Motivational Stage at Continuous Glucose Monitoring (CGM) Initiation in Pediatric Type 1 Diabetes Is Associated With Current Glycemic Control but Does Not Predict Future CGM Adherence or Glycemic Control

Open AccessPublished:April 21, 2021DOI:https://doi.org/10.1016/j.jcjd.2021.04.004

      Abstract

      Objectives

      The Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (CGM TIME) Trial is a multicenter, randomized controlled trial in children with type 1 diabetes, comparing simultaneous pump and CGM with CGM initiation 6 months later (Paradigm, Veo, Enlite Sensor, Medtronic Canada). This study addresses the ability of SOCRATES (Stages Of Change Readiness And Treatment Eagerness Scale) to classify children and parents into distinct motivational stages and identify the stages’ association with glycated hemoglobin (A1C) at trial entry and outcomes 6 months after CGM initiation.

      Methods

      Ninety-eight of 99 eligible children 10 to 18 years of age and 137 of 141 eligible parents completed SOCRATES at trial entry and 6 months later. Parent-child agreement for motivational stage was determined by weighted kappa. Linear regression was used to examine association between motivational stage and i) A1C at trial entry and ii) change in A1C and CGM adherence 6 months after CGM initiation.

      Results

      More than 87% of children and 88% of parents were classified into distinct motivational stages, with weak parent-child agreement. At trial entry, motivational stage was associated with A1C, which was 1.02% higher for children in the Action stage than in the Precontemplation stage (p<0.0001). When compared with children of parents in Precontemplation, A1C for children of parents in the Maintenance and Action stages were 0.83% (p=0.02) and 0.36% (p=0.048) higher, respectively. Precontemplation was associated with shorter diabetes duration. Motivational stage at CGM initiation did not predict change in A1C or CGM adherence 6 months later.

      Conclusions

      SOCRATES can categorize children with type 1 diabetes and their parents into motivational stages. Although motivational stage was associated with glycemic control at trial entry, it did not predict future diabetes-related behaviour or A1C.

      Résumé

      Objectifs

      L’essai Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (CGM TIME) est un essai multicentrique, comparatif et à répartition aléatoire auprès d’enfants atteints du diabète de type 1 qui a pour objet de comparer l’utilisation simultanée de la pompe et de la surveillance du glucose en continu (SGC) à l’amorce de la SGC 6 mois plus tard (Paradigm, Veo, capteurs Enlite, Medtronic Canada). La présente étude porte sur la capacité de l’échelle SOCRATES (Stages Of Change Readiness And Treatment Eagerness Scale) à classifier les enfants et les parents dans des stades motivationnels distincts, et de déterminer l’association entre les stades et l’hémoglobine glyquée (A1c) lors de l’inscription à l’essai et les résultats 6 mois après l’amorce de la SGC.

      Méthodes

      Quatre-vingt-dix-huit des 99 enfants admissibles de 10 à 18 ans et 137 des 141 parents admissibles ont rempli l’échelle SOCRATES lors de l’inscription à l’essai et 6 mois après. Nous avons déterminé à l’aide du kappa pondéré la concordance parents/enfant quant au stade motivationnel. Nous avons utilisé la régression linéaire pour examiner l’association entre le stade motivationnel et : i) l’A1c lors de l’inscription à l’essai; ii) les modifications de l’A1c et l’adhésion à la SGC 6 mois après l’amorce de la SGC.

      Résultats

      Nous avons classifié plus de 87 % des enfants et 88 % des parents dans des stades motivationnels distincts, malgré une faible concordance parents/enfant. Lors de l’inscription à l’essai, le stade motivationnel a été associé à l’A1c, qui était 1,02 % plus élevée chez les enfants au stade de l’action que chez les enfants au stade de précontemplation (p < 0,0001). Lorsque nous avons comparé l’A1c des enfants des parents au stade de précontemplation, l’A1C des enfants des parents aux stades du maintien et de l’action était respectivement 0,83 % (p = 0,02) et 0,36 % (p = 0,048) plus élevée. La précontemplation a été associée à une durée plus courte du diabète. Le stade motivationnel à l’amorce de la SGC n’a pas permis de prédire les modifications de l’A1c ou l’adhésion à la SGC 6 mois après.

