Abstract
Aim:
This study aimed to capture the experience of parents of youth with recent onset Type 1 diabetes who initiated use of continuous glucose monitoring (CGM) technology soon after diagnosis, which is a new practice.
Methods:
Focus groups and individual interviews were conducted with parents of youth with Type 1 diabetes who had early initiation of CGM as part of a new clinical protocol. Interviewers used a semi-structured interview guide to elicit feedback and experiences with starting CGM within 30 days of diagnosis, and the benefits and barriers they experienced when adjusting to this technology. Groups and interviews were audio recorded, transcribed and analysed using content analysis.
Results:
Participants were 16 parents (age 44.13 ± 8.43 years; 75% female; 56.25% non-Hispanic White) of youth (age 12.38 ± 4.15 years; 50% female; 50% non-Hispanic White; diabetes duration 10.35 ± 3.89 months) who initiated CGM 11.31 ± 7.33 days after diabetes diagnosis. Overall, parents reported high levels of satisfaction with starting CGM within a month of diagnosis and described a high level of reliance on the technology to help manage their child’s diabetes. All participants recommended early CGM initiation for future families and were committed to continue using the technology for the foreseeable future, provided that insurance covered it.
Conclusion:
Parents experienced CGM initiation shortly after their child’s Type 1 diabetes diagnosis as a highly beneficial and essential part of adjusting to living with diabetes.
Keywords: children and adolescents, devices, health care delivery, psychological aspects
1 |. INTRODUCTION
Continuous glucose monitoring (CGM) systems compared with self-monitoring of blood glucose have resulted in greater improvements in glycaemic outcomes and quality of life in youth with Type 1 diabetes using continuous subcutaneous insulin infusion or multiple daily injection therapy.1,2 One caveat is that the benefits of CGM correlate with the frequency of and access to ongoing device use.3,4 Early introduction to CGM in conjunction with health care provider/care team education and insulin-dosing adjustments can allow for tighter glucose level ranges during the clinical remission phase.5 It has also been shown that CGM initiation in the new onset period is in fact feasible and well accepted by youth and their families.6 As such, the American Diabetes Association ‘Standards of Medical Care in Diabetes’ recommend that CGM should be considered in all children and adolescents with Type 1 diabetes.7
Based on the Type 1 Diabetes Exchange and Diabetes Prospective Follow-up (Diabetes-Patienten-Verlaufsdokumentation) registries, CGM use in individuals <18 years of age has increased from <5% in 2011 to ~31% and 44% in 2017, respectively.8 In a study conducted on parents’ perspectives of using remote monitoring and CGM in children with Type 1 diabetes for >1 year, parents reported improved sleep quality, increased peace of mind, impact on anxiety and greater freedom and confidence.9
Preliminary quantitative data have demonstrated sustained usage and benefits of early CGM initiation for glycaemic outcomes.6 However, little is known qualitatively about how parents and their children experience the process of CGM initiation during this new onset period. A new diagnosis of Type 1 diabetes is a major life adjustment, and families already receive a large amount of necessary education on diabetes management.10–12 Diabetes distress is common for parents during this new onset period,13 so it is not known how CGM introduction during this period affects parents who are also adjusting to and learning daily management of Type 1 diabetes. Therefore, the purpose of this qualitative study was to explore experiences of device initiation among families who received their CGM within approximately 1 month of Type 1 diabetes diagnosis to inform and improve upon future clinical practice.
2 |. RESEARCH DESIGN AND METHODS
This study was part of a pragmatic research study, for which the full approach has been previously reported.5 The larger study established a new clinical protocol to initiate CGM within 30 days of Type 1 diabetes diagnosis. Families received 30 days of CGM supplies at no cost through the research study; insurance approval was applied for during this time. All families received Dexcom G6 CGM (Dexcom Inc.), which was selected for the study for several reasons: factory calibration, integration with Apple Health and Food and Drug Administration approval for a paediatric age group. Figure 1 presents an overview of the flow of care delivery following diagnosis. CGM was initiated at Visit 2 following diagnosis, which was an outpatient visit.
FIGURE 1.
Flow of care delivery for early continuous glucose monitoring (CGM) initiation. T1D, Type 1 diabetes
2.1 |. Sample and recruitment
Eligible participants were those who were part of the larger study: parents of youth who had started CGM within 1 month of their Type 1 diabetes diagnosis and had a minimum diabetes duration of 6 months. We approached a convenience sample of participants from the larger study to share their experiences with CGM initiation after diagnosis. This study was approved by the Stanford University Institutional Review Board. Participants were compensated with a $50 gift card.
