunology, University General Hospital of Larissa, Faculty of Medicine, School of Health Sciences, University of Thessaly, Biopolis Campus, Argonafton and Filellinon Street, Larissa GR-41223, Greece. mgrammat@uth.gr
Research Domain of This Article
Endocrinology & Metabolism
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Kosta K, Grammatikopoulou MG, Toulia I, Smyrnaki P, Paschalidou EG, Vamvakis A, Bogiatzoglou A, Tzimos C, Tsiroukidou K. Patient satisfaction and performance of the A8+ TouchCare Nano in children and adolescents with type 1 diabetes mellitus. World J Clin Pediatr 2026; 15(3): 118236 [DOI: 10.5409/wjcp.118236]
Konstantina Kosta, Ilektra Toulia, Eleni G Paschalidou, Antonios Bogiatzoglou, Kyriaki Tsiroukidou, Pediatric Endocrinology Unit, 3rd Department of Pediatrics, Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki, Thessaloniki GR-54124, Kentrikí Makedonía, Greece
Maria G Grammatikopoulou, Immunonutrition and Clinical Nutrition Unit, Department of Rheumatology and Clinical Immunology, University General Hospital of Larissa, Faculty of Medicine, School of Health Sciences, University of Thessaly, Biopolis Campus, Larissa GR-41223, Greece
Co-first authors: Konstantina Kosta and Maria G Grammatikopoulou.
Author contributions: Kosta K and Grammatikopoulou MG contributed equally to this article, they are the co-first authors of this manuscript; Kosta K, Toulia I, and Smyrnaki P contributed to data collection; Grammatikopoulou MG contributed to the methodology, writing; Grammatikopoulou MG, Toulia I, and Smyrnaki P contributed to reviewing and editing the manuscript; Paschalidou EG, Vamvakis A, and Bogiatzoglou A collected the data and created the databases used in the analyses; Tzimos C contributed to the statistical analyses; Tsiroukidou K contributed to the conceptualization, methodology, reviewing, editing and supervising the work; and all authors contributed to the interpretation of the study and approved the final version to be published.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Hippokration General Hospital, approval No. 313/24-04-2025.
Informed consent statement: Parents and guardians of all participants provided consent to participation in the study’s protocol.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: All data are available upon request to the senior author.
Corresponding author: Maria G Grammatikopoulou, PhD, Assistant Professor, Immunonutrition and Clinical Nutrition Unit, Department of Rheumatology and Clinical Immunology, University General Hospital of Larissa, Faculty of Medicine, School of Health Sciences, University of Thessaly, Biopolis Campus, Argonafton and Filellinon Street, Larissa GR-41223, Greece. mgrammat@uth.gr
Received: December 28, 2025 Revised: February 22, 2026 Accepted: April 23, 2026 Published online: September 9, 2026 Processing time: 215 Days and 1.2 Hours
Abstract
BACKGROUND
The role of automated insulin delivery systems in type 1 diabetes mellitus (T1DM) is constantly expanding, merging continuous glucose monitoring readings with a control algorithm and a continuous subcutaneous insulin infusion device, i.e. insulin pump.
AIM
To evaluate the effectiveness of a new, open and closed-loop insulin delivery system in children and adolescents with T1DM.
METHODS
Children and adolescents with T1DM (n = 28) were recruited from two pediatric endocrinology clinics situated in Thessaloniki and Crete (Greece), during the year 2025. The Medtrum A8+ TouchCare Nano system was used on all patients and comparison of glycemic control and treatment satisfaction were evaluated before and after the introduction of the new system.
RESULTS
The results showed increased patient satisfaction with the continuous subcutaneous insulin infusion, in particular when the closed-loop system was integrated. Participants were satisfied with most of the system’s features, including the predictive low glucose suspend feature, aiming in preventing hypoglycemic episodes and the Auto Meal Handling feature, adjusting the carbohydrate content of each meal without necessitating carbohydrate counting. Time in range, glycosylated haemoglobin levels glucose management indicator, time above range, very high glucose levels, time in tight range and average blood glucose levels were improved after the introduction of the new system. The results remained similar even when closed/open loop systems were evaluated, or when the sample was divided in pre-pubertal/pubescent participants. No adverse events were recorded.