      Conclusions

      L’échelle SOCRATES peut permettre de classifier les enfants atteints du diabète de type 1 et leurs parents dans des stades motivationnels. Bien que le stade motivationnel ait été associé à la régulation de la glycémie lors de l’inscription à l’essai, il n’a pas permis de prédire le comportement futur associé au diabète ou l’A1c.

      Keywords

      Mots clés

      • Insulin pump therapy and continuous glucose monitoring (CGM) are more likely to be effective when the user is ready to make the necessary behaviour change.
      • When starting pump and/or CGM, glycated hemoglobin was higher for children in the action stage than for those in the precontemplation stage.
      • Although motivational stage was associated with glycemic control at trial entry, it did not predict future diabetes-related behaviour or glycated hemoglobin.

      Introduction

      It is not known when to introduce continuous glucose monitoring (CGM) in children with type 1 diabetes and how to identify those most likely to benefit. The CGM TIME Trial (Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes [www.clinicaltrials.gov, NCT01295788]) is a multicentre, randomized controlled trial (RCT), which explored the impact of timing of CGM initiation in relation to initiation of insulin pump therapy (Enlite Sensor and Paradigm Veo Insulin Pump; Medtronic Canada) on adherence to CGM and glycemic control. The trial demonstrated significantly greater adherence to CGM (adjusted difference of 2.2 hours/day) in participants who started CGM and pump simultaneously compared with those who started CGM 6 months after pump therapy (
      • Lawson M.L.
      • Verbeeten K.C.
      • Courtney J.M.
      • et al.
      Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.
      ). Greater proportion of time spent using CGM was associated with better glycemic control. This study explores the role of motivation for behaviour change and its potential association with current and future glycemic control and CGM adherence.
      The “Stages of Change” model is a concept developed by psychologists James Prochaska and Carlo DiClemente in the early 1980s. The model describes 5 motivational stages through which individuals progress during the process of behaviour change (
      • Prochaska J.O.
      • DiClemente C.
      Stages and processes of self-change of smoking: Toward an integrative model of change.
      ,
      • Miller W.
      • Tonigan J.
      Assessing drinkers’ motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).
      ,
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ): individuals who do not perceive a change in behaviour is required (Precontemplation stage), individuals who begin to weigh the advantages and disadvantages of a change in behaviour (Contemplation stage), those who have decided to make a change in their behaviour in the short term (Determination stage), those in the process of making a change in their behaviour (Action stage) and those who have already made a change and are working to prevent recurrence of their previous behaviour pattern (Maintenance stage) (
      • Miller W.
      • Tonigan J.
      Assessing drinkers’ motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).
      ). This model has remained popular, as change is not conceptualized as a 1-step process or a simple linear progression but, rather, as a cycle that may involve backward movement but usually not the skipping of stages (
      • Littell J.H.
      • Girvin H.
      Stages of change: A critique.
      ). The original SOCRATES (Stages of Change Readiness And Treatment Eagerness Scale) questionnaire was developed by William R. Miller in 1987 for use in substance abuse research (
      • Miller W.
      • Tonigan J.
      Assessing drinkers’ motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).
      ). Trigwell et al (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ) were the first to adapt SOCRATES to assess readiness for change in the context of diabetes management. Few studies have used the full 40-item diabetes version of SOCRATES (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ,
      • Viner R.
      • Christie D.
      • Taylor V.
      • et al.
      Motivational/solution-focused intervention improves HbA1c in adolescents with type 1 diabetes: A pilot study.
      ). Several studies used shorter tools based on the Stages of Change model to assess motivation in children (
      • Kaugars A.S.
      • Kichler J.C.
      • Alemzadeh R.
      Assessing readiness to change the balance of responsibility for managing type 1 diabetes mellitus: Adolescent, mother, and father perspectives.
      ,
      • Kichler J.C.
      • Kaugars A.S.
      • Ellis J.
      • et al.
      Exploring self-management characteristics in youths with type 1 diabetes mellitus: Does membership in a glycemic control category matter?.
      ) with diabetes. The related concept of motivational interviewing, in which the type of intervention is determined by the patient's readiness for change, has also been studied in children with diabetes (
      • Viner R.
      • Christie D.
      • Taylor V.
      • et al.
      Motivational/solution-focused intervention improves HbA1c in adolescents with type 1 diabetes: A pilot study.
      ,
      • Channon S.J.
      • Huws-Thomas M.V.
      • Rollnick S.
      • et al.
      A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes.
      ,
      • Powell P.W.
      • Hilliard M.E.
      • Anderson B.J.
      Motivational interviewing to promote adherence behaviours in pediatric type 1 diabetes.
      ). We chose the Trigwell et al version of SOCRATES to quantify readiness for change in the CGM TIME Trial’s participants as they transitioned from insulin injections to pump therapy and as they began using CGM. Minor alterations in the wording of questions, approved by the authors, allowed the tool to be used by both parents and children (Supplementary Figures 1 and 2).
      We hypothesized that greater CGM adherence and improved glycated hemoglobin (A1C) would be observed in participants classified as being in the Action stage of motivation before initiating CGM. The objectives of this study were to determine the extent to which SOCRATES (Diabetes Version) could classify children with type 1 diabetes and their parents into distinct motivational stages; evaluate the association between motivational stage and glycemic control at study entry; assess child-parent agreement in motivational stage; and determine the association between motivational stage at the time of CGM initiation and change in A1C and CGM adherence 6 months later.

