# Promoting self-management in adults with type 2 diabetes: development of the impact of glucose monitoring on self-management scale

Michael Vallis, Lori Berard, Emmanuel Cosson, Finn Boerlum Kristensen, Fleur Levrat-Guillen, Nicolas Naiditch, Remi Rabasa-Lhoret, William Polonsky

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## ► To cite this version:

Michael Vallis, Lori Berard, Emmanuel Cosson, Finn Boerlum Kristensen, Fleur Levrat-Guillen, et al. Promoting self-management in adults with type 2 diabetes: development of the impact of glucose monitoring on self-management scale. Canadian Journal of Diabetes, In press, 48 (7), 10.1016/j.jcjd.2024.07.001. hal-04677515

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Submitted on 26 Aug 2024

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Original Research

# Promoting Self-Management in Adults with Type 2 Diabetes: Development of the Impact of Glucose Monitoring on Self-Management Scale

Michael Vallis PhD<sup>a, *</sup>; Lori Berard RN<sup>b</sup>; Emmanuel Cosson MD<sup>c, d</sup>;

Finn Boerlum Kristensen PhD<sup>e</sup>; Fleur Levrat-Guillen PhD<sup>f</sup>; Nicolas Naiditch PhD<sup>g</sup>;

Remi Rabasa-Lhoret MD, PhD<sup>h</sup>; William Polonsky PhD<sup>i</sup>

## Key Messages

* Type 2 diabetes requires engagement in self-management.

* Continuous glucose monitoring technology can facilitate engagement.

* This study validates a scale for assessing engagement.

## ARTICLE INFO

**Article history:**

Received 8 February 2024

Received in revised form

26 June 2024

Accepted 11 July 2024

**Keywords:**

continuous glucose monitoring

motivation

patient-reported outcome

self-management

## ABSTRACT

**Objectives:** Type 2 diabetes (T2D) management requires behavioural engagement to achieve optimal outcomes and continuous glucose monitoring (CGM) technologies may facilitate self-management. In this study we describe the development and validation of a self-report instrument, the Impact of Glucose Monitoring on Self-Management Scale (IGMSS), assessing the impact of device use (primarily CGM but also self-monitored blood glucose [SMBG]) on the capability, motivation, and opportunity to engage in self-management.

**Methods:** Potential items were generated from 3 sources: themes and quotes from 13 adults with T2D motivated by CGM use who participated in a qualitative study; behaviour change theory identifying capability, opportunity, and motivation to self-manage; and expert committee review of items. An initial pool of 42 items were generated describing CGM as promoting personalized knowledge, improved health (Capability), improved relationships, having positive device characteristics (Opportunity), and improved engagement in self-management (Motivation). Based on expert committee consensus, items were written so as to be completed by those using any glucose-sensing device (SMBG and CGM). Psychometric evaluation was conducted with 514 English-speaking Canadians. Scale reduction (22 final items) was completed using item-response distribution, internal consistency, factor analysis, and expert opinion. Construct and convergent validity were evaluated using the Impact of Glucose Monitoring Satisfaction Scale, the Diabetes Self-Management Questionnaire, the Diabetes Distress Scale, the 5-item World Health Organization Well-Being Index, and the Centre for Epidemiology Depression Scale. Test-retest reliability was determined for 130 participants.

**Results:** Internal consistency was high for all scales, ranging from 0.73 to 0.91. Test-retest reliability ranged from 0.58 to 0.79, except for Device Characteristics. Construct and convergent validity indices were

<footnote><sup>a</sup> Family Medicine, Dalhousie University, Halifax, Nova Scotia, Canada</footnote>

<footnote><sup>b</sup> Pink Pearls, Inc, Winnipeg, Manitoba, Canada</footnote>

<footnote><sup>c</sup> AP-HP Hôpitaux Universitaires Paris Seine-Saint-Denis, Avicenne Hospital, Bobigny, France</footnote>

<footnote><sup>d</sup> Equipe de Recherche en Epidémiologie Nutritionnelle, Université Sorbonne Paris Nord and Université Paris Cité, INSERM, INRAE, CNAM, Center of Research in Epidemiology and Statistics, Bobigny, France</footnote>

<footnote><sup>e</sup> Department of Public Health Research Unit of User Perspectives, University of South Denmark, Odense, Denmark</footnote>

<footnote><sup>f</sup> Abbott Diabetes Care, Maidenhead, United Kingdom</footnote>

<footnote><sup>g</sup> Fédération Française des Diabétiques, Paris, Île-de-France, France</footnote>

<footnote><sup>h</sup> Institut de Recherches Cliniques de Montréal and Université de Montréal, Montréal, Québec, Canada</footnote>

<footnote><sup>i</sup> Behavioral Diabetes Institute, San Diego, California, United States</footnote>

<footnote>* Address for correspondence: Michael Vallis PhD, Faculty of Medicine, Dalhousie University, 133 Milsom Street, Halifax, Nova Scotia B3N 3M3, Canada.
Email address: tvallis@dal.ca</footnote>
acceptable. There was substantial overlap between the IGMSS and established measures of CGM satisfaction. IGMSS findings were also predictive of self-management behaviour and emotional functioning.

**Conclusions:** The IGMSS has positive psychometric characteristics and has the potential to screen people with T2D for engagement in diabetes self-management using CGM or any sensing device. Scores can be determined for various aspects of Capability (Personalized Knowledge, Improved Health), Opportunity (Relationships and Device Characteristics), and Motivation.

© 2024 The Author(s). Published by Elsevier Inc. on behalf of Canadian Diabetes Association. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Mots clés:
surveillance du glucose en continu
motivation
autogestion
résultats rapportés par les patients

RÉSUMÉ

**Objectifs** : La gestion du diabète de type 2 (DT2) nécessite un engagement comportemental pour obtenir des résultats optimaux et les technologies de surveillance du glucose en continu (SGC) peuvent faciliter l'autogestion. Cet article décrit le développement et la validation d'un instrument d'auto-évaluation, une Échelle de l'Impact de la Surveillance du Glucose sur l'Autogestion (EISGA): «Impact of Glucose Monitoring on Self-Management Scale», qui évalue l'impact de l'utilisation d'un appareil de mesure (principalement pour la SGC mais aussi l'autosurveillance de la glycémie ASG) sur la capacité, la motivation et la possibilité de s'engager dans l'autogestion.

**Méthodes** : Différents éléments d'évaluation potentiels ont été générés à partir de trois sources distinctes: des thèmes et citations de 13 adultes atteints de DT2 motivés par l'utilisation d'un SGC et ayant participé à une étude qualitative; la théorie du changement de comportement identifiant la capacité, l'opportunité et la motivation à s'autogérer; et l'examen des éléments par un comité d'experts. Un premier ensemble de 42 questions a été généré, décrivant la SGC comme favorisant les connaissances personnalisées, l'amélioration de la santé (Capacité), l'amélioration des relations, les caractéristiques positives de l'appareil (Opportunité) et l'amélioration de l'engagement dans l'autogestion (motivation). Sur la base d'un consensus au sein d'un comité d'experts, les questions ont été rédigées de manière à pouvoir être remplies par les personnes utilisant n'importe quel dispositif de mesure du glucose (ASG et SGC). Une évaluation psychométrique a été réalisée auprès de 514 Canadiens anglophones. La réduction de l'échelle (avec 22 éléments finaux) a été réalisée en utilisant la distribution des réponses aux questions, la cohérence interne, l'analyse factorielle et l'opinion d'experts. La validité de construction et la validité convergente ont été évaluées en utilisant: l'échelle de satisfaction de la surveillance du glucose, le questionnaire d'autogestion du diabète, l'échelle de détresse du diabète, l'indice 5 de bien-être de l'OMS et l'échelle de dépression du Centre d'épidémiologie. La fiabilité test-retest a été déterminée sur 130 participants.

**Résultats** : La cohérence interne était élevée pour toutes les échelles, variant de 0.73 à 0.91. La fiabilité test-retest était comprise entre 0.58 et 0.79, sauf pour les caractéristiques des dispositifs. Les indices de validité de construction et de convergence étaient acceptables. Il y avait un chevauchement important entre l'EISGA et les mesures établies de la satisfaction de la SGC. Les niveaux de l'EISGA ont également permis de prédire le comportement d'autogestion et le fonctionnement émotionnel.

**Conclusions** : L'EISGA présente des caractéristiques psychométriques positives et peut être utilisée pour évaluer l'engagement des personnes atteintes de DT2 dans l'autogestion de leur diabète à l'aide d'un SGC ou de tout autre dispositif de détection. Des scores peuvent être déterminés pour divers aspects de la capacité (connaissances personnalisées, amélioration de la santé), de l'opportunité (relations et caractéristiques de l'appareil) et de la motivation.

