Abstract
Aim:
Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioral intervention (CGM+FBI), CGM alone (Standard-CGM), or blood glucose monitoring for 26 weeks before receiving CGM+FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks.
Methods:
CGM+FBI (n=45), Standard-CGM (n=42), and BGM-Crossover (n=44) participants completed psychosocial assessments at baseline, 26 weeks, and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups.
Results:
The BGM-Crossover group reported improved diabetes burden (Δ −6.9, 95% CI [−11.3, −2.6], p=0.003), fear of hypoglycemia (Δ −6.4, CI [−10.1, −2.6], p=0.002), and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p=0.005) from 26 to 52 weeks, similar to published findings in the CGM+FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6, 14.0], p=0.027) from baseline to 52 weeks. The CGM+FBI group reported less diabetes burden and fear of hypoglycemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate.
Conclusions:
Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioral support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short- and long-term.
Keywords: randomized clinical trial, young children, CGM, type 1 diabetes, burden, fear of hypoglycemia
Introduction
Managing type 1 diabetes during early childhood (i.e., age <8 years) is uniquely challenging due to young children’s significant physical, social, and emotional development during this time: rapid growth, variable insulin needs, unpredictable eating and physical activity, frequent illness, and developing communication skills [1]. Given that young children have limited ability to conduct necessary diabetes management tasks, parents or other adult caregivers are fully responsible for care. Managing this demanding regimen in young children can be burdensome and is associated with substantial parental emotional distress [2]. Common sources of distress among parents of young children with type 1 diabetes include fears about hypoglycemia [3–6], worries about long-term complications [5], difficulty managing children’s diabetes at bedtime and mealtimes [7–9], and concerns about children’s schooling and childcare [5, 10, 11]. Many parents report parenting stress [12, 13] and symptoms of anxiety and depression [3, 7].
Advanced diabetes technology use, including continuous glucose monitoring (CGM) devices, in young children has the potential to reduce parental burdens of diabetes management. Parents have reported benefits from CGM device functions (e.g., alerts for increasing/decreasing glucose levels, remote monitoring), including feeling less worried about their children’s glucose levels, more secure about their children’s safety, more comfortable with leaving their children with other caregivers, and having fewer sleep disruptions with CGM use [14, 15]. To enhance the glycemic and psychosocial benefits of CGM in young children and their parents, our research group conducted the Strategies to Enhance CGM use in Early childhood (SENCE) study [16, 17]. Data collection took place from 2016-2019. The SENCE study was a longitudinal, multi-site, randomized controlled trial comparing CGM with education alone (standard CGM), CGM with education and a family behavioral intervention for parents (CGM+FBI), and blood glucose monitoring alone without CGM or FBI (BGM) for 26 weeks [16]. Trial results at 26 weeks showed CGM use was associated with reduced time in hypoglycemia in both CGM groups, and the CGM+FBI group also demonstrated significant improvements in parent psychosocial outcomes (specifically, reduced diabetes burden and fear of hypoglycemia) compared to the standard CGM and BGM groups [17]. Following the 6-month SENCE trial, all groups participated in a 6-month extension phase. The BGM group received the CGM+FBI intervention protocol (referred to as the “BGM-Crossover” group) in weeks 26 to 52 to encourage participation and reduce attrition for those randomized to the BGM group. The original standard CGM and CGM+FBI groups were followed for the additional 26 weeks to observe intervention outcome maintenance. Effects on hypoglycemia reduction were sustained at 12 months [18]. A flowchart of study completion can be found in Supplemental Figure 1.
Here we report the 12-month psychosocial outcomes from the SENCE study’s CGM+FBI, standard CGM, and BGM-Crossover groups. The first aim of this analysis was to assess change in parents’ psychosocial outcomes in the BGM-Crossover group from 26-52 weeks (following initiation of CGM with education and FBI). We hypothesized the psychosocial outcomes in the BGM-Crossover group from 26-52 weeks would be comparable to the previously reported outcomes of the CGM+FBI groups observed from 0-26 weeks [17]. The second aim was to assess change in psychosocial outcomes in the standard CGM and CGM+FBI groups from 0 to 52 weeks. We hypothesized the previously reported improvements in diabetes burden, fear of hypoglycemia, and treatment satisfaction in the CGM+FBI group at 26 weeks [17] would be stable through week 52, demonstrating maintenance of improved psychosocial outcomes from 0 to 52 weeks in the CGM+FBI group.