      Methods

      The protocol for the CGM TIME Trial has been published (
      • Lawson M.L.
      • Bradley B.
      • McAssey K.
      • et al.
      The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: Study protocol, recruitment, and baseline characteristics.
      ). The trial included 144 children, 5 to 18 years of age, managed with insulin injections with a minimum 1-year duration of type 1 diabetes. Informed consent signed by all youth and parents, and assent for younger youth, described what was known about the effect of pump with or without CGM on diabetes control in adults with type 1 diabetes, and the uncertainty regarding its effect in pediatrics. Next, our study participants were randomized to start CGM when they switched from injections to an insulin pump (simultaneous group) or 6 months after starting pump therapy (delayed group). SOCRATES was completed by children age ≥10 years of age, as well as parents of all participants in the trial, at the first visit and 6-month study visits. Insulin pump teaching, with or without CGM, depending on randomization, was done during the first study visit. When SOCRATES was completed by more than 1 parent per child at both study visits, an index parent (whose responses were used in the analysis) was chosen a priori according to the priority of mother, then father, then other caregiver. SOCRATES scores from the first study visit were used to evaluate the association between motivational stage and glycemic control at study entry. To determine whether motivational stage at CGM initiation could predict future outcomes, SOCRATES scores from the first study visit were used for the simultaneous group and scores from the 6-month visit for the delayed group, corresponding to the time at which each group of participants started using CGM. The trial was approved by the institutional ethics boards of the participating sites. CONSORT standards for design and reporting of clinical trials were followed.
      SOCRATES consists of 40 statements, with 8 corresponding to each of the 5 motivational stages. The participants scored each statement (e.g. “I really want to make changes in how I look after my diabetes”) on a 5-point Likert scale. Supplementary Figures 1 and 2 demonstrate the selection of SOCRATES questionnaires that were included in the analysis at study entry and at the time of CGM initiation. The point totals for the 8 questions corresponding to each motivational stage were calculated, and each participant was assigned to an overall motivational stage based on the subscale on which they scored most highly. If a participant scored equally highly on ≥2 subscales, then he or she was considered “unclassified.” Participants were excluded from the analysis if <7 items per subscale were answered. When 1 item in a subscale was missing, the value was imputed using the mean value of the other 7 items from that subscale.
      A1C was used as the measure of glycemic control in the CGM TIME Trial because the trial was conducted before time in range became the standard for reporting glycemic control (
      • Battelino T.
      • Danne T.
      • Bergenstal R.M.
      • et al.
      Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range.
      ).
      A1C was analyzed centrally by Gamma Dynacare on a DCCT-validated assay. Change in A1C was calculated as 6-month A1C minus baseline A1C for the simultaneous group and as 12-month A1C minus 6-month A1C for the delayed group. Data on CGM adherence were collected on a weekly basis through CareLink Pro software. The study period for each randomization group was divided into six 4-week (28-day) periods beginning on the pump start day. The outcome of CGM adherence for this study was defined as total CGM hours in the sixth 28-day period after CGM initiation. Because of technical errors, CareLink sometimes did not collect data on all 7 days of a week; however, in each 28-day period, we knew the total number of hours CGM was used and the number of days that data were reported correctly. Therefore, an adjustment was made where the number of CGM usage hours in a projected 28-day period was calculated as follows: total hours/total days × 28 days.