2.2 |. Data collection
Focus groups and interviews were held between February and May 2020 over a HIPAA-compliant videoconference platform (Zoom), which enabled continuing recruitment and participation during the SARS-CoV-2 pandemic. Efforts were made to recruit at least two to three parents per group; individual interviews were conducted if last-minute cancellations led to only one parent in attendance. Focus groups and interviews explored parents’ experiences and perceptions about (1) initiating CGM shortly following their child’s Type 1 diabetes diagnosis; (2) the perceived benefits and burdens of using CGM; and (3) their intentions to continue using CGM in the future. Groups and interviews were conducted by two researchers (M.L.T. and D.P.Z.) using a semi-structured interview guide to ensure consistency across groups and interviewers. The interview guide was developed with input from the clinical and research team who implemented the protocol for the larger trial. Primary questions from the interview guide are presented in Table 1. Groups and interviews were recorded and transcribed. A total of five groups (with between two and four participants) and three individual interviews were conducted. Interviews and groups lasted between 39 and 94 min. Transcriptions were checked for quality and de-identified prior to use for qualitative data analysis.
TABLE 1.
Primary interview/focus group questions
How soon after diagnosis do you think is the best time to start CGM? |
What has your experience been with using CGM and starting it soon after your child’s diagnosis? |
Have you experienced any technical challenges with using CGM? |
Do you think CGM has helped with your overall stress about diabetes? |
Do you think you will continue to use CGM going forward? Why or why not? |
Abbreviation: CGM, continuous glucose monitoring.
2.3 |. Data analysis
Data from transcripts were analysed using the Framework Method,14,15 combined with thematic analysis.16 During an initial open coding phase, all three coders independently read and coded one transcript to develop a working analytical framework. The initial framework was then applied to subsequent transcripts. Coders developed and refined the framework through an iterative process that was both top-down (informed by initial focus group questions) and bottom-up (adding new codes as needed, arising from the data). The analytical framework was revised until no new codes emerged. Throughout this process, coders met weekly to discuss codes and iteratively revise the analytical framework. Transcripts coded in the initial phase were then re-coded to apply the final framework. Three coders (A.A., M.L.T. and D.P.Z.) trained in qualitative data analysis participated in coding and analysis. The coding team was multidisciplinary (a paediatric endocrinologist, a clinical health psychologist with diabetes expertise and an exercise physiologist and diabetes researcher who lives with Type 1 diabetes and uses CGM), enabling investigator triangulation and supporting credibility of the data.17 Each transcript was coded by two coders. Initial per cent agreement between the two coders was 79.7%. Through group discussion and a third coder reviewing and resolving discrepancies, agreement was reached on all codes. Finalized coding was entered into NVivo 12 qualitative data analysis software.18 Once all transcripts were coded, data were charted into matrices containing codes and illustrative quotes.14,19 One matrix was created for each transcript, and then these were synthesized to create a matrix representing all transcripts. To additionally support credibility, the overall framework and results were presented to the larger clinical team (endocrinologists, nurse practitioners and diabetes educators) involved in implementing the CGM initiation protocol for feedback. To support dependability and confirmability, the coding team maintained an audit trail throughout coding to track decision making.20 The Standards for Reporting Qualitative Research was used to ensure rigour.21
3 |. RESULTS
3.1 |. Participants
Our sample consisted of 16 parents (parent age 44.13 ± 8.43 years old, 75% female, 56.25% non-Hispanic White; child age 12.38 ± 4.15 years old, 50% female, 50% non-Hispanic White; diabetes duration 10.35 ± 3.89 months at time of participation). Table 2 presents participant characteristics.
TABLE 2.
Participant characteristics (N = 16)
N (%) | M (SD) | Range | |
---|---|---|---|
Parent age (years) | 44.13 (8.43) | 30–55 | |
Parent gender | |||
Female | 12 (75) | ||
Male | 4 (25) | ||
Parent race/ethnicity | |||
White | 9 (56.25) | ||
Asian | 2 (12.5) | ||
Hispanic | 1 (6.25) | ||
Not available | 4 (25) | ||
Youth age (years) | 12.38 (4.15) | 3–19 | |
Child gender | |||
Female | 8 (50) | ||
Male | 8 (50) | ||
Child race/ethnicity | |||
White | 8 (50) | ||
Asian | 3 (18.75) | ||
Hispanic | 3 (18.75) | ||
Other | 1 (6.25) | ||
Not available | 1 (6.25) | ||
Insurance type | |||
Private | 14 (77.78) | ||
Public | 4 (22.22) | ||
Months since diagnosis | 10.35 (3.89) | 5–18 | |
CGM start (days after diagnosis) | 11.31 (7.33) | 4–30 |
Abbreviation: CGM, continuous glucose monitoring.
