Evaluating the Experience ofChildrenWith Type 1 Diabetes andTheir Parents Taking Part in anArtificial Pancreas Clinical TrialOver Multiple Days in a DiabetesCamp SettingDOI: 10.2337/dc16-1073

OBJECTIVE

To explore the experiences of children with type 1 diabetes and their parentstaking part in an artificial pancreas (AP) clinical trial during a 7-day summer camp.

RESEARCH DESIGN AND METHODS

A semistructured interview, composed of 14 questions based on the TechnologyAcceptanceModel, was conducted at the end of the clinical trial. Participants alsocompleted the Diabetes Treatment Satisfaction Questionnaire (DTSQ, parent ver-sion) and the AP Acceptance Questionnaire.

RESULTS

Thirty children, aged 5–9 years, and their parents completed the study. A contentanalysis of the interviews showed that parents were focused on understandingthe mechanisms, risks, and benefits of the new device, whereas the children werefocused on the novelty of the new system. The parents’ main concerns aboutadopting the new system seemed related to the quality of glucose control. Themean scores of DTSQ subscales indicated general parents’ satisfaction (44.24 6

5.99, range 32–53) and trustful views of diabetes control provided by the newsystem (7.8 6 2.2, range 3–12). The AP Acceptance Questionnaire revealed thatmost parents considered the AP easy to use (70.5%), intended to use it long term(94.0%), and felt that it was apt to improve glucose control (67.0%).

CONCLUSIONS

Participants manifested a positive attitude toward the AP. Further studies arerequired to explore participants’ perceptions early in the AP development toindividualize the new treatment as much as possible, and to tailor it to respondto their needs and values.

As type 1 diabetes management moves toward the development and integration ofnew technologies, it becomes more critical to consider the psychological factorslikely to play a significant role in the use of these devices (1). Understanding psy-chological implications and managing expectations are particularly important in thecase of artificial pancreas (AP) technology. As noted by Barnard et al. (2), from a

1Department of Psychology, Second University ofNaples, Caserta, Italy2Pediatric Department and Diabetes ResearchInstitute, Scientific Institute, Hospital San Raf-faele, Milan, Italy3Department of the Woman, of the Child and ofthe General and Specialized Surgery, SecondUniversity of Naples, Naples, Italy4Department of Pediatrics, University of Turin,Turin, Italy5Regional Center for Pediatric Diabetes, PediatricDiabetes and Metabolic Disorders Unit, AziendaOspedialiera Universitaria Integrata of Verona,Verona, Italy6Unit of Endocrinology and Diabetes, BambinoGesu, Children’s Hospital, Rome, Italy7Department of Woman’s and Child’s Health,University of Padua, Padua, Italy8Pediatric Diabetology Unit, Policlinico di Tor Ver-gata, University of Rome Tor Vergata, Rome, Italy9Unit of Metabolic Diseases, Department of Inter-nal Medicine, University of Padova, Padova, Italy10Department of Information Engineering, Uni-versity of Padova, Padova, Italy11Dept. of Electrical, Computer and BiomedicalEngineering, University of Pavia, Pavia, Italy12Department of Civil Engineering and Architec-ture, University of Pavia, Pavia, Italy13Center for Diabetes Technology, University ofVirginia, Charlottesville, VA

Corresponding author: Alda Troncone, alda.troncone@unina2.it.

Received 17 May 2016 and accepted 8 Septem-ber 2016.

This article contains Supplementary Data onlineat http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-1073/-/DC1.

© 2016 by the American Diabetes Association.Readers may use this article as long as the workis properly cited, the use is educational and notfor profit, and the work is not altered. More infor-mation is available at http://www.diabetesjournals.org/content/license.