© 2024 The Author(s). Published by Elsevier Inc. on behalf of Canadian Diabetes Association. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Introduction

Type 2 diabetes (T2D) is a burdensome chronic disease for both individuals and societies [1]. With projected prevalence rates expected to rise steeply in the near future [1], there is a need to develop strategies to improve management of T2D. Although there are reasons to be optimistic about T2D treatment given the large and growing numbers of effective medical therapies and technologies to support glycemic, cardiovascular, and renal outcomes [2,3], people with T2D face challenges in incorporating diabetes self-management behaviours into other day-to-day life activities. This is reflected in the suboptimal achievement of guideline-recommended targets [4]. The World Health Organization (WHO) suggests that improving diabetes self-management is critical to improving diabetes outcomes [5].

All effective treatments for T2D require behavioural engagement by the person affected [3], which in turn requires motivation to alter behaviour in response to glucose excursions and

clinical recommendations. Medical outcomes are largely mediated by self-management behaviours consistent with medical recommendations, healthy lifestyle behaviours, and diabetes technologies [6].

Our group is interested in exploring the potential of continuous glucose monitoring (CGM) devices to increase motivation for self-management in T2D. The authors are composed on an international team of endocrinologists (E.C., R.R.-L.), psychologists (M.V., W.P.), a diabetes nurse (L.B.), a health technology assessment expert (F.B.), a French Diabetes Society member (N.N.), and industry (F.L.-G.).

Emerging evidence supports the effectiveness of CGM devices in improving glycemic outcomes in people with type 1 diabetes [7] as well as T2D in those using insulin or not [8,9]. Furthermore, existing research has demonstrated that CGM is well received by those with diabetes. The Glucose Monitoring System Satisfaction Survey [10] has been validated for people with T2D and evidence supports the positive experience of using CGM
devices [10]. The items on this scale assess the impact of CGM devices on several dimensions, including emotional and behavioural burden of diabetes, as well as feeling more satisfied and less restricted. Although they provide valuable information, these items do not reveal the ability of the device to motivate increased self-management of diabetes. Our interest is in going beyond satisfaction with the device to assessing the role of the device in enhancing self-management by eliciting the drive to engage in diabetes management.

The methodology of this study is based on several factors. First, we wanted items to represent lived experience. As such, we recently conducted a qualitative study assessing the experience of CGM for those with T2D who found the devices to be a "game-changer" in their ability to self-manage [11]. In this study we generated the following themes: CGM increased personalized knowledge of diabetes self-management behaviours, allowing participants to clearly see the connection between their behaviour and glycemic response, in a manner that led to self-perceived improved health; CGM improved participants' relationships with their HCPs and empowered them to feel like equal partners. Click or tap here to enter text. Social relationships were also improved, with the technology cueing more informed discussion for participants; and self-management motivation, which reflected greater engagement in self-management with CGM relative to self-monitored blood glucose (SMBG) fingerstick testing, which was perceived as negative [11]. Quotes illustrating these themes were used as potential items for the Impact of Glucose Monitoring on Self-Management Scale (IGMSS).

We also used a contemporary behaviour change theory to create potential items and categorize items generated from lived experience. Specifically, we used the Capability plus Opportunity plus Motivation lead to Behaviour (COM-B) model [12,13]. Quotes underlying the items and constructs generated from the qualitative study were categorized as follows: Capability (Personalized Knowledge, Improved Health Outcomes); Opportunity (Improved Relationships With Health-care Providers [HCPs] and others, Device Characteristics); and Motivation (increased motivation). Third, items were reviewed by the author team to ensure they reflected contemporary clinical knowledge. Specifically, we determined that the best use of the scale was to word items so that the scale could be completed by those using SMBG as well as CGM. A total of 42 items were generated (Table 1). The purpose of this study was to conduct a psychometric analysis of these items to create a valid, reliable, and short self-report scale that measures capability, opportunity, and motivation to self-manage T2D using CGM technology. This was done using an iterative process in accordance with the appropriate guidance from the United States Food and Drug Administration [14]. We call this new instrument the Impact of Glucose Monitoring on Self-management Scale.

## Methods

### Participants

To conduct a valid psychometric analysis of the potential IGMSS items, we set out to recruit a minimum of 10 respondents per scale item. An online survey company (Inet International, Thornhill, Ontario, Canada) used a consumer panel of approximately of 300,000 individuals to recruit a geographically representative sample of Canadians living with T2D and using CGM devices. A total of 514 participants completed the survey scales between July 1 and July 27, 2022. All participants were asked if they were willing to retake the IGMSS, and those agreeing

(n=130) completed the IGMSS on a second occasion (the test–retest reliability sample). This study was approved by the research ethics board of Nova Scotia Health (No. 1026933, July 15, 2021).

### Initial item generation

The specific quotes that described the themes from the qualitative study were used to create items for the IGMSS. Items were scored on a 5-point Likert scale assessing degree of agreement (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). A total of 42 initial items were generated and were organized using the COM-B model [13] (Table 1), where Capability centres on themes of improved personalized knowledge and improved health; Opportunity centres on themes of improved HCP relationships, improved social relationships, and device characteristics; and Motivation centres on the theme of improved self-management motivation.

### Measures

In addition to the generated items described, participants reported on several demographic characteristics, including: diabetes type (a screening question); year of diagnosis; gender; province of residence; age; type of CGM device used (Freestyle Libre, Dexcom, Medtronic, or other); length of use of CGM device (1 to 3 months, 3 to 6 months, ≥6 months); and diabetes management regimen (lifestyle only, antihyperglycemic agent—oral or glucagon-like protein-1 [GLP-1], basal insulin, multiple daily injections, or pump use). In addition to the newly developed 42 IGMSS items, participants completed the following validated self-report scales:

*Glucose Monitoring System Satisfaction Survey (GMSS) [8]: This 18-item scale yields a total score and 4 subscale scores: emotional burden, behavioural burden, openness, and worthwhileness. It provides a comprehensive assessment of glucose monitoring device satisfaction. This scale was used to assess concurrent validity; we predicted that this scale would assess a similar construct to the IGMSS, and the total score would have a correlation of r > 0.4.

The measures described next were included to assess convergent validity—that is, that the correlation between measures (total scores) would be moderate (r ~ 0.4).

*Diabetes Self-Management Questionnaire (DSMQ) [12]: This 16-item scale assesses glucose management, dietary control, physical activity, and use of health care. It provides an efficient assessment of self-care behaviours associated with glycemic management.

*Diabetes Distress Scale (DDS) [13]: This 17-item scale assesses worries and concerns specifically related to diabetes. It yields a total score and 4 subscales scores, including emotional burden, regimen distress, provider-related distress, and social support distress. It has also been shown to be a good marker of diabetes-related quality of life (QOL).

*WHO Well-Being Index (WHO-5) [14]: This 5-item QOL instrument has been validated for use in diabetes.

*Centre for Epidemiological Studies Depression (CES-D) Scale [15]: This 20-item self-report scale has been validated as a measure of the major symptoms of depression. It yields a single total score (range 0 to 60) with an established cutoff of >16 for likely depression.