CONCLUSION
The results indicate the that Medtrum A8+ TouchCare Nano system is safe and effective in maintaining and improving glycemic control in children and adolescents with T1DM. More research on pediatric patients is required to further verify these results.
Core Tip: We showed that the Medtrum A8+ TouchCare Nano system is safe and efficient to use among pediatric and adolescent patients with type 1 diabetes mellitus. Furthermore, high treatment satisfaction was recorded among participants after switching to the Medtrum system. Collectively, the present findings add to the available data on the performance and efficacy of the system, paving the way for a more evidence-based prescription of the TouchCare Nano in youngsters with type 1 diabetes mellitus.
Citation: Kosta K, Grammatikopoulou MG, Toulia I, Smyrnaki P, Paschalidou EG, Vamvakis A, Bogiatzoglou A, Tzimos C, Tsiroukidou K. Patient satisfaction and performance of the A8+ TouchCare Nano in children and adolescents with type 1 diabetes mellitus. World J Clin Pediatr 2026; 15(3): 118236
The role of automated insulin delivery (AID) systems in diabetes mellitus is constantly expanding, merging continuous glucose monitoring (CGM) readings with a control algorithm and a continuous subcutaneous insulin infusion (CSII) device, i.e. insulin pump[1]. Additionally CGM measures glucose levels each 1-5 minutes, and average glucose levels are being recorded every 5-15 minutes, for a total of 24 hours a day, on a continuous and comprehensive manner[2]. Furthermore, CGM enables improved visualization, allowing individuals with diabetes to better understand their glycemic targets and achieve tailored control[2]. With glycosylated haemoglobin (HbA1c) expressing the average glucose levels in the 2-3 months prior to each measurement and a variety of inherent limitations, time in range (TIR) offered by the AID systems, gains residence in diabetes monitoring[3,4], being considered as some researchers as the new “gold standard” in diabetes management[2].
Research indicates that the use of CGM offers a wide range of advantages for the patients, including improved HbA1c and glycemic control outcomes[5], ameliorated quality of life and self-care efficacy[6,7], fewer hypogycemic episodes[8], reduced cardiovascular risk[9], treatment satisfaction and improved well-being[10]. Closed loop hybrid systems in particular are gaining residence among pediatric patients[11] as they are associated with less management burden, improved sleep, less treatment-related anxiety, better and more comprehensive glycemic control and a reduced risk for hypoglycemic episodes[12-14]. In the hybrid closed loop systems, the patient inserts manually the g of carbohydrate content of each meal into the insulin pump, and the system uses CGM data to calculate and deliver the correct mealtime insulin bolus.
Proper validation of CSII devices is important for improved clinical efficacy and safety, patient acceptance and clinical confidence when prescribing the device to specific patient populations. Thus far, the Medtrum A8+ TouchCare Nano has been validated in adults with type 1 diabetes mellitus (T1DM)[15-19] in Turkey, Italy and Argentina, while previous versions of the hybrid closed loop system (A7 and A6 Touchcare Nano) have also been validated in patients residing in China[20] and France[21]. Advantages of the Medtrum A8+ TouchCare Nano include the sticker-style, non-invasive pump, the large capacity of the insulin reservoir tank, a lightweight (weighing no more than 14.6 g), small pump compared to the other available devices, and the easiness to control through a personal digital assistance or smartphone. However, all studies have used adult populations as samples and there is no research yet, evaluating the system’s efficacy and treatment satisfaction in children and adolescents with T1DM.
Recognizing this gap in the literature, the aim of the present study was to assess patient satisfaction and real-world efficacy of the A8+ TouchCare Nano AID system in children and adolescents with T1DM.