Alda Troncone,1 Riccardo Bonfanti,2

Dario Iafusco,3 Ivana Rabbone,4

Alberto Sabbion,5 Riccardo Schiaffini,6

Alfonso Galderisi,7 Marco Marigliano,5

Novella Rapini,8 Andrea Rigamonti,2

Davide Tinti,4 Valeria Vallone,9

Angela Zanfardino,3 Federico Boscari,9

Simone Del Favero,10 Silvia Galasso,9

Giordano Lanzola,11 Mirko Messori,12

Federico Di Palma,12 Roberto Visentin,10

Roberta Calore,10 Yenny Leal,10

Lalo Magni,12 Eleonora Losiouk,11

Daniel Chernavvsky,13 Silvana Quaglini,11

Claudio Cobelli,10 and

Daniela Bruttomesso9

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Diabetes Care Publish Ahead of Print, published online October 4, 2016

psychosocial perspective, the AP isunique in taking responsibility for glu-cose concentrations, and it is this trans-fer of trust, along with the burden ofmultiple devices, novelty, and the day-to-day user requirement that makes ac-ceptance of AP technology a challenge.For these reasons, the impact of APtechnology requires a specific evalua-tion of related psychological implica-tions: the opportunity to assess humanfactors and effects on the lived experi-ence is the only way to reduce the risk ofproducing technologies that may be fitfor “glycemic” purposes but unfit for“lived experience” (2,3).Within the existing literature exam-

ining the psychosocial aspects of APtechnologies, most studies have beenperformed on adults. In these studies,participants who directly (4,5) and indi-rectly (by a “paper case description”)(6,7) experienced AP systems, describedthe positive impact of the tested APtechnology, positive attitudes, and ahigh likelihood of future acceptance.Similarly, the evaluation of the parentalfeelings of children and young peoplewith type 1 diabetes about diabetesmanagement through overnight closedloop insulin delivery, revealed trustand a positive attitude toward the newtechnology (8). Barnard et al. (9) evalu-ated the experiences of adolescentswith type 1 diabetes (and their parents)who took part in an overnight closed-loop study in a home setting, and foundthat the psychological and physicalbenefits of the closed-loop system out-weighed the practical challenges report-ed. The two existing studies (10,11)assessing the impact of an AP systemon children under real-life conditionsdescribed reductions in worries abouthypoglycemia and regimen burden, ahigh level of satisfaction, and an in-creased perceived ease of use of thenew technology.In light of the acknowledged impor-

tance of the psychosocial side of AP sys-tems and the critical role that humanfactors play in the adoption and efficientuse of this system, the aim of this studywas to evaluate the experiences of chil-dren with type 1 diabetes (and their par-ents) who took part in an AP clinical trialover multiple days in a diabetes campsetting. It was assumed that the adop-tion and maintenance of a new healthcare regimen is highly dependent on the

subjective perceptions of potentialusers, here including children and theirparents. Since there are currently no ex-isting validated and reliable measuresthat specifically assess the psychosocialaspects of AP systems, variables of theTechnology Acceptance Model (TAM)(12,13) and diabetes treatment satisfac-tion were considered in the currentstudy. The TAM, providing a general ex-planation of the intention to use a spe-cific system, has been adopted as atheoretical framework that can explainand identify psychological variablesthought to be key factors for under-standing and identifying the humanfactor side of AP technology (6,12).Treatment satisfaction is regarded asan important factor in the managementof type 1 diabetes and is assumed toplay a crucial role in predicting adher-ence to a new diabetes regimen, sinceits absence is considered to be a barrierthat is likely to interfere with the opti-mal use of and therapeutic benefitsfrom this technology.

The current study included a two-feature method approach: a semistruc-tured interview to evaluate participants’experience and perceptions of AP tech-nology, and psychosocial questionnairesto assess AP treatment satisfaction andacceptance.