METHODS
The SENCE study was performed at 14 U.S. diabetes centers, coordinated through the JAEB Center for Health Research. The study protocol was approved by the relevant institutional review boards and registered at ClinicalTrials.gov (NCT02912728). The research team at each site identified and recruited participants by reviewing electronic medical records, screening T1D Exchange Clinic Registry participant lists, posting advertisements, and/or by provider referral. Written informed consent was obtained from each parent and assent from appropriately-aged children prior to the start of any study procedures. Details of the study procedures can be found in the publications of the sample at baseline and primary glycemic outcomes following the intervention [16, 17].
Participants
To be eligible, youth were between the ages of 2 to <8 years old at the time of consent, living with type 1 diabetes for at least three months, and with an HbA1c between 7.0% and 10.0% (53-86 mmol/mol) at the time of enrollment. All were required to have not used real-time CGM in the 30 days prior to enrollment. Descriptions of participant recruitment and enrollment and characteristics of the study sample at baseline have been published [16–18]. A total of 143 children were randomized into the study, and 131 children remained in the study at 52 weeks.
Measures
Participants completed questionnaires via a secure, HIPAA-compliant web survey portal (REDCap) [19] at baseline, 26 weeks, and 52 weeks. All survey scores were converted to a 0-100 scale for ease of interpretation.
The Problem Areas in Diabetes – Parent Revised (PAID-PR) survey is an 18-item measure of parental burden associated with caring for their child with diabetes [20]. Item responses use a 5-point Likert scale (0=agree to 4=disagree), with higher scores indicating more perceived parental burden.
The Hypoglycemia Fear Survey for Parents of Young Children (HFS-PYC) is a 26-item measure of degree of parents’ fear of hypoglycemia [21]. Item responses use a 5-point Likert scale (1=never to 5=very often), with higher scores indicating greater fear. The HFS includes Behavior and Worry subscales. We report the Total score and individually report the Worry subscale score, as this 16-item subscale highlights specific clinically important parental concerns about their children’s low glucose levels.
The Diabetes Treatment Questionnaire (DTQ) is a 30-item measure of respondents’ perceptions of the current impact of diabetes devices and technologies and their satisfaction with the devices/technologies (DTQ Now), with parallel post-intervention version assessing perceptions of change in impact in impact and satisfaction (DTQ Change). Item responses use a 5-point Likert scale, with higher scores indicating more positive perceived impact and greater satisfaction with diabetes technologies [22].
The Diabetes Family Impact Scale (DFI-S) is a 15-item measure of negative impact of diabetes on various aspects of family functioning [23]. Item responses use a 4-point Likert scale (0=almost never to 3=almost always), with higher scores indicating greater negative impact.
The World Health Organization Well-Being Index (WHO-5) is a validated 5-item measure of perceived mental well-being. Item responses use a 6-point Likert scale (from 0=none of the time to 5=all of the time), with higher scores indicating greater perceived well-being [24].
The research team collected data from parents on child demographics (e.g., sex, race/ethnicity), diabetes duration, current diabetes treatment (e.g., insulin regimen, prior CGM use), and family socioeconomic information (e.g., parent education, household income, insurance type) at screening. Participants provided blood samples at 26 weeks, which were sent to a central laboratory for HbA1c measurement (University of Minnesota Tosoh A1c 2.2 Plus Glycohemoglobin Analyzer). Data can be found in Table 1.
Table 1.
Baseline Characteristics of Children with Data at 52 weeks
| Overall1 (N=131) |
CGM + FBI (N=45) |
Standard CGM (N=42) |
BGM Crossover (N=44) |
|
|---|---|---|---|---|
| Age (years) – Mean±SD | 5.7±1.8 | 5.7±1.6 | 5.1±1.8 | 6.1±1.7 |
| 2 to <4 | 27 (21%) | 7 (16%) | 13 (31%) | 7 (16%) |
| 4 to <6 | 41 (31%) | 17 (38%) | 15 (36%) | 9 (20%) |
| 6 to <8 | 63 (48%) | 21 (47%) | 14 (33%) | 28 (64%) |
| Diabetes Duration (years) – Mean±SD | 2.3±1.9 | 2.4±1.9 | 1.8±1.7 | 2.7±2.0 |
| <1 | 48 (37%) | 14 (31%) | 21 (50%) | 13 (30%) |
| 1 to <2 | 22 (17%) | 9 (20%) | 8 (19%) | 5 (11%) |
| 2 to <4 | 29 (22%) | 11 (24%) | 6 (14%) | 12 (27%) |
| ≥4 | 32 (24%) | 11(24%) | 7 (17%) | 14 (32%) |
| Insulin Pump Use – N (%) | 46 (35%) | 14 (31%) | 13 (31%) | 19 (43%) |
