key: cord-0728923-kg4vxxe5
authors: Rabbone, Ivana; Savastio, Silvia; Pigniatiello, Ciro; Carducci, Chiara; Berioli, Maria Giulia; Cherubini, Valentino; Lo Presti, Donatella; Maltoni, Giulio; Mameli, Chiara; Marigliano, Marco; Minuto, Nicola; Mozzillo, Enza; Piccinno, Elvira; Predieri, Barbara; Rigamonti, Andrea; Ripoli, Carlo; Schiaffini, Riccardo; Lombardo, Fortunato; Tinti, Davide; Toni, Sonia; Zanfardino, Angela; Scaramuzza, Andrea Enzo
title: Significant and persistent improvements in time in range and positive emotions in children and adolescents with type 1 diabetes using a closed-loop control system after attending a virtual educational camp
date: 2022-03-21
journal: Acta Diabetol
DOI: 10.1007/s00592-022-01878-z
sha: cddd493a4c64a5e780a5dd1670b674779bbb2352
doc_id: 728923
cord_uid: kg4vxxe5

OBJECTIVE: To evaluate the six-month impact of the advanced automated functions of a closed-loop control (CLC) system (Control-IQ) and a virtual educational camp (vEC) on emotions and time in range (TIR) of children and adolescents with type 1 diabetes. METHODS: Children and their parents participated in a three-day vEC. Clinical, glucose, and emotion data were evaluated before, just after, and six months after the vEC. Emotions were evaluated using adapted Plutchik's and Geneva Emotion Wheels. RESULTS: Forty-three children and adolescents (7–16 years) showed significant improvements in positive emotions immediately and six months after the vEC (67% and 65% vs 38%, p < 0.05, respectively), while mixed emotions were reduced (32% and 15% vs 61%, p < 0.05 and p < 0.001, respectively). The median percentage TIR increased from 64% (IQR 54–72) to 75% (IQR 70–82) with Control-IQ (p < 0.001) six months after the vEC. CONCLUSIONS: Positive emotions (joy, serenity, and satisfaction) significantly improved while mixed emotions were significantly worse six months after the initiation of a CLC system (Control-IQ) and a vEC. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00592-022-01878-z.

Education maximizes the benefits of new diabetes technology. Educational camps, even if run virtually, represent a solid educational and emotional experience for children and adolescents with type 1 diabetes (1). Since negative emotions such as anger, frustration, hopelessness, fear, guilt, and shame are very common in people with diabetes, it is important to evaluate the impact of education on participants' emotions. It is well known that emotions, especially negative emotions, can influence glucose trends in everyday life. Moreover, the literature describes diabetes distress as an affective condition associated with an individual's frustrations, worries, and concerns about living with diabetes. This Extended author information available on the last page of the article state is linked with fewer self-care behaviors, non-optimal glycemic control, and lower quality of life in subjects with type 1 diabetes. Improving diabetes management is therefore an important component of mitigating against these negative feelings and emotions (2, 3) . Defining and comprehensively measuring emotions can be challenging, but camps nevertheless represent an important setting for developing social and emotional learning skills (3) . While no study has evaluated the effects of technology on emotions during or after an educational camp, the psychological impact of technology on children and adolescents with type 1 diabetes and their parents has been evaluated (4-7). Indeed, insulin pumps led to improvements in diabetes-specific emotional distress (8, 9) .

Given that children in particular can find it difficult to describe feelings, emotions can be associated with colors in children and in front of a computer screen (10) . We previously evaluated the effectiveness of a closed-loop control (CLC) system with the Control-IQ algorithm (1) . Building on this study, here we aimed of to evaluate, using colors, the emotional impact of a virtual educational camp (vEC) in children and adolescents with type 1 diabetes using a CLC system with Control-IQ over six months of follow-up. As a secondary outcome, we also evaluated glycemic metrics six months after the vEC.

Nineteen Italian pediatric diabetes centers participated in this prospective, multicenter clinical study, as previously described (1) . The study was approved by the coordinating center Ethical Committee (ASST Cremona) and conducted according to the Declaration of Helsinki. Informed consent was signed by each participants' parents.