Finally, we assessed discriminant validity by correlating the IMGSS with a measure not likely to be associated with the scale. We chose diabetes duration and predicted low correlations (i.e. <0.20).
<table><caption>**Table 1**</caption><caption>IGMSS items: Original and final items</caption><thead><tr><th>Original 42 items</th><th>Revised final scale items (N=22)</th></tr></thead><tbody><tr><td><strong>Capability</strong><br><strong>Personalized Knowledge</strong><br>Understand how specific foods (type, amount, preparation, etc) directly affect my glucose levels<br>Understand how exercise (type, duration, intensity) directly affects my glucose levels<br>Understand how stress (intensity, duration) directly affects my glucose levels<br>Learn how I can adjust my behaviour to keep glucose readings within range<br>Know if my glucose level is trending up or down at any moment<br>See the larger picture of how my own efforts can keep my diabetes under better control<br>Avoid highs and lows by using the trend values or using the alarms<br><strong>Improved Health</strong><br>Improve my A1C level (the blood test that measures 3-month control)<br>Improve my general health<br>To stay safe from problems with low blood sugar<br>Using the sensing device has become automatic for me<br><strong>Opportunity</strong><br><strong>Improved HCP Relationships</strong><br>Have more useful conversations with my health-care provider(s) about diabetes management<br>Have a better relationship with my health-care provider(s)<br>Receive better care from my health-care provider(s)<br>Receive more efficient care since diabetes visits don't take so long<br><strong>Improved Social Relationships</strong><br>Improve the conversation about diabetes with the other people in my life<br>Feel more cared for because others can view and respond to my glucose levels if I need help<br>To have positive conversations about diabetes with others when they ask questions<br>I have support from my family to use the sensing device for managing my diabetes<br>People whose opinion I value support me to use the sensing device for managing my diabetes<br>I have the all the resources I need (money, time) to continue using the sensing device<br><strong>Device Characteristics</strong><br>My health insurance will not cover all the costs<br>It is uncomfortable to wear (e.g. bothers my skin, interferes with clothing, etc)<br>It is more visible than I want it to be<br>It is not always as accurate as it should be<br>I don't feel comfortable sharing all my data with my healthcare providers<br>My health-care providers are not really using the data from my device<br>It keeps falling off<br>Because it is visible, I don't feel comfortable with other people knowing I have diabetes<br>It reminds me that I have diabetes<br>I am having to think about my diabetes more than I want to<br><strong>Motivation</strong><br><strong>Improved Self-management Motivation</strong><br>To be more engaged (involved) in controlling my glucose levels<br>Take control of my diabetes<br>To want to take action to better manage my diabetes<br>More confident in managing hypoglycemia<br>More optimistic about my diabetes<br>Finding that life with diabetes is easier<br>More confident that I can manage diabetes<br>More confident in my everyday life<br>More hopeful about the future<br>I intend to continue to use a sensing device to manage my diabetes<br>I believe that if I stopped using a sensing device my diabetes control would be worse</td><td><strong>Capability</strong><br>Personalized Knowledge<br>To understand how specific foods, exercises, and stress directly affects my glucose levels<br>To learn how I can adjust my behaviour to keep glucose readings within range<br>To know if my glucose level is trending up or down at any moment<br>I avoid highs and lows by using the trend values or using the alarms<sup>*</sup><br><strong>Improved Health</strong><br>To improve my A1C level (the blood test that measures 3-month control)<br>To improve my general health<br>To stay safe from problems with glucose levels that are either too low or too high<br><strong>Opportunity</strong><br><strong>Improved HCP Relationships</strong><br>To have more useful conversations with my health-care provider(s) about diabetes management<br>To receive better care from my health-care provider(s)<br><strong>Improved Social Relationships</strong><br>To improve the conversations about diabetes with the important people in my life<br>To feel more cared for because others can view and respond to my glucose levels if I need help<br><strong>Device Characteristics</strong><br>To feel comfortable sharing my glucose data with my health-care providers<br>It provides me with reliable information<br>It is comfortable to use<br>Although it can be visible, I feel comfortable with other people recognizing it and realizing that I have diabetes<sup>*</sup><br>I don't mind that wearing it reminds me that I have diabetes<sup>*</sup><br><strong>Motivation</strong><br><strong>Improved Self-management Motivation</strong><br>To become more engaged (involved) in controlling my glucose levels<br>To take action to better manage my diabetes<br>To become more optimistic about my diabetes<br>To make life with diabetes is easier<br>To feel more confident that I can manage diabetes<br>I believe that if I stopped using a sensing device my diabetes control would be worse</td></tr></tbody></table>

A1C, glycated hemoglobin.

**Notes:** The first column (left-hand side) in the table shows the complete list of main themes and items generated from structured interviews with 13 adults with type 2 diabetes who used continuous glucose monitoring as part of the "game-changer" qualitative study [1]. These themes and items were then reduced and consolidated using factor analysis in a manner that allowed items to be reduced without loss of information. The final list of items within the main themes is shown in the second column (right-hand side). Items in italics were deleted from final scale. Bolded items are final, retained items.

* Item completed only by those using a continuous glucose monitor.
## Analyses

**Scale development:** To ensure that the lived experience and behaviour change theory were retained in our analyses, items were evaluated separately within the Capability, Opportunity, and Motivation domains of the COM-B model. Means and standard deviations, internal consistencies (determined by Cronbach's alpha [α] statistic), item-total correlations, and factor analyses within each domain were calculated. Item reduction was also determined. First, all items within each domain (Capability, Opportunity, Motivation) were submitted to an exploratory factor analysis. Factor analysis (in our case, principle components with varimax rotation using SPSS version 29 [IBM Corp, Armonk, New York, United States]) is a statistical technique that identifies common variance among multiple variables and reduces a large number of items into a lower number of factors. Items within factors measure the same construct, facilitating item reduction without loss of information. Second, item selection was guided by examining the frequency distribution of item responses, as well as mean, mode, median, and skewness of the items. Third, the contribution of each item to the total score was evaluated by comparing Cronbach's α statistic when the item was included and when the item was excluded from calculation. Items not performing well by any of these criteria were deleted. Once items were evaluated psychometrically, they were submitted to an expert panel (the authors) for item revision, elimination, or addition. Items were reviewed for clarity and ease of understanding, and a consensus approach was taken to select items. Finally, the stability of the scale (test–retest reliability calculated by the intraclass correlation coefficient [ICC]) was calculated using a subsample of 130 participants who agreed to complete the IGMSS on a second occasion.

**Validity analyses:** As just described, concurrent validity is the ability of the scale to correlate with different measures of the same construct, in this case using the GMSS. Convergent validity was evaluated by correlating IGMSS scores with diabetes self-care behaviours using the DSMQ. In addition, correlations were calculated between IGMSS scores and diabetes-related distress, depression, and QOL, using the DDS, the CES-D, and the WHO-5. Finally, divergent validity, which assesses the relationship between 2 constructs thought to have little relationship to each other, was calculated by comparing the IGMSS score with duration of T2D.

**Sample scale characteristics:** To assess the experience of CGM using our framework, we examined the proportion of respondents who either agreed or disagreed with the IGMSSs (e.g. What proportion of respondents agreed that CGM improved personalized knowledge of diabetes self-management?). We calculated this by recoding the responses. Mean scores were recoded as follows: 1 to 2.5 was recoded to “disagree” and 3.5 to 5 to “agree.” Those scoring between 2.5 and 3.5 were not used in these recoded analyses. This allowed us to examine the proportion of respondents who experienced CGM as improving self-management motivation on scale constructs.

## Results

### Participants

Demographic characteristics of the 514 respondents are presented in Table 2. Slightly more men were recruited than women, with the geographic distribution of respondents matching the Canadian population (by design). On average, respondents had a mean age of 58.8 years and had been living with T2D for a mean of

14.6 years. Approximately half of the respondents were managed using oral agents or GLP-1 receptor antagonists, with smaller numbers using basal insulin (22.6%) or multiple daily injections (19.3%), and 8% managing diabetes using lifestyle alone. Just over half of respondents were using a Freestyle Libre device, with 10.5% using a Dexcom device and 1.4% a Medtronic device. Most respondents (73.9%) reported using CGM for >6 months, 10.7% reported 3- to 6-month use, and 15.4% had been using CGM for 1 to 3 months.

### Item reduction and selection

**Capability:** The 11 items of the Capability subscale (Table 3) all loaded on a single factor, accounting for 59.1% of variance (see Supplementary Table 1 for factor analysis results). The mean scores for each item clustered around 4 (range 3.79 to 4.10) and all items were negatively skewed (range −0.563 to −0.879). For each item, all response options were used. Internal consistency (Cronbach's α) for all 11 items was α=0.930. When any item was removed, internal consistency remained above α=0.92, suggesting that no item made a stronger contribution to the total than any other item. From a psychometric perspective, all items performed well. As a result, item reduction was based on rational grounds, such that items from each qualitative theme (Improved Personalized Knowledge, Improved Health) were retained. The expert committee recommended combining the first 3 items (understanding how food, exercise, and stress directly affects glucose) into a single item (Understand how specific foods, exercise,

<table><caption>**Table 2**
Characteristics of survey respondents (N=514)</caption><thead><tr><th>Characteristic</th><th>N (%)</th><th>Mean (SD)</th></tr></thead><tbody><tr><td>Gender</td><td></td><td></td></tr><tr><td>Male</td><td>289 (56.2%)</td><td></td></tr><tr><td>Female</td><td>223 (43.4%)</td><td></td></tr><tr><td>Nonbinary</td><td>2 (0.4%)</td><td></td></tr><tr><td>Age, years</td><td></td><td>58.8 (14.5)</td></tr><tr><td>Diabetes duration, years</td><td></td><td>14.6 (10.9)</td></tr><tr><td>Location</td><td></td><td></td></tr><tr><td>British Columbia</td><td>61 (11.9%)</td><td></td></tr><tr><td>Alberta</td><td>63 (12.3%)</td><td></td></tr><tr><td>Saskatchewan</td><td>17 (3.3%)</td><td></td></tr><tr><td>Manitoba</td><td>26 (5.1%)</td><td></td></tr><tr><td>Ontario</td><td>250 (48.6%)</td><td></td></tr><tr><td>Quebec</td><td>46 (8.9%)</td><td></td></tr><tr><td>New Brunswick</td><td>13 (2.5%)</td><td></td></tr><tr><td>Nova Scotia</td><td>17 (3.3%)</td><td></td></tr><tr><td>Prince Edward Island</td><td>3 (0.6%)</td><td></td></tr><tr><td>Newfoundland</td><td>18 (3.5%)</td><td></td></tr><tr><td>Nunavut</td><td>—</td><td></td></tr><tr><td>Yukon</td><td>—</td><td></td></tr><tr><td>Use CGM</td><td></td><td></td></tr><tr><td>Yes</td><td>514 (100%)</td><td></td></tr><tr><td>No</td><td>0 (0.0%)</td><td></td></tr><tr><td>CGM device type</td><td></td><td></td></tr><tr><td>FSL</td><td>185 (36.0%)</td><td></td></tr><tr><td>FSL2</td><td>120 (23.3%)</td><td></td></tr><tr><td>Dexcom</td><td>54 (10.5%)</td><td></td></tr><tr><td>Medtronic</td><td>7 (1.4%)</td><td></td></tr><tr><td>Other</td><td>148 (28.8%)</td><td></td></tr><tr><td>CGM duration, months</td><td></td><td></td></tr><tr><td>1–3</td><td>79 (15.4%)</td><td></td></tr><tr><td>3–6</td><td>55 (10.7%)</td><td></td></tr><tr><td>>6</td><td>380 (73.9%)</td><td></td></tr><tr><td>Management</td><td></td><td></td></tr><tr><td>Lifestyle</td><td>41 (8.0%)</td><td></td></tr><tr><td>Oral or GLP-1</td><td>258 (50.2%)</td><td></td></tr><tr><td>Basal insulin</td><td>116 (22.6%)</td><td></td></tr><tr><td>MDI</td><td>99 (19.3%)</td><td></td></tr></tbody></table>