       Statistics

      Demographic data, including age, gender, ethnicity, randomization group and duration of diabetes, were summarized using mean and standard deviation or percentage, as appropriate. A1C was expressed as mean and standard deviation. Comparisons between randomization groups were tested for statistical significance using t test for age, duration of diabetes and A1C. Chi-square test or Fisher exact test were used as appropriate for categorical variables (age group, child gender, parent gender and ethnicity). For the analyses that involved motivational stage, participants who were not assigned to a single stage by SOCRATES (unclassified participants) were excluded from the analysis, as they represent a heterogeneous group and results could not be interpreted in a meaningful way. All analyses, except for parent-child agreement, were performed separately for parents and children. The percentage of individuals who could be classified into a single motivational stage at baseline was calculated for child and parent reports. The binomial proportion confidence intervals for the percentages of children and parents in each motivational stage were estimated using Wilson's method. Parent-child agreement in motivational stage was determined with weighted kappa. Linear regression was used to analyze the association between motivational stage of children and parents and the outcomes of the child's A1C and CGM adherence, adjusted for the child's age group, gender, duration of diabetes and randomization group. Precontemplation was used as the reference group. Age and duration of diabetes were included in the model, as these factors are known to be associated with A1C (
      • Hilliard M.E.
      • Wu Y.P.
      • Rausch J.
      • et al.
      Predictors of deteriorations in diabetes management and control in adolescents with type 1 diabetes.
      ,
      • Pinhas-Hamiel O.
      • Hamiel U.
      • Boyko V.
      • et al.
      Trajectories of HbA1c levels in children and youth with type 1 diabetes.
      ,
      • Clements M.A.
      • Foster N.C.
      • Maahs D.M.
      • et al.
      Hemoglobin A1c (HbA1c) changes over time among adolescents and young adult participants in the T1D Exchange Clinic Registry.
      ). Gender was included by convention. Randomization group was included, as participants were aware of their randomization group before completing SOCRATES, and we hypothesized that randomization group would have an effect on A1C and CGM adherence. The regression estimates and the least-squares adjusted mean for A1C and CGM adherence for each motivational stage were reported, along with their 95% confidence intervals. Unadjusted means for A1C at study entry, change in A1C in the 6 months after CGM initiation and CGM adherence 6 months after CGM initiation were determined, but were very similar to the adjusted means so results are not shown. Statistical analysis was performed at the CHEO Research Institute using SAS version 9.4 (SAS Institute, Cary, North Carolina, United States). Statistical significance was defined as p<0.05.