MATERIALS AND METHODS
Sample recruitment
Children and adolescents with a T1DM diagnosis were recruited from 2 sites in Greece. The first site was the Pediatric Endocrinology Unit situated at Hippokration General Hospital, in Thessaloniki (Greece), and the second clinic was a private pediatric endocrinology practice situated in Heraclion, Crete (Greece).
Inclusion criteria involved: (1) Children and adolescents aged between 7-19 years old; (2) Willing to participate in the study; (3) With parental/guardian consent; (4) With a diagnosis of T1DM; (5) Able to communicate in the Greek language adequately to understand the questions and reply effortlessly; and (6) Wishing to switch therapy from multiple day injections to CSII, or wishing to change their CSII system to the A8+ TouchCare Nano (Medtrum, Shanghai, China). No exclusion criteria were imposed.
A total of 28 children and adolescents fulfilled the inclusion criteria and were included in the sample. Characteristics of the participants are presented in Table 1. Ethical approval for the study was granted by the Scientific board of the Hippokration General Hospital, approval No. 313/24-04-2025. Parents and guardians of all participants provided consent to participation in the study’s protocol.
A case-control design was applied, comparing glucometrics of the previous diabetes regime of the participants to the glucometrics post-introduction of the A8+ TouchCare Nano. In this manner, all patients acted as their own controls.
Patient satisfaction with the A8+ TouchCare Nano
A previously published questionnaire was used to evaluate patient satisfaction with the A8+ TouchCare Nano CSII[21]. Approval for using, adapting and translating the questionnaire was granted by the authors of the original manuscript[21]. The tool uses 14 questions assessing the A8+ TouchCare Nano system, each with possible answers in a Likert scale, ranging from 0 (do not agree) to 5 (totally agree). Adolescents (above 10 years of age) completed the questionnaire alone, on one-on-one interviews with a pediatric endocrinologist, whereas for younger children, the help and opinion of the parents/guardians was also required.
Anthropometric indices
Body weight and stature of participants were measured to the nearest gram and centimeter, respectively, during early morning hours, with the subjects being barefoot, while wearing the minimum amount of clothes possible. A mechanical scale (Seca 700, Seca, Hamburg, Germany) and a wall-mounted stadiometer (Harpenden, Holtain, Crymych, United Kingdom) were employed.
Pubertal status
Pubertal status of each participant was assessed by two experienced pediatric endocrinologists, according to the Tanner staging system[22,23].
Pump characteristics
The A8+ TouchCare Nano pump dimensions are 4.05 cm × 3.15 cm × 1.15 cm and it is made of a durable part (the Pump Base), functioning with a specific reservoir-patch[24]. The pump is strapped on to the patient’s body through its adhesive base[21]. Insulin delivery is facilitated through a 5 mm stainless steel cannula with a 90° penetration into the dermis[24]. The reservoir patches contain up to 300 units of rapid-acting insulin allowing uninterrupted delivery for several days[24].
Glucometrics
Recorded variables included HbA1c (%), glucose management indicator (GMI, %), TIR (70-180 mg/dL, %), time above range (TAR, > 180 mg/dL, %), time below range (TBR, < 70 mg/dL, %), very high glucose levels (> 250 mg/dL, %), very low glucose levels (< 56 mg/dL, %), time in tight range (TITR, 70-140 mg/dL, %), average blood glucose levels (mg/dL), average total daily insulin dose (U) and the number of hypoglycemic episodes per week (n). HbA1c of participants was assessed using a Siemens DCA Vantage point-of-care analyzer (Siemens Healthcare GmbH, Erlangen, Germany).
Statistical analysis
Considering both the small sample size and deviations from normal distribution, non-parametric statistical methods were applied. Specifically, the Wilcoxon signed-rank test was used to assess pre- and post-measurement differences, and the Mann-Whitney U test was used to evaluate between-group differences. Categorical variables are presented as absolute counts with their respective frequencies (%), whereas continuous variables are expressed as means ± SD.