CGM, continuous glucose monitoring; FSL, Freestyle Libre; GLP-1, glucagon-like protein-1; MDI, multiple daily injections; SD, standard deviation.
<table><caption>**Table 3**
Psychometric characteristics of IGMSS</caption><thead><tr><th></th><th>Mean score</th><th>Skewness</th><th>α item removed</th></tr></thead><tbody><tr><td colspan="4"><strong>Capability items</strong></td></tr><tr><td colspan="4">(Cronbach's α=0.930): Using my glucose-sensing device has helped me to:</td></tr><tr><td>Understand how specific foods (type, amount, preparation, etc) directly affect my glucose levels</td><td>4.10</td><td>-0.814</td><td>0.923</td></tr><tr><td>Understand how exercise (type, duration, intensity) directly affects my glucose levels</td><td>3.93</td><td>-0.791</td><td>0.924</td></tr><tr><td>Understand how stress (intensity, duration) directly affects my glucose levels</td><td>3.78</td><td>-0.917</td><td>0.927</td></tr><tr><td>Learn how I can adjust my behaviour to keep glucose readings within range</td><td>4.01</td><td>-0.681</td><td>0.921</td></tr><tr><td>Know if my glucose level is trending up or down at any moment</td><td>4.10</td><td>-0.973</td><td>0.923</td></tr><tr><td>See the larger picture of how my own efforts can keep my diabetes under better control</td><td>4.06</td><td>-0.807</td><td>0.920</td></tr><tr><td>Avoid highs and lows by using the trend values or using the alarms</td><td>3.79</td><td>-0.563</td><td>0.924</td></tr><tr><td>Improve my A1C level (the blood test that measures 3-month control)</td><td>3.98</td><td>-0.736</td><td>0.923</td></tr><tr><td>Improve my general health</td><td>4.03</td><td>-0.675</td><td>0.921</td></tr><tr><td>Stay safe from problems with low blood sugars</td><td>3.99</td><td>-0.879</td><td>0.925</td></tr><tr><td>Using the sensing device has become automatic for me</td><td>3.92</td><td>-0.839</td><td>0.927</td></tr><tr><td colspan="4"><strong>Opportunity items</strong></td></tr><tr><td colspan="4">Factor A (Cronbach's α=0.91): Using my glucose-sensing device has helped me to:</td></tr><tr><td>Have more useful conversations with my health-care provider(s) about diabetes management</td><td>3.93</td><td>-0.791</td><td>0.900</td></tr><tr><td>Have a better relationship with my health-care provider(s)</td><td>3.75</td><td>-0.544</td><td>0.892</td></tr><tr><td>Receive better care from my health-care provider(s)</td><td>3.78</td><td>-0.753</td><td>0.892</td></tr><tr><td>Receive more efficient care since diabetes visits don't take so long</td><td>3.68</td><td>-0.551</td><td>0.896</td></tr><tr><td>Improve the conversation about diabetes with the other people in my life</td><td>3.73</td><td>-0.689</td><td>0.896</td></tr><tr><td>Feel more cared for because others can view and respond to my glucose levels if I need help</td><td>3.66</td><td>-0.587</td><td>0.898</td></tr><tr><td>To have positive conversations about diabetes with others when they ask questions</td><td>3.77</td><td>-0.791</td><td>0.900</td></tr><tr><td colspan="4">Factor B (Cronbach's α=0.893): Regarding my glucose-sensing device:</td></tr><tr><td>My health insurance will not cover all the costs</td><td>3.11</td><td>-0.049</td><td>0.893</td></tr><tr><td>It is uncomfortable to wear (e.g. falls off, bothers my skin, interferes with clothing, more visible than I like, etc); revised: It is comfortable to use</td><td>3.28</td><td>-0.111</td><td>0.877</td></tr><tr><td>It is more visible than I want it to be</td><td>3.15</td><td>-0.056</td><td>0.877</td></tr><tr><td>It is not always as accurate as it should be; revised: It provides me with reliable information</td><td>3.07</td><td>-0.045</td><td>0.877</td></tr><tr><td>I don't feel comfortable sharing all my data with my health-care providers; revised: I feel comfortable sharing my glucose data with my health-care providers' management</td><td>3.71</td><td>-0.590</td><td>0.889</td></tr><tr><td>My health-care providers are not really using the data from my device</td><td>3.25</td><td>-0.150</td><td>0.881</td></tr><tr><td>It keeps falling off</td><td>3.35</td><td>-0.229</td><td>0.884</td></tr><tr><td>Because it is visible, I don't feel comfortable with other people knowing I have diabetes; revised: Although it can be visible, I feel comfortable with other people recognizing it and realizing I have diabetes</td><td>3.39</td><td>-0.270</td><td>0.884</td></tr><tr><td>It reminds me that I have diabetes; revised: I don't mind that wearing it reminds me I have diabetes</td><td>2.91</td><td>0.215</td><td>0.878</td></tr><tr><td>I am having to think about my diabetes more than I want to</td><td>3.08</td><td>0.027</td><td>0.884</td></tr><tr><td colspan="4">Factor C (Cronbach's α=0.721): Regarding using a glucose-sensing device:</td></tr><tr><td>I have support from my family to use the sensing device for managing my diabetes</td><td>3.74</td><td>-0.686</td><td>0.539</td></tr><tr><td>People whose opinion I value support me to use the sensing device for managing my diabetes</td><td>3.73</td><td>-0.632</td><td>0.531</td></tr><tr><td>I have the all the resources I need (money, time) to continue using the sensing device</td><td>3.49</td><td>-0.589</td><td>0.820</td></tr><tr><td colspan="4"><strong>Motivation items</strong></td></tr><tr><td colspan="4">Factor A (Cronbach's α=812): Using my glucose-sensing device has helped me to:</td></tr><tr><td>Be more engaged (involved) in controlling my glucose levels</td><td>4.04</td><td>-0.869</td><td>0.777</td></tr><tr><td>Take control of my diabetes</td><td>4.10</td><td>-0.755</td><td>0.830</td></tr><tr><td>To take action to better manage my diabetes</td><td>4.10</td><td>-0.771</td><td>0.770</td></tr><tr><td colspan="4">Factor B (Cronbach's alpha=0.812): Because of using my glucose-sensing device I am:</td></tr><tr><td>More confident in managing hypoglycemia</td><td>3.82</td><td>-0.661</td><td>0.899</td></tr><tr><td>More optimistic about my diabetes</td><td>3.68</td><td>-0.583</td><td>0.897</td></tr><tr><td>Finding that life with diabetes is easier</td><td>3.65</td><td>-0.670</td><td>0.905</td></tr><tr><td>More confident that I can manage diabetes</td><td>3.86</td><td>-0.780</td><td>0.897</td></tr><tr><td>More confident in my everyday life</td><td>3.70</td><td>-0.611</td><td>0.899</td></tr><tr><td>More hopeful about the future</td><td>3.65</td><td>-0.579</td><td>0.898</td></tr><tr><td>Regarding using a glucose-sensing device:</td><td>3.82</td><td>-0.661</td><td>0.899</td></tr><tr><td>I intend to continue to use a sensing device to manage my diabetes</td><td>3.91</td><td>-1.016</td><td>0.914</td></tr><tr><td>I believe that if I stopped using a sensing device my diabetes control would be worse</td><td>3.49</td><td>-0.505</td><td>0.925</td></tr></tbody></table>

Note: Italicized items were dropped from final scale; bolded items were retained.

and stress directly affect my glucose levels). The final 7 items assessing Capability (4 items from improved personalized knowledge and 3 items from improved health) are presented in bold in Table 1 (deleted items are shown in italics/nonbold on the left-hand side of the table).

**Opportunity:** The factor analysis of the 20 items from the Opportunity scale resulted in 3 factors (Table 3 and Supplementary Table 1). One factor included the items of the improved social relationships and improved relationships with HCP items. A second factor included all items of the Device Characteristics theme. The third factor included the 3 items on support and resources to continue use of the sensing device.