With the aim of strengthening educational support for children and their families using a CLC system (Tandem t:slim X2 (San Diego, CA) with the Control-IQ algorithm), a three-day vEC was organized from 6 to 8 November 2020, 13-30 days after users had upgraded from Basal-IQ to Control-IQ (1). Children (6-17 years of age) who had already used the Basal-IQ system for at least three months with the carbohydrate counting system and who were available to test Control-IQ technology and share their data via a data-syncing software (Diasend platform) were enrolled (1) . None of the participants had cognitive deficits, affective disorders (depression, anxiety) or psychiatric diseases or were using psychiatric drugs. None had micro-or macrovascular complications. Participants, their parents, and diabetes teams from each center participated via Zoom (Zoom Video Communications, Inc., San Jose, CA). Using the online platform, the children and their parents participated in a series of activities, either exercising with the guidance of expert personal trainers, or informative (carbohydrate counting, diabetes management during exercise, fine tuning of Control-IQ algorithm), lasting about six hours per day. Various sessions were held by pediatric endocrinologists, expert in diabetes, dieticians, and psychologists. Details of the vEC structure and activities are reported in our previous publication (1). A psychologist (CP) asked each participant to describe their emotions at the end of each day according to the three primary colors. Emotions were subsequently evaluated using Plutchik's Wheel of Emotions and the Geneva Emotion Wheel (12-13) (Supplemental Figs. 1 and 2).

Emotions were evaluated before the vEC, at the end of the camp, and after six months. Participants associated emotion concepts with colors using the provided matching card containing ten standardized emotions/colors (Supplemental Fig. 3 ) according to Plutchik's Wheel of Emotions and the Geneva Emotion Wheel. The feelings of joy, serenity, amazement, and satisfaction were categorized as positive, the others as negative. A mixture of positive and negative feelings was called mixed emotions. Continuous glucose monitoring (CGM)-derived glucometrics were also evaluated.

The primary outcome was changes in emotions at the end of the vEC and after six months; while secondary outcomes included the percentage of time spent in the target range of 70 to 180 mg/dL (TIR) after six months; the percentage of time in which glucose values were < 54 mg/dL, 54-70 mg/ Fig. 1 Frequency of positive and mixed emotions evaluated after upgrading the CLC from the Basal-IQ to Control-IQ algorithm, before vEC, just after the vEC, and six months after the vEC. No children expressed all negative emotions only dL, 180-250 mg/dL, or > 250 mg/dL; the coefficient of variation (%CV); and severe adverse events (severe hypoglycemia and diabetic ketoacidosis episodes).

The statistical analysis is detailed elsewhere (1). The frequency of different emotions at each timepoint was calculated; the comparison of general emotions and differences between positive, negative, and mixed emotions were analyzed with Fisher's exact tests. All statistical analyses were performed using SPSS 22.0 (SPSS Inc., Chicago, IL).

The 43 participants were aged 7 to 16 years (median 12, interquartile range (IQR) 9-13), of whom 53.5% were female. The duration of diabetes ranged from 2 to 13 years (median 6; IQR 4-9). The median BMI z-score was − 0.2 (IQR -0.6-0.2), and 19 (45%) participants were pre-pubertal according to Tanner's classification.

Before camp, the most frequently reported feelings were joy (75.9%), serenity (65.5%), satisfaction (27.6%), fear (27.6%), amazement (24.1%), indifference (17.2%), and anger (17.3%). Just after the vEC, participants reported increases in joy (76.9%, + 1%), serenity (76.9%, + 11.4%), amazement (26.9%, + 2.8%) and reductions in fear (11.5%, − 16.1%), indifference (7.7%, − 9.5%), and anger (3.8%, -9.5%), although these changes were not significant (Table 1) . After six months, amazement (− 24,1%, p < 0.05) and sadness (− 6,9%, p < 0.05) were significantly reduced compared to baseline (Fig. 1) . Merging positive, negative, or mixed emotions, positive emotions increased either just after or six months after the vEC (67% and 65% vs 38%, both p < 0.05), while mixed feelings decreased (32% and 15% vs 61%, p < 0.05 and p < 0.001, respectively) (Fig. 1) . Negative emotions alone were never present either before or after the camp. The median percentage TIR increased from 64% (IQR 54-72) to 75% (IQR 70-82) with Control-IQ (p < 0.001) after six months. Other glucometrics are shown in Table 2 . No severe adverse events (severe hypoglycemia or diabetic ketoacidosis) were reported during the observation period.