Sensitivity analyses were performed by closed/open loop system and pubertal status. Figures were created using GraphPad Prism (Dotmatics, Boston, MA, United States), version 10. The SPSS software (version 29) was used for all statistical analyses (IBM Statistics, Armonk, NY, United States) and the level of significance was set at α = 0.05. No missing data or drop-outs were recorded.
RESULTS
Table 2 details the changes in glycemic parameters prior to and after the A8+ TouchCare Nano AID system. Improvements were noted in the GMI, HbA1c, TIR, TAR, very high glucose levels, TITR and average blood glucose levels after the use of the A8+ TouchCare Nano AID system. Figure 1 details TIR, TAR and TBR in the total sample, before and after the use of the system.
Figure 1 Time in range (%), time above range (%) and time below range (%) in the total sample, before and after the A8+ TouchCare Nano system (n = 28).
TAR: Time above range; TBR: Time below range; TIR: Time in range.
Table 2 Changes in glycemic control before and after the A8+ TouchCare Nano automated insulin delivery system in the total sample (n = 28), mean ± SD.
Seven participants were on the open loop system and the remaining 21 were assigned to the hybrid closed loop system. Table 3 details the changes in glycemic parameters prior to and after the A8+ TouchCare Nano AID hybrid closed loop system (n = 21). Improvements were noted on the A8+ TouchCare Nano regarding the GMI, HbA1c, TIR, TAR, very high glucose values, TITR and average glucose levels.
Table 3 Changes in glycemic control before and after the A8+ TouchCare Nano automated insulin delivery hybrid closed loop system in the sample (n = 21), mean ± SD.
Differences in the glycemic control before and after the introduction of the A8+ TouchCare Nano AID open loop system (n = 7) are presented in Table 4. Improvements were recorded on the A8+ TouchCare Nano with regards to the GMI, HbA1c, TIR, TAR, very high glucose values, TITR and average blood glucose levels of participants.
Table 4 Changes in glycemic control before and after the A8+ TouchCare Nano automated insulin delivery open loop system in the sample (n = 7), mean ± SD.
The sample was additionally divided according to pubertal status. Results regarding the glycemic control of pubescent participants before and after the introduction of the A8+ TouchCare Nano AID system (n = 19) are presented in Table 5. Improvements were noted when patients switched to the A8+ TouchCare Nano regarding the GMI, HbA1c, TIR, TAR, TBR, very high glucose values, TITR and average blood glucose levels.
Table 5 Changes in glycemic control before and after the A8+ TouchCare Nano automated insulin delivery system among pubertal participants with T1 type 1 diabetes mellitus diabetes mellitus (n = 19), mean ± SD.
As for prepubertal children, results regarding their glycemic control before and after the introduction of the A8+ TouchCare Nano AID system (n = 9) are detailed in Table 6. Improvements were noted among prepubertal participants once the A8+ TouchCare Nano was introduced with regards to the GMI, TIR, TAR, TITR and average blood glucose levels.
Table 6 Changes in glycemic control before and after the A8+ TouchCare Nano automated insulin delivery system among prepubertal participants with type 1 diabetes mellitus (n = 9), mean ± SD.
Participant satisfaction with the A8+ TouchCare Nano AID, as recorded by the questionnaire, is detailed in Figure 2. The results indicate that satisfaction with glycemic control and treatment management were high, and so was satisfaction with pump use. Overall, features of the pump and the system were easy to navigate and use, with the participants reporting feeling more free in their everyday lives and safer with the system’s capacities. The users also considered bolus programming as being easy. Protection against hypoglycemic episodes with the predictive low glucose suspend feature was highly appreciated. Inserting the needle was not deemed as painful, and great levels of comfort were noted by participants while wearing the new pump. No adverse events were recorded post-introduction of the A8+ TouchCare Nano system.
Figure 2 Patient satisfaction with the A8+ TouchCare Nano automated insulin delivery and its features (n = 28).
Responses range between 0 (do not agree) to 5 (totally agree).