For the 7 items in the improved relationships factor, the mean scores ranged from 3.66 to 3.93, and all response options were selected for all items and all items were negatively skewed (−0.544 to −0.791). Internal consistency of all 7 items was α=0.910 and when any item was removed the internal consistency remained above α=0.891, suggesting that no item made a stronger contribution than any other item. So, item reduction was based on rational grounds (see the 4 retained items in Table 1).

For the Device Characteristics factor, mean scores for each item ranged from 2.91 to 3.71, and most items were mildly negatively skewed (−0.049 to −0.270). All response options were used for all items. Internal consistency of all 10 items was α=0.893 and when any item was removed internal consistency remained above
$\alpha$=0.877, suggesting that no item made a stronger contribution than any other item. From a psychometric perspective, all items performed well, so item reduction was based on expert committee review. The 3 separate items, *It is uncomfortable to wear (e.g. bothers my skin, interferes with clothing, etc)*, *It is more visible than I want it to be*, and *It keeps falling off*, were reformulated to a single item: *It is comfortable to use*. Finally, it was decided that all items should be reformulated such that anyone monitoring their blood glucose levels could use the scale, including those using SMBG. As such, negatively worded items were reframed to positive items. Retained items are presented in bold in Table 1 (5 items).

For the 3 items in the support and resources factor, the mean scores ranged from 3.49 to 3.74 and all items were negatively skewed (−0.589 to −0.686), with all item response options used for all items. The internal consistency of the 3 items was $\alpha$=0.721. When the item *I have all the resources I need (money, time) to continue using the sensing device* was removed the internal consistency increased to $\alpha$=0.820. When either of the other 2 items were removed, internal consistency decreased to $\alpha$=0.530 and $\alpha$=0.539, suggesting that this item should be seen as different from the other 2 items. Upon expert committee review, it was decided to delete all 3 items because they accounted for such little variance in the factor analysis and because they assess experiences outside of the individual (other people or external resources that may be determined by sociocultural factors).

**Motivation:** Finally, the factor analysis of 11 items of the Motivation scale yielded 2 factors (Table 3 and Supplementary Table 1). The first factor was composed of 8 items reflecting positive emotions associated with self-management. The second factor was composed of 3 behavioural engagement items.

For the positive emotions factor, the mean item scores ranged from 3.45 to 3.91, with all response options selected for all items and negatively skewed (−0.50 to −1.02). The internal consistency of

these 8 items was $\alpha$=0.915 and when any item was removed the internal consistency remained above $\alpha$=0.897, suggesting that no item made a stronger contribution to the total than any other, so items were reduced on rational grounds (see the 4 retained items in Table 1).

For the behavioural engagement factor, mean item scores ranged from 4.04 to 4.10, with all response options selected for each item and all negatively skewed (−0.76 to −0.87). The internal consistency of these 3 items was $\alpha$=0.852 and when any item was removed the internal consistency remained above $\alpha$=0.770, suggesting that no item made a stronger contribution to the total than any other item. The final 2 items are given in Table 1.

Table 4 shows the item characteristics of the final scales after factor analysis. The internal consistency of these scales and subscales were all high, ranging from $\alpha$=0.734 (Improved Social Relationships) to $\alpha$=0.909 (Capability).

### Test–retest reliability

A subset of 130 respondents were recruited to repeat the IGMSS approximately 3 months after initial completion. Reliability was calculated using the ICC, which considers absolute values as well as correlation between measures (Table 5). All scales and subscales demonstrated moderate to good test–retest reliability, with ICCs ranging from 0.576 to 0.786. The exception was for the Device Characteristics subscale, which showed a negative relationship between administrations of the scale (−0.53), due to significant increases in positive experiences with the device over time.

### Validity analyses

Construct validity was confirmed by demonstrating a significant interrelationship between the IGMSS with the GMSS, a measure of glucose-monitoring device satisfaction (Table 5). As predicted,

<table><caption>**Table 4**
Final scale item characteristics after item reduction (N=514)</caption><thead><tr><th rowspan="2"></th><th colspan="3">Capability</th><th colspan="4">Opportunity</th><th rowspan="2">Motivation<br/>Improved Self-<br/>management</th></tr><tr><th>Overall</th><th>Personalized<br/>Knowledge</th><th>Improved<br/>Health</th><th>Overall</th><th>Improved HCP<br/>Relationships</th><th>Improved Social<br/>Relationships</th><th>Device<br/>Characteristics</th></tr></thead><tbody><tr><td>Scale descriptives</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Mean</td><td>3.97</td><td>3.96</td><td>4.00</td><td>3.50</td><td>3.86</td><td>3.69</td><td>3.27</td><td>3.80</td></tr><tr><td>SD</td><td>0.66</td><td>0.67</td><td>0.70</td><td>0.59</td><td>0.82</td><td>0.82</td><td>0.89</td><td>0.67</td></tr><tr><td>No. of items</td><td>7</td><td>4</td><td>3</td><td>9</td><td>2</td><td>2</td><td>5</td><td>6</td></tr><tr><td>Cronbach's α</td><td>0.909</td><td>0.854</td><td>0.792</td><td>0.724</td><td>0.783</td><td>0.734</td><td>0.815</td><td>0.847</td></tr><tr><td>Gender</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Male</td><td>3.94</td><td>3.92</td><td>3.97</td><td>3.64</td><td>3.89</td><td>3.73</td><td>3.30</td><td>3.87</td></tr><tr><td>Female</td><td>3.99</td><td>4.00</td><td>4.05</td><td>3.50</td><td>3.82</td><td>3.68</td><td>3.17</td><td>3.88</td></tr><tr><td>Treatment</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Lifestyle</td><td>3.97</td><td>4.04</td><td>4.10</td><td><strong>3.18</strong><sup>*</sup></td><td>3.90</td><td>3.68</td><td><strong>2.67</strong><sup>*</sup></td><td>3.87</td></tr><tr><td>Oral</td><td>3.92</td><td>3.94</td><td>4.01</td><td>3.51</td><td>3.85</td><td>3.73</td><td>3.30</td><td>3.85</td></tr><tr><td>Basal</td><td>3.98</td><td>3.96</td><td>3.97</td><td>3.50</td><td>3.87</td><td>3.71</td><td>3.27</td><td>3.90</td></tr><tr><td>MDI</td><td>4.01</td><td>3.96</td><td>3.96</td><td>3.58</td><td>3.83</td><td>3.65</td><td>3.44</td><td>3.90</td></tr><tr><td>Length of CGM use</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>1–3 months</td><td>3.87</td><td>3.96</td><td>3.94</td><td>3.44</td><td>3.80</td><td>3.61</td><td>3.23</td><td>3.84</td></tr><tr><td>3–6 months</td><td>3.87</td><td>3.88</td><td>3.91</td><td><strong>3.19</strong><sup>*</sup></td><td><strong>3.63</strong></td><td>3.57</td><td><strong>2.87</strong><sup>*</sup></td><td>3.77</td></tr><tr><td>>6 months</td><td>3.99</td><td>3.96</td><td>4.03</td><td>3.55</td><td>3.90</td><td>3.75</td><td>3.34</td><td>3.98</td></tr><tr><td>Diabetes duration pre-CGM</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td><2 years</td><td>3.86</td><td>3.85</td><td>3.97</td><td>3.48</td><td>3.80</td><td>3.62</td><td>3.32</td><td>3.74</td></tr><tr><td>>2 years</td><td>3.99</td><td>3.99</td><td>4.01</td><td>3.50</td><td>3.87</td><td>3.73</td><td>3.26</td><td>3.91</td></tr><tr><td>Correlations with IGMSS</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Diabetes duration</td><td>0.007</td><td>0.024</td><td>-0.015</td><td><strong>0.109</strong><sup>*</sup></td><td>-0.010</td><td>-0.059</td><td><strong>0.156</strong><sup>*</sup></td><td>0.005</td></tr><tr><td>Age</td><td>-0.030</td><td>-0.027</td><td>-0.030</td><td><strong>0.165</strong><sup>*</sup></td><td>0.020</td><td>-0.084</td><td><strong>0.223</strong><sup>*</sup></td><td>-0.025</td></tr></tbody></table>

CGM, continuous glucose monitoring; HCP, health-care professional; IGMSS, Impact of Glucose Monitoring on Self-Management Scale; MDI, multiple daily injections; SD, standard deviation.

Note: Bolded statistics indicate statistical significance. For Treatment and Length of CGM use significant differences are between groups (lifestyle/oral/basal/MDI or 1–3 months/3–6 months/ >6 months). For diabetes duration and age significance reflects correlations between measures and GMSS.

* p<0.01.