      Results

      Baseline demographics of participants are shown in Figure 1. Of the 96 children who completed SOCRATES at the first study visit, 48 (50.0%; 95% confidence interval [CI], 40.2% to 59.8%) were classified as Precontemplation. For parents, Precontemplation was the most common motivational stage as well, with 63 of the 137 index parents (46.0%; 95% CI, 37.9% to 54.3%) in this category. Parents were more likely than children to be classified in the Action stage (parents: 39.4%; 95% CI, 31.6% to 47.8%; children: 17.7%; 95% CI, 11.4% to 26.5%), whereas more children were classified as Maintenance (children: 21.9%; 95% CI, 14.8% to 31.1%; parents: 5.8%; 95% CI, 3.0% to 11.1%). Very few participants were in the Contemplation and Determination categories (0% to 1.5%). Nine children (9.4%; 95% CI, 5.0% to 16.9%) and 9 parents (6.6%; 95% CI, 3.5% to 12.0%) were unclassified.
      Figure thumbnail gr1
      Figure 1Flow diagram demonstrating the selection of SOCRATES questionnaires for analysis at the 2 time points in the study (study entry and CGM initiation) and demographics of the study population. A1c, glycated hemoglobin; CGM, continuous glucose monitoring; SD, standard deviation; SOCRATES, Stages of Change Readiness And Treatment Eagerness Scale.
      There was an association between motivational stage of both parents and children and the child's A1C at study entry (Table 1). Children in the Precontemplation stage had the lowest adjusted mean A1C, 1.02% (p<0.0001) lower than those classified as Action. When compared with children with parents in the Precontemplation stage, A1C for children with parents in the Action and Maintenance stages were 0.35% (p=0.048) and 0.83% (p=0.02) higher, respectively. The 1 parent in the Determination stage had a child with a very high A1C; when adjusted, it was 3.28% higher than the mean adjusted A1C for the children of parents classified as Precontemplation (p=0.0006).
      Table 1Multivariable linear regression for association between motivational stage of children and parents as determined by SOCRATES and A1C at study entry
      ParameterNAdjusted estimateSEp ValueChild's adjusted mean A1C at study entry (95% CI)
      Children
       Precontemplation stage48ReferenceReferenceReference7.56% (7.31%–7.80%)
       Contemplation stage10.210.850.817.76% (6.09%–9.43%)
       Determination stage0NANANANA
       Action stage171.020.24<0.00018.57% (8.17%–8.98%)
       Maintenance stage210.350.230.137.90% (7.53%–8.28%)
       Child's age (10–12 years)0.100.180.58NA
       Child's gender (female)0.130.180.47NA
       Duration of diabetes (years)−0.0030.030.92NA
       Randomization group (simultaneous)0.340.180.06NA
      Parents
       Precontemplation stage63ReferenceReferenceReference7.77% (7.54%–8.00%)
       Contemplation stage2−0.530.670.447.24% (5.94%–8.55%)
       Determination stage13.280.930.000611.0% (9.21%–12.9%)
       Action stage540.350.170.0488.12% (7.85%–8.38%)
       Maintenance stage80.830.360.028.60% (7.93%–9.27%)
       Child's age (5–12 years)0.220.180.22NA
       Child's gender (female)0.040.170.80NA
       Duration of diabetes (years)0.020.030.40NA
       Randomization group (simultaneous)0.020.160.89NA
      A1C, glycated hemoglobin; CI, confidence interval; NA, not applicable; SE, standard error; SOCRATES, Stages of Change Readiness And Treatment Eagerness Scale.
      Note: Analysis was adjusted for randomization group and the child's age category (5–12 vs 13–18 years), gender and duration of diabetes. Precontemplation was used as the reference category. The adjusted mean A1C was calculated using the least-squares method. Unclassified participants were not included, as they represent a heterogeneous group.
      At the time of CGM initiation, Precontemplation was the most common motivational stage, with 52 of 95 children (54.7%; 95% CI, 44.2% to 64.4%) and 63 of 133 parents (45.9%; 95% CI, 37.6% to 54.3%) classified as such. Action was the second most common motivational stage for parents, with 44 of 133 parents (33.1%; 95% CI, 25.7% to 41.5%), compared with only 13 of 95 children (13.7%; 95% CI, 8.2% to 22.0%). Maintenance comprised 18.9% of children (95% CI, 12.3% to 28.0%) and 6.8% of parents (95% CI, 3.6% to 12.3%). There were no children in the Contemplation and Determination categories. One parent was classified as Contemplation and 2 as Determination. Twelve children (12.6%; 95% CI, 7.4% to 20.8%) and 14 parents (10.5%; 95% CI, 6.4% to 16.9%) were unclassified.
      No significant association was found between motivational stage at CGM initiation and 6-month outcomes of change in A1C (Table 2) and CGM adherence (Table 3) for children or parents. The only relevant variable in our analysis was for the randomization group; children in the simultaneous group had a 6-month reduction in A1C that was 0.35% greater than the change in A1C in the delayed group (p=0.04). Six months after CGM initiation, children in the simultaneous group used CGM, on average, 3.42 hours/day longer (p=0.03) than children in the delayed group, after adjustment for other variables, including motivational stage.
      Table 2Multivariable linear regression on association between motivational stage of children and parents as determined by SOCRATES completed at time of CGM initiation and change in child's A1C 6 months after CGM initition