RESEARCH DESIGN AND METHODS

ParticipantsThe participants included 33 childrenand 37 parents (some children were ac-companied by both parents) attendinga diabetes camp for an AP clinical trial.They were recruited from five Italianpediatric centers in Verona, Milano, Tor-ino, Napoli, and Roma. Inclusion criteriawere as follows: age 5–9 years; a diag-nosis of type 1 diabetes for at least12 months; use of an insulin pump andsensor for $3 months; HbA1c level,10%; a family proficient in continuoussubcutaneous insulin infusion/sensor-augmented pump; and the willingnessto send at least one parent to thecamp. Exclusion criteria were diabeticketoacidosis or severe hypoglycemiawithin the last month; concomitant dis-ease; and any medication use or condi-tions that could influence metaboliccontrol, compromise safety, or preventstudy completion. This was an open-label, randomized, crossover trial com-paring 3 days with an AP to 3 days of

parent-managed sensor-augmented pumpuse during a 7-day camp. Therewas a 1-daywashout period between the two treat-ments. Diet and physical activities (staticin the morning and moderate-to-high in-tensity in the afternoon) were kept asconstant as possible during the two studyperiods. The camp also hosted five pedi-atric diabetologists, three diabetolog-ists who were responsible for thestudy, and four bioengineers. Giventhe young age of the children, eachfamily was housed together. Duringthe 3 days of AP use, the system wasused continuously, except for the timeneeded for personal hygiene. As a re-sult, the AP remained fully operational97% of the time. When the AP systemwas active, the study team constantlymonitored the participants through atelemedicine system. More detailsabout the methodology and results ofthe trial have been described previously(14).

Semistructured InterviewTo explore participants’ experience andperceptions of AP technology, a semistruc-tured interviewwasdesignedbasedon theTAM (12,13). In particular, by making ref-erence to the questions used by van Bonet al. (6), for which there is no validatedtranslation for the Italian population, a sur-vey with 14 items adapted for both adultsand childrenwas constructed.Anoverviewof the methods used to develop the semi-structured interview and its contents isgiven in Supplementary Appendix 1. After3 days of AP treatment, a psychologist con-ducted the interviews individually, face toface; the interviews were audio recordedand then transcribed literally. When bothparentswere present, only one parentwasinterviewed.

Questionnaire DataAt the end of the AP treatment periods,the participants’ parents were askedto individually complete the DiabetesTreatment Satisfaction Questionnairefor parents (DTSQ-parent) (15) and theAP Acceptance Questionnaire (7).

The DTSQ-parent version (15) is basedon the widely used eight-item DTSQ foradults (16,17) that was developed andexpanded using extended interviewwork with parents of individuals withtype 1 diabetes. The DTSQ-parent is a14-item measure that enables self-reporting by parents of the satisfaction

2 Artificial Pancreas Experience Diabetes Care

about the current treatment of theirchildren. Treatment satisfaction is thecombined score of the 10 items (items1, 5–9, and 11–14) evaluating satisfac-tion, ease, flexibility, school day, medi-cal support, and continued treatment.The remaining questions relate to per-ceived frequencies of hyperglycemiaor hypoglycemia (items 2–4) and theeffects of the current treatment onthe parents’ life (item 10). All items arerated from 0 (very unsatisfied) to 6 (verysatisfied), and the range of the totalscore is 0 to 84, with higher scores in-dicating better satisfaction. The authorwas initially contacted for permissionto use the DTSQ-parent and for a copyof the instrument itself, and then theItalian version was constructed. It shouldbe specified that a trial-specific versionof DTQS-parent was used, with specificamendments suggested and authorizedby the author herself to make the ques-tionnaire appropriate for the aims of thecurrent study. For example, the clarifica-tion wording “past 3 days” has beenadded to replace “current treatment”in some items of the original DTSQ-parent(Supplementary Appendix 2).The AP Acceptance Questionnaire,

based on the TAM, was developed toexamine the future acceptance of anAP (7). It included 15 items measuringintention to use (items 1 and 2), perceivedusefulness (items 3–10), perceived ease ofuse (items 11–13), and trust in AP (items14 and 15). The questionnaire was trans-lated into Italian fromaprevious study (18)using a forward-back translation proce-dure. For the current study, the question-naire, which usually addressed patients,was modified to also fit the parents. An-swers were given on a 7-point Likert scale,where 0 = strongly disagree, 1 = moder-ately disagree, 2 = somewhat disagree, 3 =neutral, 4 = somewhat agree, 5 = moder-ately agree, and 6 = strongly agree. Ahigher total score indicates higher APacceptance (range 0–90). Further infor-mation on items of the AP AcceptanceQuestionnaire can be found in Supple-mentary Appendix 3.