† p<0.001.
<table><caption>**Table 5**
Test-retest reliability and validity indices for the IGMSS</caption><thead><tr><th></th><th>Capability</th><th>Personalized Knowledge</th><th>Improved Health</th><th>Opportunity</th><th>Improved HCP Relationships</th><th>Improved Social Relationships</th><th>Device Characteristics</th><th>Motivation Improved Self-management</th></tr></thead><tbody><tr><td>Test-retest reliability ICC<sup>*</sup> (N=130)</td><td><strong>0.721</strong></td><td><strong>0.732</strong></td><td><strong>0.610</strong></td><td><strong>0.576</strong></td><td><strong>0.681</strong></td><td><strong>0.688</strong></td><td><strong>-0.530</strong></td><td><strong>0.786</strong></td></tr><tr><td>Glucose monitoring system satisfaction</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Total score</td><td><strong>0.378</strong></td><td><strong>0.372</strong></td><td><strong>0.352</strong></td><td><strong>0.685</strong></td><td><strong>0.267</strong></td><td><strong>0.273</strong></td><td><strong>0.594</strong></td><td><strong>0.472</strong></td></tr><tr><td>Emotional burden</td><td><strong>-0.159</strong></td><td><strong>-0.161</strong></td><td><strong>-0.143</strong></td><td><strong>-0.540</strong></td><td><strong>-0.058</strong></td><td><strong>-0.053</strong></td><td><strong>-0.609</strong></td><td><strong>-0.198</strong></td></tr><tr><td>Behavioural burden</td><td><strong>-0.208</strong></td><td><strong>-0.211</strong></td><td><strong>-0.185</strong></td><td><strong>-0.567</strong></td><td><strong>-0.108</strong></td><td><strong>-0.095</strong></td><td><strong>-0.608</strong></td><td><strong>-0.294</strong></td></tr><tr><td>Openness</td><td><strong>0.407</strong></td><td><strong>0.379</strong></td><td><strong>0.408</strong></td><td><strong>0.297</strong></td><td><strong>0.389</strong></td><td><strong>0.469</strong></td><td><strong>0.040</strong></td><td><strong>0.584</strong></td></tr><tr><td>Worthwhileness</td><td><strong>0.470</strong></td><td><strong>0.474</strong></td><td><strong>0.423</strong></td><td><strong>0.498</strong></td><td><strong>0.366</strong></td><td><strong>0.312</strong></td><td><strong>0.350</strong></td><td><strong>0.494</strong></td></tr><tr><td>Diabetes Self-Management Questionnaire</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Total score</td><td><strong>0.181</strong></td><td><strong>0.175</strong></td><td><strong>0.173</strong></td><td><strong>0.347</strong></td><td><strong>0.162</strong></td><td><strong>0.134</strong></td><td><strong>0.308</strong></td><td><strong>0.215</strong></td></tr><tr><td>Glucose management</td><td><strong>0.197</strong></td><td><strong>0.183</strong></td><td><strong>0.197</strong></td><td><strong>0.330</strong></td><td><strong>0.129</strong></td><td><strong>0.101</strong></td><td><strong>0.312</strong></td><td><strong>0.227</strong></td></tr><tr><td>Dietary control</td><td><strong>0.167</strong></td><td><strong>0.169</strong></td><td><strong>0.150</strong></td><td><strong>0.150</strong></td><td><strong>0.167</strong></td><td><strong>0.184</strong></td><td><strong>0.051</strong></td><td><strong>0.144</strong></td></tr><tr><td>Physical activity</td><td><strong>0.125</strong></td><td><strong>0.132</strong></td><td><strong>0.104</strong></td><td><strong>0.198</strong></td><td><strong>0.171</strong></td><td><strong>0.161</strong></td><td><strong>0.117</strong></td><td><strong>0.182</strong></td></tr><tr><td>Use of health care</td><td><strong>-0.002</strong></td><td><strong>-0.016</strong></td><td><strong>0.017</strong></td><td><strong>0.264</strong></td><td><strong>-0.019</strong></td><td><strong>-0.085</strong></td><td><strong>0.357</strong></td><td><strong>0.034</strong></td></tr><tr><td>Diabetes Distress Scale</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Total</td><td><strong>-0.002</strong></td><td><strong>-0.009</strong></td><td><strong>0.015</strong></td><td><strong>-0.352</strong></td><td><strong>-0.024</strong></td><td><strong>-0.008</strong></td><td><strong>-0.413</strong></td><td><strong>-0.029</strong></td></tr><tr><td>Emotional burden</td><td><strong>0.041</strong></td><td><strong>-0.024</strong></td><td><strong>0.059</strong></td><td><strong>-0.294</strong></td><td><strong>0.028</strong></td><td><strong>0.005</strong></td><td><strong>-0.367</strong></td><td><strong>-0.009</strong></td></tr><tr><td>Regimen distress</td><td><strong>-0.019</strong></td><td><strong>-0.023</strong></td><td><strong>-0.012</strong></td><td><strong>-0.293</strong></td><td><strong>-0.031</strong></td><td><strong>-0.025</strong></td><td><strong>-0.341</strong></td><td><strong>-0.039</strong></td></tr><tr><td>Provider distress</td><td><strong>-0.050</strong></td><td><strong>-0.055</strong></td><td><strong>-0.039</strong></td><td><strong>-0.398</strong></td><td><strong>-0.112</strong></td><td><strong>-0.049</strong></td><td><strong>-0.332</strong></td><td><strong>-0.059</strong></td></tr><tr><td>Support distress</td><td><strong>0.039</strong></td><td><strong>0.027</strong></td><td><strong>0.050</strong></td><td><strong>-0.280</strong></td><td><strong>0.031</strong></td><td><strong>0.055</strong></td><td><strong>-0.369</strong></td><td><strong>0.007</strong></td></tr><tr><td>WHO-5 Well-Being Index</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Total</td><td><strong>0.155</strong></td><td><strong>0.151</strong></td><td><strong>0.146</strong></td><td><strong>0.204</strong></td><td><strong>0.191</strong></td><td><strong>0.223</strong></td><td><strong>0.092</strong></td><td><strong>0.231</strong></td></tr><tr><td>CES-D Scale</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Total</td><td><strong>-0.004</strong></td><td><strong>0.001</strong></td><td><strong>-0.011</strong></td><td><strong>-0.235</strong></td><td><strong>-0.035</strong></td><td><strong>-0.052</strong></td><td><strong>-0.251</strong></td><td><strong>-0.071</strong></td></tr><tr><td>Diabetes duration</td><td><strong>0.014</strong></td><td><strong>0.035</strong></td><td><strong>-0.014</strong></td><td><strong>0.122</strong></td><td><strong>0.001</strong></td><td><strong>-0.036</strong></td><td><strong>-0.160</strong></td><td><strong>0.120</strong></td></tr></tbody></table>

CES-D, Centre for Epidemiological Studies Depression; HCP, health-care provider; ICC, intraclass correlation coefficient; IGMSS, Impact of Glucose Monitoring on Self-Management Scale; WHO, World Health Organization.

Note: Bolded statistics indicate significant correlations.

* p<0.01.

† p<0.001.

correlations were in the r=0.4 to 0.7 range: r=0.378 for Capability, r=0.586 for Opportunity, and r=0.472 for Motivation. The GMSS openness and worthwhileness scales correlated well with all IGMSSs. Interestingly, there were strong negative correlations between the positive experience of device characteristics and the emotional and behavioural burden scales on the GMSS.

Convergent validity was investigated by correlating the IGMSS with the behavioural and emotional scales (Table 5). Correlations between IGMSS and DSMQ results show that Capability was predictive of all aspects of self-management, except use of health care. This relationship held for personalized knowledge and improved health scales. Furthermore, a higher Opportunity score predicted all aspects of self-management. Improved HCP and Social Relationships did not correlate with use of health care, whereas Device Characteristics did predict use of health care. Finally, greater motivation was significantly associated with all aspects of self-management except use of health care.

Participants also completed the DDS, the CES-D, and the WHO-5 (Table 5) to allow IGMSS outcomes to be related to diabetes-related distress, depression, and QOL. Neither Capability nor Motivation items were related to diabetes distress, but Opportunity was associated with diabetes distress, primarily through the negative aspects of the sensing device. Those individuals with more negative experiences had higher levels of distress.

We also examined the relationships between the general mood measures (WHO-5 and CES-D scales) and the IGMSS. Higher scores on Capability, Opportunity, and Motivation (along with their subscales) all predicted increased QOL scores on the WHO-5. None of the Capability subscales or Motivation were associated with depression. Regarding Opportunity, those who experienced more negatives with the sensing device reported higher depression scores.

Finally, to evaluate discriminative validity we correlated IGMSS with duration of T2D. As predicted correlations were very low and the only subscale on which a relationship was found was Device Characteristics, where those individuals with longer duration diabetes reported fewer positive experiences with devices.