      ParameterNAdjusted estimateSEp ValueAdjusted mean difference in child's A1C from CGM initiation to 6 months later (95% CI)
      Children
       Precontemplation stage52ReferenceReferenceReference+0.16% (−0.09% to +0.42%)
       Contemplation stage0NANANANA
       Determination stage0NANANANA
       Action stage13−0.020.300.95+0.14% (−0.39% to +0.68%)
       Maintenance stage18−0.170.260.51−0.009% (−0.45% to +0.43%)
       Child's age (10–12 years)−0.090.210.68NA
       Child's gender (female)+0.110.200.58NA
       Duration of diabetes (years)−0.0050.030.88NA
       Randomization group (simultaneous)−0.330.200.11NA
      Parents
       Precontemplation stage63ReferenceReferenceReference+0.07% (−0.16% to +0.30%)
       Contemplation stage1−0.540.910.56−0.46% (−2.24% to +1.32%)
       Determination stage2−0.650.650.31−0.58% (−1.84% to +0.68%)
       Action stage44−0.0070.180.97+0.07% (−0.21% to +0.35%)
       Maintenance stage9+0.020.320.94+0.10% (−0.49% to +0.68%)
       Child's age (5–12 years)−0.160.180.37NA
       Child's gender (female)+0.210.170.22NA
       Duration of diabetes (years)−0.040.030.23NA
       Randomization group (simultaneous)−0.350.170.04NA
      A1C, glycated hemoglobin; CGM, continuous glucose monitoring; CI, confidence interval; NA, not applicable; SE, standard error; SOCRATES, Stages of Change Readiness And Treatment Eagerness Scale.
      Note: Analysis was adjusted for randomization group and child's age category (5–12 vs 13–18 years), gender and duration of diabetes. Precontemplation was used as the reference category. The adjusted mean difference in A1C was calculated using the least-squares method. Unclassified participants were not included in this analysis, as they represent a heterogeneous group.
      Table 3Multivariable linear regression on association between motivational stage of children and parents as determined by SOCRATES completed at time of CGM initiation and CGM adherence 6 months later
      ParameterNAdjusted estimateSEp ValueAdjusted mean CGM adherence 6 months after CGM initiation (95% CI)
      Children
       Precontemplation stage52ReferenceReferenceReference376.5 (311.3–441.8)
       Contemplation stage0NANANANA
       Determination stage0NANANANA
       Action stage13−64.273.10.38312.4 (180.7–444.0)
       Maintenance stage18−55.266.30.41321.4 (209.9–432.8)
       Child's age (10–12 years)40.053.40.46NA
       Child's gender (female)73.851.20.15NA
       Duration of diabetes (years)10.28.20.22NA
       Randomization group (simultaneous)70.151.40.18NA
      Parents
       Precontemplation stage63ReferenceReferenceReference374.0 (315.1–432.9)
       Contemplation stage1161.2235.90.50535.2 (72.9–997.5)
       Determination stage2−268.7167.90.11105.3 (−221.1 to 431.6)
       Action stage44−38.546.60.41335.5 (261.0–410.1)
       Maintenance stage9−116.482.50.16257.6 (105.0–410.2)
       Child's age (5–12 years)76.446.80.11NA
       Child's gender (female)−12.143.40.78NA
       Duration of diabetes (years)6.27.80.43NA
       Randomization group (simultaneous)95.843.50.03NA
      CGM, continuous glucose monitoring; CI, confidence interval; NA, not applicable; SE, standard error; SOCRATES, Stages of Change Readiness And Treatment Eagerness Scale.
      Note: Analysis was adjusted for randomization group and the child's age category (5–12 vs 13–18 years), gender and duration of diabetes. Precontemplation was used as the reference category. Adjusted mean CGM adherence was calculated using least-squares method. Unclassified participants were not included in this analysis, as they represent a heterogeneous group. CGM adherence is expressed as hours per 28 days.
      Although duration of diabetes was not a significant variable in our multivariate analysis (Tables 1, 2 and 3), duration of diabetes was shorter for children and parents in the Precontemplation stage compared with those in the Maintenance stage. At study entry, children in Precontemplation had a mean duration of diabetes of 2.7 (standard deviation [SD], 2.5) years compared with 5.2 (SD, 3.7) years for those in Maintenance. For parents, the same pattern was noted, with mean duration of diabetes being 2.9 (SD, 2.8) years in the Precontemplation group and 6.9 (SD, 5.4) years in the Maintenance group. A similar trend was noted at the time of CGM initiation. Mean duration of diabetes was 2.8 (SD, 2.7) years for children in Precontemplation compared with 5.3 (SD, 4.0) years for those in Maintenance; for parents, it was 3.2 (SD, 3.0) years for those in Precontemplation and 4.4 (SD, 4.2) years for those in Maintenance.
      After excluding unclassified individuals, there were 79 parent-child pairs who completed SOCRATES during the first study visit. Forty-five of 79 (57.0%) of the children were in the same motivational stage as their index parent. The weighted kappa coefficient when comparing stage of motivation (including only Precontemplation, Action and Maintenance stages, N=77 pairs) was 0.38 (95% CI, 0.21 to 0.55), indicating a weak correlation. Due to a higher proportion of unclassified participants, 72 parent-child pairs were available for comparison at the time of CGM initiation; 33 of 72 (45.8%) were in the same motivational stage as their parent. The weighted kappa coefficient (including Precontemplation, Action and Maintenance stages, N=70 pairs) was 0.15 (95% CI, −0.05 to 0.35).