DISCUSSION
The present study was the first to demonstrate the efficacy of the A8+ TouchCare Nano AID among pediatric patients with T1DM. It also revealed high patient satisfaction with the management offered by the system.
The glucometric results of the patients following the introduction of the A8+ TouchCare Nano AID were improved, indicating better glycemic control and diabetes management. TIR was improved following the introduction of the new system, indicating more stability in the circulating glucose levels of participants. Research indicates that TIR consists of a significant predictor of long-term diabetes complications, offering a practical framework for implementing the core CGM metrics and ambulatory glucose profile in clinical practice[25]. It has been estimated that for every 10% increase in TIR (as observed herein), a reduction in the cumulative incidence of complications is expected[26], including neuropathic, renal, ophthalmological, and cardiovascular complications. Furthermore, no adverse events were recorded, indicating that the system is not only efficient, but also safe for use among children and adolescents with T1DM. Most importantly, the most frequent adverse event of hybrid closed-loop insulin therapy systems among youngsters with T1DM consists of severe hypoglycaemia[27], which, in the case of the A8+ TouchCare Nano is timely predicted via the predictive low glucose suspend feature and thus, cases of severe hypoglycemia were not recorded among the children herein.
According to a recent meta-analysis[28], a significant reduction in HbA1c is expected in AID systems compared to multiple daily injection regimens, although no differences in body weight, hypoglycemia, or diabetic ketoacidosis are apparent among pediatric patients. Furthermore, meta-research indicates that closed-loop systems are superior, with randomized controlled trials of hybrid closed-loop systems compared with CSII plus CGM achieving significant improvements with regards to HbA1c, TIR and hyperglycaemic levels[29]. Glycemic improvements of closed loop systems have also been shown to increase life expectancy by 0.458 years, while offering a cost-effectiveness estimate of £179000 for each quality-adjusted life-year[29].
Previous research on children and adolescents with T1DM has revealed increased treatment satisfaction, better health perception and quality of life and lower diabetes burden with the use of AID systems[30-33]. According to Messaoudi et al[34], CSII treatment, when used appropriately, is reliable and effective in maintaining long-term glycemic control and improved quality of life. Overall, patients included herein were satisfied with most of the system’s features, including the predictive low glucose suspend option, which aims in the timely prevention of hypoglycemic episodes. Furthermore, the Auto Meal Handling feature adjusts the carbohydrate content of each meal without necessitating carbohydrate counting by the user, thereby facilitating its use by younger patients who are not yet educated on carbohydrate counting. The system also allows the user to set customizable alerts for high or low glucose levels, alarms for issues regarding the delivery of insulin, or low reservoir levels, enhancing safety and convenience, particularly among pediatric patients. Additionally, the system allows for flexible basal rates and advanced bolus types (dual- or square-wave boluses), providing customization based on each patient’s lifestyle and personal needs. An interesting feature of the system is the fact that it makes automatic insulin adjustments and bolus recommendations based on each patient’s CGM data (auto mode feature), in order to fine-tune the amount of insulin that is delivered when meals with varying carbohydrate content are consumed. Both these features (the low glucose suspend and the Auto Meal Handling) consist of novel, machine-learning models. The low glucose suspend in particular, is constantly fed with physiological, clinical, metabolomic, and behavioral data that can predict hypoglycemic episodes[35] and automate insulin titration[36,37] in the event of such cases. Artificial intelligence-based closed-loop systems have the advantage of analyzing circulating glucose data in real-time, allowing for the automatic adjustment of insulin delivery, which in turn, results in less time outside optimal glucose ranges[38]. This feature is of particular importance when pediatric patients are concerned, providing more safety for the parents/guardians. According to recent research, advanced technologies and artificial intelligence in diabetes help pediatric and adolescent patients achieve improved glycemia by eliminating several barriers affecting postprandial glycemia[39].