3.2 |. Themes
3.2.1 |. Feedback on timing of CGM start in relation to diagnosis
Participants reported appreciating starting CGM within the first month after their child’s diagnosis (Table 3). Parents expressed differing preferences in exactly how soon within the first month after diagnosis ranging from a few days to a few weeks post-diagnosis. Most parents shared that they felt it was important to become comfortable with finger sticks to check blood glucose levels prior to starting CGM, and some felt this could be done in several days whereas others felt 1–2 weeks would be sufficient. Further, whereas some parents expressed wanting some initial time to adjust to the diagnosis before initiating CGM, others felt that CGM helped with this adjustment process.
TABLE 3.
Theme: Feedback on the timing of CGM initiation
Subtheme | Example quote |
---|---|
The sooner the better |
|
Start CGM after learning to do finger sticks |
|
Start CGM after an initial period of adjusting to the Type 1 diabetes diagnosis |
|
Abbreviation: CGM, continuous glucose monitoring.
3.2.2 |. Benefits of CGM experienced soon after Type 1 diabetes diagnosis
Most participants described multiple benefits to starting CGM including decreased stress; ability to use the data to improve diabetes management; fewer finger sticks for their child; better sleep for parents (because it reduced/eliminated the need to wake up in the middle of the night to do a finger stick); and the ability to access the data remotely when not with their child (which had positive implications for the child’s independence, for being at school or with other caregivers, for two-household families and for working parents; Table 4). The majority of parents reported that CGM initiation decreased stress, worry and anxiety in the early phase of adjusting to their child’s diagnosis and beyond. Parents pointed to data availability providing ‘peace of mind’, particularly overnight, because they knew they would be alerted if needed to help prevent hypoglycaemia. In addition, because CGM technology allows parents to remotely monitor their child’s glucose levels from their own smartphone, this feature helped reduced parents’ stress and worry when they were not with their child. Parents of teenagers in particular shared the benefit of not having to nag or disturb their adolescent to learn their glucose level.
TABLE 4.
Theme: Benefits of CGM experienced soon after Type 1 diabetes diagnosis
Subtheme | Example quote |
---|---|
Decreased stress |
|
Seeing the numbers on CGM enhances understanding of Type 1 diabetes and improves diabetes management |
|
Fewer finger sticks |
|
Increased independence and ability to be away from child but still monitoring diabetes |
|
Sleep benefit for parents |
|
Abbreviation: CGM, continuous glucose monitoring.
Access to CGM data also provided participants with an enhanced understanding of their child’s Type 1 diabetes and an improved ability to manage diabetes. Participants described using CGM data to learn about aspects of diabetes management including timing insulin doses; effects of different foods on glycaemia; and how quickly glucose values can change. Parents appreciated being able to start CGM within a month of diagnosis because it dramatically limited the number of finger sticks their child needed to do. Participants described finger sticks as painful for their children, inconvenient and as providing significantly less glucose data. Due to all of these benefits, several parents noted feeling grateful that their child was diagnosed at a time with this level of advanced technology available to them.
3.2.3 |. Burdens and hassles of CGM and associated stress
Most parents described burdens and hassles of CGM use, including accuracy issues, bleeding with insertion of CGM and other technical challenges and shortcomings of the device (e.g., signal loss, compression lows and adhesives not lasting). These challenges are consistent with those previously reported.22,23 Parents for the most part shared that the benefits they gained from the technology outweighed these hassles. Some participants noted that when they did not have access to data (e.g., due to signal loss or during the sensor warm-up period), they experienced a high level of stress and worry (Table 5).
TABLE 5.
Theme: Burdens and hassles with early CGM initiation
Subtheme | Example quote |
---|---|
Accuracy issues |
|
Bleeding with insertion of CGM |
|
Signal loss and other technical shortcomings (e.g., compression lows and adhesive issues) |
|
High stress when there is no access to data |
|
Abbreviation: CGM, continuous glucose monitoring.