Data AnalysisThe statistical analysis was performedwith Statistical Package for the SocialSciences (SPSS) version 21.0 for Macin-tosh. Frequencies or descriptive statisticswere run for demographic informationand data from questionnaires.

To quantitatively analyze the inter-views, computerized textual analysiswas applied to the textual corpus ob-tained from the verbatim transcript(both parents’ and children’s answers)of the semistructured interviews. Theparticipants’ answers were copied andcorrected for grammatical errors andpasted into a text file. The namesand surnames of the participants weredeleted. This remaining text constitutesthe text corpus. Textual analysis of theparticipants’ answers was conductedusing a content analysis software pack-age called T-Lab 5.1 (19). Two of thefunctions of T-Lab were used in this re-search: co-occurrence analysis (compu-tation of word association and sequenceanalysis of key words); and thematicanalyses of elementary contexts (ECs).To explore participants’ subjective per-ceptions of AP, a computation of wordassociation was first used to analyze therelationship between theword “AP” andeach other word in the corpus, identify-ing which concepts were most fre-quently associated with “AP” in theentire text, both in parents’ and in child-ren’s interviews. An association chart ofthe word “AP” was constructed withT-Lab to give an impression of the con-textual use of that word in terms ofwhich other words the term under con-sideration often co-occurred. The rela-tive closeness of one word to anotherword in the chart was assessed accord-ing to a parameter called the cosinecoefficient. The sequence analysis iden-tified the key words that are closer tothe word “AP,” selecting the wordswith the highest probability of preced-ing and succeeding the word “AP” inboth parents’ and children’s interviews.

Next, a thematic analysis of ECs wasconducted to identify the content of themain corpus through a small number ofsignificant thematic clusters emergingfrom the text. The clusters divided thetext into a number of themes that rep-resent the content of the narrative. Eachcluster was labeled based on the quali-tative interpretation performed by ana-lyzing the ECs grouped in each themeand the words connected to each clus-ter. Thematic clusters were internallyhomogeneous and externally heteroge-neous. Because of the shortage of textprovided by the children’s interviews,this analysis was performed only on par-ents’ answers. For further information,

see Lancia (19–21) and http://www.tlab.it.

RESULTS

Study Sample CharacteristicsOf 33 enrolled children, one discontinuedparticipation because of a febrile illness,one because of the illness of the parentattending the camp, and one because ofpoor acceptance of camp lifestyle. In total,30 children (19 males) and their parents(N = 34) completed the study (mean age7.66 1.2 years, mean bodyweight 26.066.1 kg, mean height 123 6 8 cm, meanBMI 16.9 6 2.1 kg/m2, mean BMI z-score 20.09 6 0.91, mean HbA1c 7.3 60.9% [576 10mmol/mol], mean durationof type 1 diabetes 4.76 1.6 years, meanpumpuse for 3.361.9 years, andmean totaldaily insulin use of 20.3 6 6.2 units/day(0.78 6 0.16 units/kg/day)] (14).

Semistructured InterviewAltogether, 27 parents (22 mothers) and27 children were interviewed. Sevenparents were not interviewed becausethey were not available during the in-terview period (e.g., they were resting).Only three children refused to be inter-viewed because they were unwilling toleave their current activity.

The concepts most frequently associ-ated with the word “AP” in the entiretext, both in parents’ interviews (Fig.1) and in children’s interviews (Fig. 2),were identified. The higher the cosinecoefficient of a word with respect tothe word “AP,” the closer that word ispositioned to the center of the figure.