| Prior CGM Use – N (%) | ||||
| In past, but not current | 17 (13%) | 5 (11%) | 5 (12%) | 7 (16%) |
| Never | 114 (87%) | 40 (89%) | 37 (88%) | 37 (84%) |
| Sex: Female – N (%) | 65 (50%) | 26 (58%) | 17 (40%) | 22 (50%) |
| Race/Ethnicity – N (%) | ||||
| White, Non-Hispanic | 88 (69%) | 30 (68%) | 31 (76%) | 27 (63%) |
| Black, Non- Hispanic | 17 (13%) | 7 (16%) | 4 (10%) | 6 (14%) |
| Hispanic or Latino | 15 (12%) | 5 (11%) | 5 (12%) | 5 (12%) |
| Asian | 1 (<1%) | 0 (0%) | 0 (0%) | 1 (2%) |
| Another or More than One Race | 7 (5%) | 2 (5%) | 1 (2%) | 4 (9%) |
| Annual Household Income – N (%) | ||||
| <$35,000 | 21 (17%) | 6 (14%) | 10 (25%) | 5 (13%) |
| $35,000 to <$75,000 | 52 (43%) | 18 (43%) | 18 (45%) | 16 (41%) |
| ≥$75,000 | 48 (40%) | 18 (43%) | 12 (30%) | 18 (46%) |
| Highest Parent Education – N (%) | ||||
| High School or Less | 28 (23%) | 10 (24%) | 9 (24%) | 9 (20%) |
| Some College/AA | 42 (34%) | 11 (26%) | 14 (37%) | 17 (39%) |
| Bachelor’s or Higher | 54 (44%) | 21 (50%) | 15 (39%) | 18 (41%) |
| Health Insurance – N (%) | ||||
| Private | 80 (62%) | 27 (60%) | 26 (62%) | 27 (64%) |
| Other | 47 (36%) | 17 (38%) | 15 (36%) | 15 (36%) |
| None | 2 (2%) | 1 (2%) | 1 (2%) | 0 (0%) |
| HbA1c2 (%) [mmol/mol]– Mean ± SD | 8.2 ± 0.8 [66 ± 8] | 8.3 ± 0.8 [67 ± 9] | 8.2 ± 0.8 [66 ± 9] | 8.2 ± 0.7 [66 ± 8] |
| Total Daily Insulin Units per Kg – Mean±SD | 0.68 ± 0.22 | 0.68 ± 0.23 | 0.65 ± 0.23 | 0.69 ± 0.20 |
Missing data: race/ethnicity 3 (2%), income 10 (8%), parent education 7 (5%), health insurance 2 (2%), total daily insulin 1 (<1%).
Randomization HbA1c central lab value where available, otherwise the local screening value.
Intervention
Children in the CGM+FBI and the Standard CGM groups began use of the Dexcom G5 starting at week 1. A study team diabetes educator at each site provided CGM education for both groups via five standardized training sessions. CGM education sessions included training on CGM insertion and wear, setting glucose targets and alerts, troubleshooting high and low glucose levels, non-adjunctive dosing, and remote monitoring functions. Participants in the CGM+FBI group also participated in five behavioral intervention sessions delivered by trained non-medical study staff. The FBI provided education and support targeting common challenges parents of young children experience with diabetes technologies [25], including strategies to manage physical and emotional sensor insertion difficulties, emotional reactions to glucose fluctuations, and data and alert fatigue, as well as skills for problem-solving, seeking support, and explaining CGM to others [17]. FBI sessions took place in-person or by telephone, based on participant preferences at each site.
Participants in the BGM-Crossover group used standard blood glucose monitoring for the first 26 weeks, without CGM or CGM-related education or behavioral intervention. In the extension phase, the BGM-Crossover group completed surveys at week 26, began CGM wear, and received 5 CGM education sessions and 5 FBI sessions between weeks 26 to 52. During this phase, the CGM+FBI and Standard CGM groups continued to use CGM but did not receive any additional education or behavioral intervention. Participants in all groups completed a final data collection study visit at 52 weeks. Details of the study training schedule can be found in Supplemental Table 1.
Statistical Methods
The analysis cohort included all SENCE study participants from all 3 groups who completed the 52-week visit. For each questionnaire, a repeated measures linear regression model was fit including scores at baseline, 26 weeks, and 52 weeks for all three treatment groups. Separate treatment effects were modelled at 26 and 52 weeks by including a time by treatment interaction term. The treatment groups were forced to have the same mean value at baseline. The correlation between time points within individuals was modelled with an unstructured covariance matrix. The model adjusted for baseline HbA1c and clinical site (random effect). Point estimates and 95% confidence intervals for the change between baseline and 52 weeks, the change between 26 and 52 weeks, and the difference between the two CGM groups at 52 weeks were estimated from the model. Residuals diagnostics were performed to check model assumptions and sensitivity analyses were performed to assess the robustness of the results to the presence of confounding. P-values are two-sided and adjusted for multiple comparisons to control the false discovery rate using the Benjamini-Hochberg method adapted using the two-stage test [26]. Analyses were conducted with SAS software version 9.4 (SAS Institute Inc., Cary, NC).