3.2.4 |. Plans to continue using CGM in the future (if covered by insurance)
All parents confidently expressed that they intended for their child to continue to use CGM going forward. Parents described the technology as ‘life-changing’, ‘a basic necessity’, ‘game-changer’ and a ‘no-brainer’ to continue using in the future (Table 6). Several shared their disbelief that anyone could manage Type 1 diabetes without CGM technology. Parents also thought ahead to future benefits of CGM for their children including being able to use the device in college and also the ability to use CGM as part of a closed-loop system. The only potential barrier to sustained use of CGM reported by some parents is if their insurance plan changes and does not cover CGM in the future.
TABLE 6.
Theme: Future plans to use CGM
Subtheme | Example quotes |
---|---|
CGM as a necessity |
|
Definitely will continue to use (if insurance covers it) |
|
Abbreviation: CGM, continuous glucose monitoring.
4 |. DISCUSSION
This study presents qualitative data on the experience of parents of youth who initiated CGM soon after their Type 1 diabetes diagnosis, a new practice that has been shown quantitatively to improve glycated haemoglobin (HbA1c) and lead to sustained CGM use.6 Our findings demonstrate that parents not only accepted CGM soon after their child’s diagnosis but also viewed this technology as essential to adjusting to the diagnosis and overall diabetes management. Although parental preference on the exact timing of CGM initiation varied from a few days to a few weeks, all participants in the current study shared the view that they would not have wanted to wait longer to include CGM in the diabetes management regimen. Thus, despite the additional clinic visits and an increased time burden of CGM education24 in the first weeks after diabetes diagnosis to introduce CGM, all participants in the current study expressed the introduction of CGM during this time period was valuable and essential.
Parents in the current study cited a multitude of benefits they and their children experienced from CGM initiation post-diagnosis. Beyond the more obvious benefit of decreasing the need for finger sticks multiple times a day, parents described how the prompt introduction of CGM helped enhance their understanding of Type 1 diabetes in a way that improved overall diabetes management. Having access to up to 288 glucose data points a day led to parents learning more quickly about the effects of different foods and about the timing of insulin dosing. At the same time, parents described CGM as reducing their stress while adjusting to their child’s diagnosis and being able to sleep better at night knowing they had access to the data and would receive alerts to be able to prevent and respond to potential hypoglycaemia. Finally, many parents shared ways in which CGM enabled them to be apart from their child when at work and school while remaining actively engaged with their child’s diabetes care.
At the same time, parents shared an acceptance and awareness of the fact that CGM technology is not perfect. They shared a variety of experiences with shortcomings of the technology, some of which were hurdles they were able to troubleshoot and learn from (e.g., compression lows), whereas others remained longer term frustrations and disappointments with the technology (e.g., signal loss, warm-up period without data, Bluetooth connection issues and accuracy) that they wished could be improved upon.
Still, parents expressed that the benefits of CGM use outweighed the shortcomings. When asked if they planned for their child or adolescent to continue using CGM in the future, all participants firmly stated that they would. The only caveat mentioned by some parents was insurance coverage determining their ability to continue using CGM. This finding is consistent with prior research demonstrating that insurance coverage, or lack thereof, determines whether individuals and families are able to sustain CGM use.4,25–27 In the United States, individuals from lower socio-economic groups use CGM at significantly lower rates than those from higher socio-economic groups; this relationship between socio-economic status and CGM use is not seen in Germany where insurance and health care delivery differ from the United States.28 Many in the current study described the technology as a ‘necessity’ for their child’s diabetes care that they would not want to give up. Some also expressed an additional rationale for continuing to use the device that CGM is an essential piece of closed-loop systems to further improve and optimize their child’s diabetes management in the future.
There are several limitations to the current study. First, this study focused on the experiences of parents of youth with Type 1 diabetes instead of the youth themselves. Future research should explore the experiences of beginning to wear and use CGM shortly after diagnosis for this paediatric population and explore their perceptions of benefits and burdens of the technology.22 Adolescents commonly experience hassles and burdens associated with wearing CGM on their body,23 and parents’ experience of these burdens in relation to benefits may differ from the attitudes of their children. An additional limitation is that the relatively small sample size may limit generalizability to other families initiating CGM following their child’s diagnosis. This limitation is offset by the clear consensus and saturation on the study’s primary themes (i.e., perceived benefit of CGM for diabetes management, acceptance of early CGM initiation and plans to continue using the device). Focus groups and interviews were conducted in English, and the majority (78%) had private insurance, so findings may not be generalizable to non-English-speaking families and those with public insurance; more research is needed to explore the experience of early CGM initiation among a non-English-speaking clinic sample and families with public insurance. Relatedly, we did not collect additional data on socio-economic status of participants (e.g., household income and parental education); future studies should gather this information as well. Further, participants in the current study had already agreed to be part of the original study and start to use CGM. Some families declined use of CGM when offered, and more research is needed to understand the reasons for declining and whether families who declined differ by demographic, socio-economic, psychosocial or other characteristics.