<table><caption>**Table 6**
Percentages of participants who agree or disagree with positive impact of CGM devices (N=514)</caption><thead><tr><th></th><th>Disagree*</th><th>Agree*</th></tr></thead><tbody><tr><td>Capability</td><td>1.9%</td><td>79.0%</td></tr><tr><td>Personalized Knowledge</td><td>2.3%</td><td>78.6%</td></tr><tr><td>Improved Health</td><td>2.7%</td><td>79.0%</td></tr><tr><td>Motivation</td><td></td><td></td></tr><tr><td>Improved Self-management</td><td>4.1%</td><td>75.3%</td></tr><tr><td>Opportunity</td><td>2.5%</td><td>46.5%</td></tr><tr><td>Improved HCP Relationships</td><td>6.2%</td><td>77.2%</td></tr><tr><td>Improved Social Relationships</td><td>9.3%</td><td>70.0%</td></tr><tr><td>Device Characteristics</td><td>17.3%</td><td>39.9%</td></tr><tr><td>It is comfortable to use</td><td>26.7%</td><td>43.0%</td></tr><tr><td>It provides me with reliable information</td><td>28.4%</td><td>33.3%</td></tr><tr><td>I feel comfortable sharing my glucose data with my HCPs</td><td>15.0%</td><td>60.9%</td></tr><tr><td>Although it can be visible, I feel comfortable with other people recognizing it and realizing I have diabetes</td><td>24.9%</td><td>48.2%</td></tr><tr><td>I don't mind that wearing it reminds me that I have diabetes</td><td>31.3%</td><td>41.4%</td></tr></tbody></table>

CGM, continuous glucose monitoring; HCP, health-care provider.

* Percentage of respondents who either agreed (mean score >3.5 on the 5-point Likert scale) or disagreed (mean score <2.5 on the 5-point Likert scale) with the Impact of Glucose Monitoring on Self-Management Scales.
## *Behavioural characteristics of sensing device users*

Table 6 presents the percentages of respondents who either agreed (mean score >3.5 on the 5-point Likert scale) or disagreed (mean score <2.5) with the IGMSSs. These data show that most CGM users experienced the device having improved their engagement in self-management. In terms of ability to self-manage, 79.0% of participants indicated increased Capability, with 78.6% reporting improved personalized knowledge of glucose management and 79.0% reporting improved health using the sensing device. Similar results were found for impact of the sensing device on Motivation, where 75.3% of the participants agreed that the device improved motivation for self-management. The results regarding Opportunity were not as strongly positive, with 46.5% of respondents agreeing that the CGM device improved their opportunity for self-management, primarily by improving their relationships with HCPs (77.2% agreement) and within social relationships (70.0% agreement). However, only 39.9% of respondents scored high on the Device Characteristics subscale, and 17.3% agreed that the negative aspects of the CGM device impaired self-management.

We further explored the results regarding Device Characteristics by using an item analysis of this subscale to identify whether there were specific predominant negative experiences (Table 6). Most participants (60.9%) agreed with the experience of being comfortable sharing data with their HCPs, with only 15% in disagreement. Nonetheless, between one-fourth and one-third of respondents indicated concerns over comfort, obtaining reliable information, and being reminded (by the device or by other people) of having diabetes.

## Discussion

Our study findings support the reliability and validity of the newly developed IGMSS, which assesses the impact of a person's glucose monitoring method on Capability, Opportunity, and Motivation to self-manage their diabetes. Specifically, Capability assesses how glucose monitoring may increase personalized knowledge of the link between behaviour and glucose management and by providing evidence of improved health by acting on that link (altering behaviour to alter glucose level). In addition, the IGMSS can assess how the method of glucose monitoring impacts self-management motivation. Finally, the method of glucose monitoring can impact the social opportunity to become engaged in self-management through improved relationships with HCPs, as well as in social contexts, in the context of the device characteristics.

The IGMSS performed well in terms of construct and convergent validity, correlating significantly with a validated measure of glucose-monitoring device satisfaction. Similarly, the IGMSS was able to predict self-reported self-management behaviour, and could identify relationships between a positive experience of CGM use and emotional well-being (as measured by reductions in diabetes distress and depression, as well as improved QOL). Discriminant validity was also confirmed in that all correlations between diabetes duration and device characteristics were low (<0.2). Furthermore, the IGMSS was stable over time (test–retest reliability), except for the Device Characteristics subscale. It appears that the experience of the device itself can fluctuate over time. In the subsample of participants who repeated the IGMSS after 3 months, their experience improved with regard to Device Characteristics (mean score increase from 2.64 to 3.28, p<0.001). This suggests that the experience of the Device Characteristics is modifiable, which may be reassuring to HCPs by suggesting that educational interventions can overcome concerns about CGM devices.

We believe that behaviour change components evaluated by the IGMSS may be useful for diabetes management in the context of understanding the capability, opportunity, and motivation for change with CGM devices [16]. The IGMSS provides a metric for each of these constructs. Furthermore, the IGMSS provides scores for Personalized Knowledge and Improved Health. The ability to measure the extent to which people with diabetes develop knowledge of the moment-to-moment relationship between behaviour and glycemic management is a key component of diabetes self-management. Providing a mechanism through which individuals can link their behaviour to their perceived health is likely to be beneficial in a disease that may otherwise be silent until complications develop.

A further key aspect of behaviour is the supportive opportunity to act and the IGMSS has identified some noteworthy constructs associated with this opportunity. If CGM empowers individuals with T2D to feel like more active partners with their HCPs, their diabetes self-management is likely to improve. In this context, because self-management can be impaired by the stressful and often stigmatizing experiences of living with diabetes in a public environment [17], CGM may better empower individuals to incorporate their T2D into their social situation. Although the constructs developed in the IGMSS appear to assess positive management characteristics, we also found that the device characteristics can be potentially troublesome. Concerns such as comfort and visibility may be challenging for some people with T2D.

Finally, but of no less importance, assessing the impact of CGM on motivation can be essential. The IGMSS assesses this motivational impact and our study of CGM users has shown that the large majority are motivated to manage their diabetes because of CGM. Considering the item, "To be more engaged (involved) in controlling my glucose levels," 96% of CGM users agreed with this statement. Similarly, for the item, "To want to take action to better manage my diabetes," 96.6% of CGM users agreed with this statement. We believe that the availability of the IGMSS patient reported outcome measurement of the impact of technology or diabetes self-management education on motivation for self-management is a significant contribution to diabetes care.

The applications of the IGMSS can be evaluated now that it has been developed and validated using classical test theory. This includes assessing the sensitivity of the scale to change when individuals switch from traditional SMBG to CGM, as well as the ability to show that changes in the IGMSS can predict glucometric improvements, especially glycated hemoglobin. In addition to being an outcome measure, the IGMSS can be used as a screening tool and be incorporated into diabetes self-management education as a dialogue tool to educate people with T2D as to the motivating impact of CGM on self-management.

Our study has both strengths and limitations. The study sample, although large enough to reliably conduct psychometric analyses, was recruited from a survey company panel. Such individuals may not be representative of the average Canadian living with diabetes and may not be representative of those seen in clinical practice. Also, all data were self-reported and we did not collect any clinical data. Follow-up research should evaluate in greater depth the relationship between IGMSSs and clinical characteristics, especially glucose management. Because only limited data were collected from participants, there is limited insight into how participants were receiving care and managing their diabetes. For instance, we did not specify use of GLP-1 receptor antagonists or sodium-glucose cotransporter-2 inhibitor treatments and how they may impact motivation for self-management. Finally, it will be important to examine the relationship of this scale with other measures of motivation. Although not specific to diabetes technologies, the Diabetes Empowerment Scale [15] may be a good instrument to include in future research using the IGMSS. Strengths of our study
were its high internal consistency and test–retest reliability. The substantial overlap between the IGMSS and established measures of CGM satisfaction was also a strength.

In conclusion, too few persons living with T2D are achieving clinical practice guidelines targets for glucose, cardiometabolic, and renal outcomes [4]. There is an urgent need for action given the recent prediction by the International Diabetes Federation [18] that rates of diabetes will increase by >50% by 2045. Although clinical inertia can be addressed through medical education and support, the person with diabetes must also be engaged and motivated in self-management behaviours for outcomes to be realized. In the context of the demonstrated positive impact of CGM on diabetes outcomes, we have been able to examine the ways in which CGM may motivate a person to become more engaged in self-management. Based on a qualitative study of persons with T2D who reported CGM to be a “game-changer,” we created the IGMSS, incorporating behaviour change theory and expert opinion. Our psychometric evaluation of this study resulted in a 22-item scale with positive reliability and validity. We believe that this scale can be used to evaluate, screen, and counsel people with T2D to take a more active role in their care.

## Supplementary Material

To access the supplementary material accompanying this article, visit the online version of the *Canadian Journal of Diabetes* at www.canadianjournalofdiabetes.com.

## Acknowledgments

The authors acknowledge funding support from Abbott Diabetes Care. The funding did not affect the collection, analysis, or presentation of the data.