RESULTS
Participants included 131 families of young children with type 1 diabetes who had data at 52 weeks: 42 children in the Standard CGM group, 45 children in the CGM+FBI group, and 44 children in the BGM-Crossover group. The subset of children in this analysis was demographically similar to the full sample of children originally randomized at baseline. At baseline, children were 5.7±1.8 years old with diabetes duration of 2.3±1.9 years, mean HbA1c 8.2 ± 0.8% [66 ± 8 mmol/mol], 35% of participants used an insulin pump, and 87% had never used CGM previously (the other 13% had not used CGM in the past 3 months). Table 1 provides details of participant demographic and family characteristics.
From 26 to 52 weeks, parents in the BGM-Crossover group reported decreased diabetes burden (PAID-PR change −6.9 [95% CI −11.3, −2.6], p=0.003), reduced fear of hypoglycemia (HFS total score change −6.4 [95% CI −10.1, −2.6], p=0.002; HFS worry score change −8.7 [95% CI −14.1, −3.2], p=0.002), and greater technology satisfaction (DTQ Now change 7.3 [95% CI 2.4, 12.2], p=0.005). Details can be found in Table 2. Figure 1 illustrates these data.
Table 2:
Psychosocial Outcomes in Parents whose Children Crossed Over from Blood Glucose Monitoring to CGM+FBI at 26 weeks
| N | Mean ± SD | Change from 26 to 52 Weeks (95% CI) [P-value] 1 |
|
|---|---|---|---|
| PAID-PR | |||
| Baseline | 43 | 49 ±17 | |
| 26 Weeks | 44 | 51 ±15 | |
| 52 Weeks | 43 | 43 ±16 | |
| Change from 26 to 52 Weeks | 43 | −7.0 ± 14.0 | −6.9 (−11.3, −2.6) [0.003] |
|
| |||
| HFS Total | |||
| Baseline | 42 | 41 ±16 | |
| 26 Weeks | 44 | 46 ±16 | |
| 52 Weeks | 42 | 39 ±15 | |
| Change from 26 to 52 Weeks | 42 | −6.4 ± 12.1 | −6.4 (−10.1, −2.6) [0.002] |
|
| |||
| HFS Worry | |||
| Baseline | 42 | 37 ±18 | |
| 26 Weeks | 44 | 43 ±20 | |
| 52 Weeks | 42 | 33 ±18 | |
| Change from 26 to 52 Weeks | 42 | −9.2 ± 17.8 | −8.7 (−14.2, −3.2) [0.002] |
|
| |||
| DTQ Now | |||
| Baseline | 43 | 52 ±17 | |
| 26 Weeks | 44 | 49 ±18 | |
| 52 Weeks | 43 | 56 ±16 | |
| Change from 26 to 52 Weeks | 43 | 7.5 ± 15.7 | 7.3 (2.4, 12.2) [0.005] |
|
| |||
| DTQ Change | |||
| 52 Weeks | 40 | 70 ±14 | |
|
| |||
| DFI-S | |||
| Baseline | 42 | 27 ±18 | |
| 26 Weeks | 43 | 28 ±19 | |
| 52 Weeks | 43 | 25 ±19 | |
| Change from 26 to 52 Weeks | 43 | −3.2 ± 15.7 | −2.8 (−7.6, 2.1) [0.25] |
|
| |||
| WHO-5 | |||
| Baseline | 43 | 65 ±20 | |
| 26 Weeks | 44 | 63 ±16 | |
| 52 Weeks | 42 | 66 ±20 | |
| Change from 26 to 52 Weeks | 42 | 2.9 ± 17.7 | 3.1 (−2.4, 8.6) [0.27] |
From a repeated measures linear regression model of baseline, 26 weeks, and 52 weeks adjusted for baseline HbA1c and clinical site as a random effect. P-values and confidence intervals are adjusted for multiple comparisons to control the false discovery rate (FDR).