This study’s findings generate hypotheses for a future quantitative study with a larger sample size to confirm the acceptance and satisfaction of CGM during the new onset Type 1 diabetes period. Given that families reported individual preferences in terms of CGM timing (from several days to several weeks after diagnosis), one important future direction is to explore strategies for tailoring the exact timing of CGM initiation to each family based on their readiness, which would be consistent with a precision medicine approach.29 Given some parents’ preference for initiating CGM days after diagnosis, CGM should likely be made available and offered to all families after diagnosis but then initiated once the family is ready. An additional hypothesis that may be worth further quantitative investigation is whether early CGM introduction decreases parental distress, given that participants in the current study shared ways that CGM alleviated anxiety and worry.
To conclude, this study’s qualitative data demonstrate that the new practice of introducing CGM within the new onset period of Type 1 diabetes is not only accepted but also viewed as essential by parents. Rather than add undue burden and distress during a significant life adjustment, CGM initiation appears to have contributed to reduced diabetes management burden and reduced distress and worry among parents in our study. These results complement prior quantitative findings that early introduction of CGM improved glucose time-in-range and that the majority of families used the technology consistently.6
This new approach to the new onset period represents a significant shift from emphasizing the value of this technology only for those with higher HbA1cs30,31 to recommending CGM to everyone as an important component of their diabetes care. Furthermore, use of CGM with the ability to transfer data to clinics can contribute to improvements in delivery of telehealth-based diabetes care, which has increased significantly during the SARS-CoV-2 pandemic and will likely be a continuing future trend in Type 1 diabetes care.32,33 That CGM was well accepted by families at this stage may also lead them to a greater likelihood of adopting advanced closed-loop technologies in the future; longitudinal research is needed to investigate the influence of early device initiation on likelihood to adopt new diabetes technologies later on.
What’s new?
Continuous glucose monitoring (CGM) in a paediatric Type 1 diabetes population has benefits for time spent in glucose target range and parents’ sleep and stress levels; introducing CGM shortly after Type 1 diabetes diagnosis is a new clinical practice.
Parents in this qualitative study reported a high level of acceptance of early CGM initiation following their child’s diagnosis, a sense of CGM as a ‘necessity’ and a clear intention to continue using CGM in the future.
Counter to clinical concerns that introducing a new device soon after Type 1 diabetes diagnosis could overwhelm families, these results point to the benefits of this new clinical practice for parents who described a range benefits to having access to the technology such as increased peace of mind overnight, an ability to learn about the impact of food and insulin on glucose levels and an appreciation for being able to monitor their child’s glucose levels remotely.
ACKNOWLEDGEMENTS
The authors would like to acknowledge all of the parents involved in the focus groups for their valuable input and insights regarding the new onset CGM process.
Funding information
Funding was provided in part by the Stanford Diabetes Research Center (P30DK116074) and R18DK122422. CGM supplies for the first month (transmitter, three sensors and receiver per patient) were donated by Dexcom. Funding for iOS devices was provided by a grant through the Lucile Packard Children’s Hospital Auxiliaries Endowment. M.L.T. is supported by K23DK119470. A.A. is supported by the Maternal Child Health Research Institute at Stanford University and byK12DK122550. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health
CONFLICT OF INTEREST
M.L.T., A.A., J.N., P.P., B.L. and C.N. have no conflicts to disclose. D.P.Z. has received speaking honoraria from Medtronic Diabetes, Ascensia Diabetes and Insulet. D.P.Z. also has research support from the Helmsley Charitable Trust and ISPAD-JDRF Research Fellowship. D.M.M. has had research support from the NIH, JDRF, NSF and the Helmsley Charitable Trust, and his institution has had research support from Medtronic Diabetes, Dexcom, Insulet, Bigfoot Biomedical, Tandem and Roche. D.M.M. has also consulted for Abbott, the Helmsley Charitable Trust, Sanofi, Novo Nordisk, Eli Lilly, Medtronic and Insulet. K.K.H. has received consulting fees from Lifescan Diabetes Institute and MedIQ and an investigator-initiated grant from Dexcom, Inc.
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