Table 1 displays a sorted list of prede-cessors and successors of the word “AP”in parents’ and children’s interviews. Thelist is shown in descending order accord-ing to the probability values (Table 1,Prob.). For example, Table 1 shows thatthe probability that the parents’ answersincluded the word “son” after the word“AP” was 0.033.

The output of the thematic analysesof the ECs resulted in a structure of thefollowing four thematic clusters: check,using, glycemic control, and change. Table2 shows the four thematic clusters, listingthe x2 test values of the most importantlexical units in each cluster. A high x2 valuemeans that the corresponding lexical unitwas central to a cluster.

The four clusters contain words under-lying the parents’ main attitude towardthe use of AP concerning the properties

care.diabetesjournals.org Troncone and Asssociates 3

of the device. Especially in the “change”cluster, some positive aspects and advan-tages of the new technology were empha-sized (e.g., “curiosity,” “new,” “intriguing,”and “positive”). The remaining clustersshowed other positive views concerninggeneral type 1 diabetes management,such as medical examination, frequency

of physician office visits, and diabetescheck data (cluster “check”: “for me/ok,”“reducing,” “improving,” and “better”); APmanagement and related issues and fig-ures involved in this process (cluster “us-ing”: “learning,” “engineer,” and “easy”);and all contents related to the blood glu-cosemonitoring, such as nocturnal glucose

control and glucose level variation control(e.g., resulting from food intake) (cluster“glycemic control”: “peace of mind,” “tobe glad,” and “calm”).

Focusing on words referring to keytroublesome aspects of the AP, themain concerns included the psychologi-cal burden related to the constant effort

Figure 1—AP association chart and related cosine coefficient values: parents’ interviews. (A high-quality color representation of this figure isavailable in the online issue.)

Figure 2—AP association chart related cosine coefficient values: children’s interviews. Examples of ECs where associations between “AP” and“monitoring”were found: monitoring the chart, monitoring glycemic level, monitoring if I feel well, (my classmates) saw AP. Examples of ECs whereassociation between “AP” and “asking” was found: they would ask me “what is it for?”; the teacher would ask me “what is it?”; and they ask mewhether it is a telephone. (A high-quality color representation of this figure is available in the online issue.)

4 Artificial Pancreas Experience Diabetes Care

to adequately manage diabetes (cluster“check”: “thinking,” “being alarmed,”and “continuously”); all emotional cor-relates associated with glucose control,such as fear of hypoglycemia (especiallyduring sleep), the desire to maintain au-tonomous and controlled regulation notaffecting children’s autonomy, and thedesire to minimize stress related to therisk of poor glycemic control (cluster“glycemic control”: “night,” “hypoglyce-mia,” “autonomy,” and “intervening”);and the risks and difficulties of getting

used to the new system (cluster “using”:“being alarmed” and “help”; cluster“change”: “disadvantages,” “difficult,”and “tired”).

Based on the overall number of ECs,the largest cluster was “glycemic con-trol” (31.6%), followed by “using”(27.7%), “change” (26.5%), and “check”(14.2%).

Questionnaire DataThe DTSQ-parent was completed by29 parents (11 fathers and 18 mothers).

Five parents did not complete the ques-tionnaire because they were not avail-able during the administration period.The mean scores of the Treatment Sat-isfaction (44.24 6 5.99, range 32–53)and Perceived Diabetes Control (7.8 62.2, range 3–12) subscales indicated ageneral satisfaction and trustful viewsof type 1 diabetes control provided bythe new system among parents. Themean scores of the Perceived Frequencyof Hypoglycemia (2.596 1.7, range 0–5)and Hyperglycemia (2.83 6 1.56, range

Table 1—List of predecessors and successors to the word “AP” in interviews with parents and children

Parents Children

Predecessors Probability Successors Probability Predecessors Probability Successors Probability