Among the other advantages of the system is also the non-invasive, sticker feature of the pump, which is less painful and seems to be associated with less diabetes-related burden compared to the non-patchable pumps. As for the weight of the pump, it is currently the lightest pump available in the market, making it more discreet, easy to wear and carry, without creating additional burden, particularly among children. The Medtrum A8+ system also has a relatively long battery life, reducing the frequent recharging requirements. Last, but not least, the touchscreen interface allows for easier navigation, making the system more user-friendly than pumps with physical buttons, while offering quicker access to bolus delivery, the settings menu, and other features.
Research on adults evaluating treatment satisfaction with previous versions of the TouchCare Nano AID[21] also revealed high patient satisfaction and good performance. Studies have shown that the Medtrum real-time CGM system is numerically and clinically accurate over a large glucose range, across 7 consecutive days of wear[20]. Furthermore, more recent preliminary real-world observational data on the use of the A8+ TouchCare in adults with T1DM revealed good performance and efficacy[19].
During the past decades, insulin pump use has continuously gained popularity, and CSII is now a standard therapy among patients aged < 15 years old[40]. In parallel, CGM use also rose sharply in the recent years, particularly among young children[40]. Insulin pumps for children often prioritize tubeless patch designs, ensuring more comfort, while enabling lower minimum basal rates for greater sensitivity, while supporting remote monitoring features for parents/guardians. On the other hand, adult pumps tend to offer higher insulin reservoir capacities with complex, customizable settings, whereas pediatric devices focus on the ease of use, smaller doses, and reducing severe hypoglycemic episodes. According to the manufacturer’s guidelines, the A8+ TouchCare Nano incorporates all the features desired in an insulin pump for both pediatric and adult use.
Limitations of the present study include its retrospective design and the relatively small number of recruited participants. However, we only opted in including patients who were eager in switching to the A8+ TouchCare Nano AID, without forcing this treatment to other patients. Although this recruitment pattern did not force the A8+ TouchCare Nano AID to any participants who were not eager to switch systems, it also limited the power of the sample size. An additional limitation involves the lack of an open-ended question regarding the overall satisfaction/dissatisfaction with the system’s features. Although the inclusion of this question would have provided more insight on the use of the system, recording patients’ beliefs and possible issues, it also required a qualitative analysis design, which was not apparent in the present study. For this reason, we only opted in using previously applied questionnaires that could be analyzed in a quantitative manner.
Until today, the A8+ TouchCare Nano AID system was mainly prescribed in adult patients with T1DM due to the lack of pediatric studies assessing its effectiveness[41]. The present study aims to shed light in the effectiveness of the system among pediatric patients with T1DM, revealing high satisfaction associated with its use. Although the study herein serves as the initial step in understanding the efficacy of the A8+ TouchCare Nano AID system in children and adolescents, more studies on pediatric patients are required to evaluate the system’s performance in this population. The Medtrum hybrid loop system has received Conformité Européenne marking for use among patients with T1DM aged ≥ 2 years old[42] and is available under the National Institute of Healthcare and Excellence technology appraisal guidance (TA943)[43]. On the other hand, in the United States, the Food and Drug Administration[42] has approved the system for patients with T1DM aged ≥ 18 years old. Both the European Union and the Food and Drug Administration have approved the system with non-adjunctive labeling[42], indicating that the sensor is accurate enough to calculate insulin doses for meals and correct high glucose levels. Furthermore, two additional clinical studies have been initiated in the Czech Republic (NCT07320495) and France (NCT06363916), aiming to evaluate the efficacy and safety of the system under real-world settings, one of which is also recruiting children and adolescents. Nonetheless, more research is required to validate the present findings and add to the available data on the safety, efficacy and performance of the Medtrum system.
CONCLUSION
The present study showed that the Medtrum A8+ TouchCare Nano AID system is efficient for diabetes management in children and adolescents with T1DM. It also revealed high treatment satisfaction associated with its use, as well as safety, as no adverse events were recorded.
ACKNOWLEDGEMENTS
The authors appreciate the cooperation of all participants and their parents/guardians.
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