In this daily-life study of children and adolescents with type 1 diabetes, participants spent 75% of the time in the target range of 70-180 mg/dl after six months, 11% higher than before using a CLC system and participating in an vEC, confirming the data reported after three months (1) and representing the highest reported percentage TIR in this age group of patients with diabetes.

Similarly, the increase in positive emotions observed at the end of the vEC was confirmed after six months, highlighting the importance of the insulin delivery system used and its efficacy and safety for patient wellbeing.

There is some evidence that educational camps are beneficial to young people with type 1 diabetes. Sharing fun experiences and removing the isolation of living with diabetes contributes to positive emotions over time (14) . It is interesting to note that even though our camp was run virtually (due to COVID-19 constraints), the possibility to share similar experiences-even if only over the internethelped our patients to improve their positive emotions. This improvement has now been confirmed six months after the end of the vEC. Likewise, the use of an innovative technology (CLC system with Control-IQ algorithm) with favorable efficacy and safety (1) helps to positively influence the patient's mood, as recently described (15) .

Evaluating emotions can be challenging, since many factors or circumstances can hypothetically influence them; however, the measures used have focus on specific emotions. Both before the vEC and at follow-up, each child and adolescent was assisted by the same psychologist (CP) to ensure consistency in their answering and approach.

Many studies have focused on mild cognitive deficits and affective disorders such as depression and anxiety in youths and adults with type 1 diabetes (16), but few or none have investigated their emotions. The patients enrolled in the present study did not have any psychiatric disorders, nor were they using psychiatric drugs, which would in any way affect either their emotions or the use of a new technology. Using an effective tool to manage diabetes and glycemic control appears to help children develop more positive emotions like joy, calmness, and satisfaction and decrease negative emotions like anger and fear. The negative feelings reported before the vEC may well have been linked to the anxiety that precedes the start of a new experience, and the positive emotions may be due to the positive effect of sharing experiences and best practices in the vEC. However, the positive effect persisted for six months, suggesting a more fundamental effect of the vEC beyond the experience alone.

Similar positive effects of technology have been reported (6) (7) (8) (9) , helping children to better accept technology (6) and reduce management distress (8) . Diabetes technology is now an integral part of the lives of children with type 1 diabetes. However, children's experiences with these technologies are often overlooked. A recent study found that diabetes technologies prompted children and their parents to use data in daily care and that technologies could be liberating but also result in excess control (17) . Diabetes can be stressful and demanding, but if the outcome (good glycemic control) exceeds expectations, even a demanding device can be accepted (18) (19) (20) . We found that good TIR results were associated with improvements in emotional well-being. Giving the right space to the emotional experiences of children involved probably allowed them to access the fullness of the proposed experience and underscored its significance.

The lack of a control group was a limitation, making it difficult to interpret the contribution of the vEC intervention to the overall effect. However, encouragingly, the TIR was consistently above the recommended target in threequarters of the sample and was maintained over the entire study period, as were improvements in positive emotions. Furthermore, alarms can be intrusive, but our patients all used the previous algorithm (Basal-IQ) before upgrading to Control-IQ and were used to alarms, so we do not believe that alarms significantly impacted our results. The study was strengthened by its multicenter design.

In conclusion, an educational camp organized to improve knowledge and use of an CLC system -even though it was virtual-not only significantly and persistently improved TIR in children and adolescents with type 1 diabetes but also their positive emotions.

Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: a prospective, multicentre, real-life study

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Intermittently scanned and continuous glucose monitor systems: a systematic review on psychological outcomes in pediatric patients

Impact of technology-based interventions for children and young people with type 1 diabetes on key diabetes self-management behaviours and prerequisites: a systematic review

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Acknowledgements There was no funding source for this study. The corresponding author (AES), IR, and SS had full access to the data, and the corresponding author made the final decision to submit for publication. We would like to thank our patients with type 1 diabetes and their families who participated in the study.