Hypoglycemia 0.067 Managing-to 0.05 Monitoring/seeing 0.154 Beautiful 0.154

Using 0.067 Done 0.033 Trying 0.077 Seeing 0.077

Safe 0.033 Seeing 0.033 New 0.077 Telephone 0.077

Management 0.033 Insulin pump 0.033 Easy 0.077 New 0.077

Days 0.033 Intervening 0.033 Bolus 0.077 Insulin pump 0.077

Hyperglycemia 0.017 Son 0.033 Beautiful 0.077 Glycemia 0.077

Child 0.017 Reality 0.033 Easy 0.077

Beautiful 0.017 Putting 0.017

It is necessary 0.017 Discourse 0.017

Relying on 0.017 Relying on 0.017

Device 0.017 Managing 0.017

I trust 0.017 It is necessary 0.017

Working 0.017 Child 0.017

Table 2—Four clusters obtained from the thematic clustering of ECs from the corpus (parents’ interview)

Cluster no. 1 Check Cluster no. 2 Using Cluster no. 3 Glycemic control Cluster no. 4 Change

Word x2 Word x2 Word x2 Word x2

Medical examination 46.358 Using 69.914 Night 39.378 Disadvantages 74.864

Month 42.77 Ours 40.449 Hypoglycemias 26.498 Seeing/monitoring 39.332

Doctor 31.163 Need 34.28 Glycemias 24.705 Technology 28.808

Thinking 25.168 Being alarmed 28.954 Autonomy 21.96 Only 22.798

For me/ok 24.999 Learning 25.092 Hearing/feeling 21.878 Smartphone 20.337

Telemedicine 24.419 Available 23.816 Management 16.942 Curiosity 20.257

Reducing 21.198 Help 20.593 Peace of mind 16.145 Bringing 19.789

Check up 18.673 Teacher 17.985 To be glad 15.176 Thinking 14.457

Data 18.437 Year 16.444 Insulin 13.884 New 13.165

Checking 15.49 Dad 13.209 One hundred 11.523 Difficult 12.915

Being alarmed 14.114 Alone 13.209 Meal 11.523 Wondering 12.644

Continuously 12.6 Engineer 10.563 Right 11.523 Tired 12.644

Times 12.6 Easy 10.276 Intervening 11.407 To get used 12.644

Treatment 11.483 Relying on 9.404 Sleeping 10.205 Work 11.354

Surely 10.811 Adult 9.404 Advantages 9.787 Intriguing 10.111

Putting 10.768 Time 9.404 Constant 9.214 Morning 10.111

Current 8.978 Reality 9.097 Keeping 9.214 Positive 9.226

Improving 8.978 Discourse 9.083 Basal 9.214 Hoping 8.937

Better 8.978 Person 6.926 Stopping 9.214 Enthusiastic 8.937

Managing to 7.759 Elementary 6.926 Calm 9.214 Changing 8.937

care.diabetesjournals.org Troncone and Asssociates 5

0–6) subscales suggested a low level ofperceived risk of poor glycemic control.The mean score of the item concerningthe effects of the treatment on the par-ent’s life indicated moderate perceivedpositive consequences of using the newsystem (4.2 6 1.18, range 2–6).The AP Acceptance Questionnaire

was completed by 34 parents. Most par-ents (94.1%) noted the intention fortheir child to use the AP in the longterm (85.3% strongly, 8.8%moderately).Furthermore, 67.6% felt strongly and23.7% moderately that the AP wouldimprove their child’s glucose control;70.6% believed strongly and 26.5%moderately that it may reduce the fre-quency of hypoglycemia in their child;and 52.9% believed strongly and 26.5%moderately that it may prevent hyper-glycemia. Of the parents, 70.5% consid-ered AP easy to use (52.9% strongly and17.6% moderately) and 82.4% (47.1%strongly and 35.3% moderately) thoughtthat their children could handle it. Parentshad trust in the system, with 64.7% notingthat the AP will administer the rightamount of insulin and 76.5% believingthat the blood glucose level measured bysensor was correct.