      Discussion

      The full diabetes version of SOCRATES has not been widely used in published studies (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ,
      • Viner R.
      • Christie D.
      • Taylor V.
      • et al.
      Motivational/solution-focused intervention improves HbA1c in adolescents with type 1 diabetes: A pilot study.
      ) and it has not, to our knowledge, been used in the context of an RCT. Our main findings are that SOCRATES was able to classify the majority of children age 10 years and over and their parents into a single motivational stage; child-parent correlation was weak; motivational stages assigned by SOCRATES were associated with current glycemic control, with individuals in the Precontemplation stage having lower A1Cs than those in the Action and Maintenance stages; and SOCRATES was not able to predict future glycemic control or adherence to CGM.
      Despite differences in patient population, some of our findings were very similar to the results of the 1997 cross-sectional study by Trigwell et al (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ), which included 361 adult participants, 63.7% of whom had type 2 diabetes. In our study and theirs, SOCRATES (Diabetes Version) was able to assign participants into motivational stages over 85% of the time and, in both studies, 40% to 50% of participants were classified as Precontemplation. Our study had a smaller number of participants in the Contemplation and Determination categories. It is the opinion of the authors, as well as some of the parent participants in our trial, that many of the items on the determination subscale (e.g. “I don't look after my [child's] diabetes at all well”) imply poor parenting, and it was difficult for parents to endorse these items.
      For parents and children in our study, and also in the study by Trigwell et al (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ), participants in the Precontemplation stage had lower A1Cs compared with those in the Action and Maintenance stages. This finding was unexpected and it allowed us to reflect on the use of SOCRATES in individuals with type 1 diabetes compared with the population for whom the questionnaire was originally developed—those with addictions (
      • Prochaska J.O.
      • DiClemente C.
      Stages and processes of self-change of smoking: Toward an integrative model of change.
      ,
      • Miller W.
      • Tonigan J.
      Assessing drinkers’ motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).
      ). By definition, an addiction involves a problematic behaviour, and Precontemplation in this context represents the earliest motivational stage, a lack of readiness for change. In contrast, managing diabetes involves many different behaviours, and an individual with good glycemic control may identify with Precontemplation statements, as they may not perceive that a change in behaviour is necessary.
      In our univariate analysis, we found that children and parents classified as Precontemplation had a shorter duration of diabetes than those classified as Maintenance. One explanation for this is the wording of the Maintenance items, which alludes to a history of poor glycemic control followed by better control; this is less likely to be true for participants who were more recently diagnosed. In addition, in our province, insulin pumps are generally offered to children 1 year after their diagnosis of diabetes if they have had good glycemic control during this time and if the child is perceived to be sufficiently mature or parents are primarily responsible for daily diabetes management (i.e. young children). Children in our study who had a longer duration of diabetes, but had never used an insulin pump, may have had a history of poor glycemic control and not been eligible for pump therapy in the past; these individuals may be more likely to agree with the maintenance subscale items. Trigwell et al (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ) hypothesized that participants' knowledge of recent A1C level contributes to their perception of whether change is necessary (
      • Trigwell P.
      • Grant P.J.
      • House A.
      Motivation and glycemic control in diabetes mellitus.
      ), and those with high A1Cs may feel a greater need to take action. When our participants were completing SOCRATES, they had had their A1C measured within the previous 30 days and were aware of the results. Given that SOCRATES is intended to measure readiness for change, we had hypothesized that motivational stage would be more closely associated with future outcomes rather than present glycemic control, but this was not the case. Further research will attempt to identify the barriers that prevented individuals who were motivated to improve their diabetes-related behaviours from doing so successfully.
      It is likely not surprising to those who work with children with diabetes that the correlation between child and parent motivational stage in our study was weak. Previous studies have shown differences in parent and child perspectives in both diabetes management (
      • Kaugars A.S.
      • Kichler J.C.
      • Alemzadeh R.
      Assessing readiness to change the balance of responsibility for managing type 1 diabetes mellitus: Adolescent, mother, and father perspectives.
      ,
      • Powell P.W.
      • Hilliard M.E.
      • Anderson B.J.
      Motivational interviewing to promote adherence behaviours in pediatric type 1 diabetes.
      ) and quality-of-life reporting (
      • Upton P.
      • Lawford J.
      • Eiser C.
      Parent-child agreement across child health-related quality of life instruments: A review of the literature.
      ). In our study, children and parents were equally likely to be classified in the Precontemplation stage, but parents were classified as Action much more often than their children. This may reflect the different reasons that children and parents choose insulin pump therapy—children may emphasize lifestyle reasons, whereas parents may be more focused on the opportunity to improve their child's glycemic control while reducing the frequency of hypoglycemia. Kaugars et al (
      • Kaugars A.S.
      • Kichler J.C.
      • Alemzadeh R.
      Assessing readiness to change the balance of responsibility for managing type 1 diabetes mellitus: Adolescent, mother, and father perspectives.
      ) pointed out that health-care providers often assume that all family members are in the Action stage without individually assessing the motivation of the child and caregiver(s). Our own results emphasize that the parent's perspective is not a proxy for the child's perspective.
      The main limitation of our study is lack of generalizability, as our participants consisted of parents and children with type 1 diabetes who had agreed to participate in a clinical trial in which they would make a major change to their insulin delivery method. Our study was also limited in that 86.5% of the children identified as Caucasian. Although these limitations are significant, we believe that the population of individuals considering starting CGM is a group in which assessment of motivation is important, as CGM teaching involves a significant financial and time commitment, as does ongoing CGM use.
      In conclusion, we found that SOCRATES was effective in categorizing participants into motivational stages, which reflected their current diabetes management; however, it was not helpful in predicting future adherence to CGM and success with sensor-augmented pump therapy. Based on our results, we would not recommend the use of SOCRATES (Diabetes Version) as a predictive tool in children with type 1 diabetes and their parents.