## Author Disclosures

M.V. reports financial support from Abbott Diabetes Care as well as ad board/speaker support involvement with Abbott Diabetes Care, Novo Nordisk, Boehringer Ingelheim, and LifeScan. L.B. has been an advisor/consultant or on the speaker's bureau for Eli Lilly, Sanofi, Novo Nordisk, Abbott Diabetes Care, BD, MontMed, Bayer, Dexcom, AstraZeneca, Boehringer Ingelheim, Roche, and HLS Therapeutics. E.C. and F.K. have served as consultants for Abbott Diabetes Care. F.L.G. is employed by Abbott Diabetes Care. N.N. has received speaking fees from Medtronic and Grunenthal. R.R.L. has received research grants from AstraZeneca, Eli Lilly, Merck, Novo Nordisk, Sanofi-Aventis, and Vertex; has been a consultant or advisory panel member for Abbott, Amgen, AstraZeneca, Bayer, Carlina Technology, Dexcom, Eli Lilly, HSL Therapeutics, Insulet, Janssen, Medtronic, Merck, Novo Nordisk, Pfizer, and Sanofi-Aventis; and has received honoraria for conferences from Abbott, AstraZeneca, the CMS Canadian Medical & Surgical Knowledge Translation Research Group, the CPD Network, Dexcom, Eli Lilly, Janssen, Medtronic, Merck, Novo Nordisk, Sanofi-Aventis, and Vertex. R.R.L. also reports having received unrestricted grants for clinical and educational activities from Abbott, Eli Lilly, Medtronic, Merck, Novo Nordisk, and Sanofi-Aventis, and holds intellectual property in the field of type 2 diabetes risk biomarkers, catheter life, and the closed-loop system. W.P. has served as a consultant for Dexcom and Abbott Diabetes Care.

## Author Contributions

M.V. is the guarantor of this work and, as such, had full access to all study data and takes responsibility for the integrity of the data and accuracy of the data analysis. All authors contributed to the methodology, analysis, and writing of the manuscript. All authors have met the International Committee of Medical Journal Editors criteria for authorship, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

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**Supplemental Table 1**

Factor analysis of Capability, Opportunity and Motivation items

<table><thead><tr><th colspan="4">Capability items (1 factor – 59.1% of variance)</th></tr><tr><th colspan="2">Using my Glucose Sensing Device has helped me to:</th><th>Factor Loadings<sup>*</sup></th></tr></thead><tbody><tr><td colspan="2">Understand how specific foods (type, amount, preparation, etc.) directly affect my glucose levels</td><td><strong>0.786</strong></td></tr><tr><td colspan="2">Understand how exercise (type, duration, intensity) directly affects my glucose levels</td><td><strong>0.747</strong></td></tr><tr><td colspan="2">Understand how stress (intensity, duration) directly affects my glucose levels</td><td><strong>0.710</strong></td></tr><tr><td colspan="2">Learn how I can adjust my behaviour to keep glucose readings within range</td><td><strong>0.829</strong></td></tr><tr><td colspan="2">Know if my glucose level is trending up or down at any moment</td><td><strong>0.786</strong></td></tr><tr><td colspan="2">See the larger picture of how my own efforts can keep my diabetes under better control</td><td><strong>0.844</strong></td></tr><tr><td colspan="2">Avoid highs and lows by using the trend values or using the alarms</td><td><strong>0.750</strong></td></tr><tr><td colspan="2">Improve my A1c level (the blood test that measures 3-month control)</td><td><strong>0.773</strong></td></tr><tr><td colspan="2">Improve my general health</td><td><strong>0.810</strong></td></tr><tr><td colspan="2">To stay safe from problems with low blood sugars</td><td><strong>0.743</strong></td></tr><tr><td colspan="2">Using the sensing device has become automatic for me</td><td><strong>0.707</strong></td></tr><tr><th colspan="4">Opportunity items (3 factors)</th></tr><tr><th colspan="2">Using my Glucose Sensing Device has helped me to:</th><th>Factor 1 loadings (27.63% variance)</th><th>Factor 2 loadings (25.59% variance)</th><th>Factor 3 loadings (6.05% variance)</th></tr><tr><td colspan="2">Have more useful conversations with my healthcare provider(s) about diabetes management</td><td>0.016</td><td><strong>0.760</strong></td><td>0.182</td></tr><tr><td colspan="2">Have a better relationship with my healthcare provider(s)</td><td>0.031</td><td><strong>0.851</strong></td><td>0.028</td></tr><tr><td colspan="2">Receive better care from my healthcare provider(s)</td><td>0.016</td><td><strong>0.835</strong></td><td>0.112</td></tr><tr><td colspan="2">Receive more efficient care since diabetes visits don't take so long</td><td>-0.019</td><td><strong>0.785</strong></td><td>0.198</td></tr><tr><td colspan="2">Improve the conversation about diabetes with the other people in my life</td><td>-0.024</td><td><strong>0.765</strong></td><td>0.217</td></tr><tr><td colspan="2">Feel more cared for because others can view and respond to my glucose levels if I need help</td><td>-0.026</td><td><strong>0.760</strong></td><td>0.196</td></tr><tr><td colspan="2">To have positive conversations about diabetes with others when they ask questions</td><td>-0.005</td><td><strong>0.727</strong></td><td>0.222</td></tr><tr><td colspan="5">Using my Glucose Sensing Device is problematic because:</td></tr><tr><td colspan="2">My health insurance will not cover all the costs</td><td><strong>0.595</strong></td><td>-0.005</td><td>0.056</td></tr><tr><td colspan="2">It is uncomfortable to wear (e.g., falls off, bothers my skin, interferes with clothing, more visible than I like etc)</td><td><strong>0.794</strong></td><td>0.042</td><td>0.012</td></tr><tr><td colspan="2">It is more visible than I want it to be</td><td><strong>0.787</strong></td><td>-0.025</td><td>0.058</td></tr><tr><td colspan="2">It is not always as accurate as it should be.</td><td><strong>0.637</strong></td><td>-0.025</td><td>0.058</td></tr><tr><td colspan="2">I don't feel comfortable sharing all my data with my healthcare providers</td><td><strong>0.734</strong></td><td>0.236</td><td>-0.213</td></tr><tr><td colspan="2">My healthcare providers are not really using the data from my device</td><td><strong>0.692</strong></td><td>0.026</td><td>0.058</td></tr><tr><td colspan="2">It keeps falling off</td><td><strong>0.710</strong></td><td>0.154</td><td>-0.069</td></tr><tr><td colspan="2">Because it is visible, I don't feel comfortable with other people knowing I have diabetes</td><td><strong>0.770</strong></td><td>0.083</td><td>-0.057</td></tr><tr><td colspan="2">It reminds me that I have diabetes</td><td><strong>0.700</strong></td><td>-0.120</td><td>0.169</td></tr><tr><td colspan="2">I am having to think about my diabetes more than I want to</td><td><strong>0.732</strong></td><td>-0.181</td><td>0.046</td></tr><tr><td colspan="5">Regarding using a Glucose Sensing Device:</td></tr><tr><td colspan="2">I have support from my family to use the sensing device for managing my diabetes</td><td>0.024</td><td>0.332</td><td><strong>0.802</strong></td></tr><tr><td colspan="2">People whose opinion I value support me to use the sensing device for managing my diabetes</td><td>0.014</td><td>0.404</td><td><strong>0.769</strong></td></tr><tr><td colspan="2">I have all the resources I need (money, time) to continue using the sensing device</td><td>0.125</td><td>0.308</td><td><strong>0.534</strong></td></tr><tr><th colspan="5">Motivation items (2 factors)</th></tr><tr><th colspan="2">Using my Glucose Sensing Device has helped me to:</th><th>Factor 1 loadings (57.48% variance)</th><th>Factor 2 loadings (11.36% variance)</th></tr><tr><td colspan="2">To be more engaged (involved) in controlling my glucose levels</td><td>0.273</td><td><strong>0.848</strong></td></tr><tr><td colspan="2">Take control of my diabetes</td><td>0.228</td><td><strong>0.811</strong></td></tr><tr><td colspan="2"><strong>To want to take action to better manage my diabetes</strong></td><td>0.296</td><td><strong>0.835</strong></td></tr><tr><td colspan="5">Because of using my Glucose Sensing Device I am:</td></tr><tr><td colspan="2">More confident in managing hypoglycemia</td><td><strong>0.785</strong></td><td>0.349</td></tr><tr><td colspan="2">More optimistic about my diabetes</td><td><strong>0.862</strong></td><td>0.214</td></tr><tr><td colspan="2">Finding that life with diabetes is easier</td><td><strong>0.796</strong></td><td>0.156</td></tr><tr><td colspan="2">More confident that I can manage diabetes</td><td><strong>0.798</strong></td><td>0.373</td></tr><tr><td colspan="2">More confident in my everyday life</td><td><strong>0.813</strong></td><td>0.274</td></tr><tr><td colspan="2">More hopeful about the future</td><td><strong>0.847</strong></td><td>0.229</td></tr><tr><td colspan="5">Regarding using a Glucose Sensing Device:</td></tr><tr><td colspan="2">I intend to continue to use a sensing device to manage my diabetes</td><td><strong>0.568</strong></td><td>0.384</td></tr><tr><td colspan="2">I believe that if I stopped using a sensing device my diabetes control would be worse</td><td><strong>0.533</strong></td><td>0.253</td></tr></tbody></table>

<footnote>* Factor loading show the extent to which an item contributes to that Factor. Loadings above 0.5 are considered to be items associated with that Factor. Bolded numbers load on that Factor.</footnote>