CONCLUSIONS

This study investigated the psychologi-cal aspects of AP technology during day-and-night use. Assessing participantsattending diabetes summer camp, wherethey were able to experience aspects ofhow an AP would work in their daily lifesetting, rather than tightly controlled ex-perimental conditions, allowed for directand more realistic analysis of their sub-jective experience. In addition, sincethere are currently no existing validatedand reliable measures that specifi-cally address the needs of AP as a noveltechnology, a computerized text analysiswas performed for the first time on par-ticipants’ interview answers to betterunderstand and identify the psychologi-cal aspects of the new technology. Auto-matic text analysis has already proven tobe a powerful tool for helping chronicdisease researchers understand the ty-pology and nature of the responses,and the needs of those who are directlyaffected by a severe illness (22,23).In line with evidence from studies

evaluating the impact of the AP testedtechnology (4–7,10,11), the currentresults suggest a substantial positive

experience and approach of participantstoward the AP. In particular, the analysisof participant interviews showed thatthe parents are mainly focused on un-derstanding the mechanisms of thenew device, the risks and benefits of us-ing it in daily diabetes care, and the as-sociated need to obtain assurancesregarding the safety of using the AP inmanaging hypoglycemia. This is clearfrom an analysis of the most relevantwords surrounding the word “AP” (“in-sulin,” “hypoglycemia,” and “meal” fol-lowed by “ immediately,” “basal,”“working,” “sensor,” “child,” “night,”“seeing,” “managing to,” and “school”),and by the words identified as its mainpredecessors (“hypoglycemia,” “using,”“safe,” and “management”) and succes-sors (“managing to,” “seeing,” and “in-tervening”). The children’s perspectivewas characterized by curiosity aboutthe new system as revealed by themost relevant words surrounding theword “AP” in children’s answers (“see-ing/monitoring,” “asking,” “telephone,”“beautiful,” “experience,” “glycemia,”“touching,” “parent,” “teacher,” “new,”and “increasing”), and by its predecessors(“seeing/monitoring,” “trying,” “new,”“easy,” and “beautiful”) and successors(“beautiful,” “telephone,” “new,” and“easy”).

Evaluation of the most frequenttopics in parents’ interviews confirmsthe crucial role that the efficacy of gly-cemic control provided by the new sys-tem played in the parents’ perceptions.The analysis of the lexical units con-nected to the cluster “glycemic control”shows, in fact, that, along with the hopeof better quality of life (“autonomy,” “tobe glad,” “sleeping,” “advantage,” and“calm”), there were some concerns inadopting the new system, already de-scribed in the existing literature (4,6,9),related to the quality of glucose controlthat the new system would provide, es-pecially during nocturnal sleep (“night,”“hypoglycemia,” “peace of mind,” “in-tervening,” and “constant”). Thesedoubts and uncertainties were mostlikely caused by several factors, such asthe fear of changing the usual (and well-known) diabetes regimen, the lack of ex-perience with the new technology, andthe challenges in using a new therapywith related loss or passage of treatmentresponsibility from the parent to a tech-nological device. The weights of the

“using” and “change” clusters providefurther information regarding the rele-vant components shaping parents’ per-ception, such as the commitment andeffort requested of the child and familyin learning and growing accustomed tothe functioning of a new system (“new,”“difficult,” “to get used,” “tired,” and“changing” in the “change” cluster;“help,” “learning,” “easy,” and “time”in the “using” cluster), with related is-sues (i.e., inconvenience of the size ofthe device: “bringing” in the “change”cluster; risks: “to be alarmed,” “relyingon” in the “using” cluster; and “disad-vantages” in the “change” cluster), thepotential need to involve specific figuresto the aim of a proper use of AP (“help,”“engineer,” “relying on,” and “teacher”in the “using” cluster), and curiosity to-ward the new technology (“curiosity,”“new,” “hoping,” and “enthusiastic” inthe “change” cluster). The “check” clus-ter provides further information aboutsome of the possible effects of AP ongeneral disease management, especiallyin terms of changes of commitment andtasks (e.g., how and when to undergomedical examination, frequency of phy-sician office visits: “medical examina-tion,” “month,” “doctor,” “check up,”“times,” and “treatment”) and the re-lated psychological and emotional bur-den resulting from the novelties indiabetes regimen (e.g., the need to thinkand check, the risk of being alarmed:“thinking,” “being alarmed,” “continu-ously” “checking,” and “managing to”).