      Acknowledgments

      The authors acknowledge the funding provided by JDRF Canada and the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) through the JDRF Canadian Clinical Trial Network (JDRF CCTN). The role of the JDRF CCTN was to conduct the peer review process before awarding funds, establish statement-of-work agreements and a steering committee to oversee the network studies and ensure quality assurance was maintained through audit of expenditures and monitoring by a third-party contract research organization (Robarts Clinical Trials, Inc). The network has a primary responsibility for oversight of presentations and publications. Funding for all authors was provided through the JDRF CCTN. The JDRF CCTN is a public-private partnership, which includes JDRF International, JDRF-Canada and the Federal Economic Development Agency for Southern Ontario, and is supported by JDRF Canada and the Federal Economic Development Agency for Southern Ontario ( 80-2010-585 ). In addition to CGM TIME Trial funding, K.C.V. received funding from the Canadian Pediatric Endocrine Group Fellowship Program and the Children’s Hospital Academic Medical Organization . This abstract was presented at the 78th Annual Scientific Sessions of the American Diabetes Association on June 25, 2018. This is an investigator-initiated trial. Pumps and CGM supplies were purchased from Medtronic Canada at a discounted price.

      Author Disclosures

      M.L.L. has been a speaker, without receiving honoraria, at educational events sponsored by Medtronic and Animas, with travel reimbursement to attend these events. C.C. has been a speaker and received honoraria for educational events sponsored by Medtronic. K.M. and S.E.K. have been speakers and received honoraria for educational events sponsored by Medtronic, Dexcom and Animas. No other authors have any conflicts of interest to declare.

      Author Contributions

      M.L.L., the principal investigator for the CGM TIME Trial, designed and coordinated the study, reviewed and edited the manuscript and contributed to the discussion. K.C.V. completed the preliminary analyses and wrote and edited the manuscript and the discussion. N.S. and J.C. performed the statistical analysis. M.L.L. is the guarantor of this work and takes responsibility for the accuracy of data collection and analysis.

      Appendix

      Figure thumbnail fx1a
      Supplementary Figure 1The child version of SOCRATES.
      Figure thumbnail fx1b
      Supplementary Figure 1The child version of SOCRATES.
      Figure thumbnail fx2a
      Supplementary Figure 2The parent version of SOCRATES.
      Figure thumbnail fx2b
      Supplementary Figure 2The parent version of SOCRATES.

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