Data from the questionnaires indi-cated a general parental satisfactionand trustful views of diabetes controlprovided by the new system. Indeed,most parents believed it was easy touse and capable of providing good glu-cose control. Most parents noted theirintention to use the AP and expressed alow level of the perceived frequency ofhypoglycemia and hyperglycemia.

One limitation of this study was thesmall number of participants and theshort duration of the AP period: 3 daysof AP use may not provide a full evalua-tion of the psychological aspects and ac-ceptance of a new device created forlong-term use. Another limitation wasthat two of the used measures, the APAcceptance Questionnaire and the14-item semistructured interview sur-vey, have only preliminary empirical val-idation supporting their use in younger

6 Artificial Pancreas Experience Diabetes Care

patients, parents, and the Italian lan-guage. Furthermore, the subjects in-volved in the current study tended tobe highly motivated, subsequently mak-ing them less representative of the gen-eral type 1 diabetes population toprovide their perspective on an AP sys-tem. These limitations must be ad-dressed in future AP trials.In conclusion, these findings identify

the perceptions and emotions of partic-ipants about using the technology, andtheir ability to trust the new system.These aspects have been shown to becritical to the use and adherence of di-abetes technology (1,2,9), and contrib-ute to a greater understanding of thepsychological impact of AP technology.Although the parents’ concerns do notseem to affect the generally positiveapproach, they must be considered tobetter understand how to increase ad-herence to new diabetes treatmentsand to prevent potential psychologicalbarriers from reducing the likelihood ofAP technology adoption.Further studies are required to exten-

sively explore participants’ perceptionsearly in the AP development to individ-ualize the new treatment as much aspossible and tailor it to respond to theirneeds and values.

Acknowledgments. The authors thank the chil-drenand their families forparticipating in the study.Funding. This study was partially supported byprivate donors and associations of patients withdiabetes. The Italian Research foundation “So-cieta Italiana Diabetologia” provided adminis-trative support. Y.L. is funded by the Agencyfor Management of University and ResearchGrants of the Government of Catalonia, Spain(Beatriu de Pinos grant BP-DGR 2013).Duality of Interest. No potential conflicts ofinterest relevant to this article were reported.Author Contributions. All authors reviewedand provided feedback on drafts of the manu-script. A.T. was chief psychologist of the Naplessite; and contributed to the protocol design, datacollection, data analysis, and drafting of the man-uscript. R.B., I.R., A.S., R.S., A.G., M. Marigliano,N.R., A.R., D.T., V.V., A.Z., F.B., S.G., and D.C.were camp physicians and contributed to datacollection. D.I. was chief pediatrician of theNaples site and campphysician, and contributedto protocol design and data collection. S.D.F. was

senior camp engineer and contributed to dataanalysis. G.L., M. Messori, F.D.P., and L.M. wereengineers responsible for the design and imple-mentation of the control algorithm and teleme-dicine. R.V., R.C., Y.L., and E.L. were campengineers. S.Q. was chief engineer chief of theTelemedicine Unit in Pavia. C.C. was chief of theAP project and camp engineer, and contributed tothe protocol design. D.B. was study coordinatorand camp chief physician; and contributed to theprotocol design, data analysis, and drafting of themanuscript. A.T. andD.I. are the guarantors of thiswork and, as such, had full access to all the data inthestudyandtakeresponsibilityfor theintegrityofthe data and the accuracy of the data analysis.Prior Presentation. Parts of this study werepresented in abstract form at the 9th Interna-tional Conference on Advanced Technologies &Treatments for Diabetes, Milan, Italy, 3–6 Feb-ruary 2016.

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