Figure 1:
Psychosocial Outcomes by Treatment Group and Visit
From baseline to 52 weeks, parents in the CGM+FBI group also reported decreased diabetes burden (PAID-PR change −6.2 [95% CI −10.6, −1.7], p=0.010) and reduced fear of hypoglycemia (HFS total score change - −5.8 [95% CI −10.1, −1.5], p=0.010; HFS worry score change −7.7 [95% CI −13.5, −1.9], p=0.0010). There was a trend towards greater technology satisfaction (DTQ Now change 4.8 [95% CI −0.7, 10.3], p=0.08) Over this same period, parents in the standard-CGM group reported greater technology satisfaction (DTQ Nowchange 7.3 [95% CI 0.6, 14.0], p=0.027) but without changes in diabetes burden or fear of hypoglycemia (Table 3). P-values for the change between 26 and 52 weeks within each of the CGM groups were all above 0.05. At 52 weeks, parents in the CGM+FBI group tended to report less diabetes burden and less fear of hypoglycemia overall compared to the standard-CGM group; however differences were not statistically significant, as the confidence intervals for the treatment group differences were wide and did not exclude zero (Table 3). Sensitivity analysis including age, diabetes duration, and annual household income as covariates in the model produced similar results.
Table 3:
Psychosocial Outcomes at 12 Months in the Groups Receiving Continuous Glucose Monitoring (CGM) During First 26 Weeks
| CGM + FBI |
Standard CGM |
Treatment Group Difference at 52 Weeks CGM+FBI – Standard-CGM (95% CI) [P-value]1 |
|||||
|---|---|---|---|---|---|---|---|
| N | Mean ± SD | Change from Baseline to 52 Weeks (95% CI) [P-value]1 |
N | Mean ± SD | Change from Baseline to 52 Weeks (95% CI) [P-value]1 |
||
| PAID-PR | |||||||
| Baseline | 45 | 45 ±17 | 41 | 48 ±15 | |||
| 26 Weeks | 42 | 39 ±19 | 41 | 52 ±16 | |||
| 52 Weeks | 42 | 39 ±19 | 41 | 48 ±16 | |||
| Change from Baseline to 52 Weeks | 42 | −5.5 ± 14.8 | −6.2 (−10.6, −1.7) [0.010] | 40 | −0.7 ± 14.4 | −0.6 (−5.4, 4.2) [0.78] | −5.6 (−13.9, 2.7) [0.47] |
|
| |||||||
| HFS Total | |||||||
| Baseline | 44 | 40 ±17 | 40 | 44 ±17 | |||
| 26 Weeks | 42 | 35 ±15 | 40 | 44 ±16 | |||
| 52 Weeks | 42 | 35 ±15 | 41 | 42 ±18 | |||
| Change from Baseline to 52 Weeks | 41 | −4.6 ± 15.9 | −5.8 (−10.1, −1.5) [0.010] | 39 | −2.4 ± 16.3 | −1.5 (−6.9, 3.9) [0.69] | −4.3 (−12.8, 4.2) [0.49] |
|
| |||||||
| HFS Worry | |||||||
| Baseline | 44 | 37 ±22 | 40 | 41 ±22 | |||
| 26 Weeks | 42 | 31 ±19 | 40 | 41 ±21 | |||
| 52 Weeks | 42 | 30 ±19 | 41 | 38 ±22 | |||
| Change from Baseline to 52 Weeks | 41 | −6.7 ± 22.4 | −7.7 (−13.5, −1.9) [0.010] | 39 | −4.6 ± 23.6 | −2.6 (−9.8, 4.7) [0.69] | −5.1 (−16.4, 6.1) [0.49] |
|
| |||||||
| DTQ Now | |||||||
| Baseline | 45 | 56 ±17 | 42 | 50 ±18 | |||
| 26 Weeks | 42 | 62 ±19 | 40 | 53 ±17 | |||
| 52 Weeks | 42 | 61 ±22 | 41 | 58 ±18 | |||
| Change from Baseline to 52 Weeks | 42 | 3.9 ± 17.6 | 4.8 (−0.7, 10.3) [0.08] | 41 | 8.5 ± 17.4 | 7.3 (0.6, 14.0) [0.027] | −2.5 (−12.5, 7.5) [0.86] |
|
| |||||||
| DTQ Change | |||||||
| 26 Weeks | 42 | 73 ±17 | 40 | 69 ±12 | |||
| 52 Weeks | 42 | 74 ±18 | 41 | 73 ±11 | 1.4 (−7.5, 10.3) [0.88] | ||
|
| |||||||
| DFI-S | |||||||
| Baseline | 44 | 20 ±13 | 41 | 26 ±16 | |||
| 26 Weeks | 41 | 21 ±15 | 40 | 24 ±15 | |||
| 52 Weeks | 42 | 19 ±14 | 41 | 24 ±19 | |||
| Change from Baseline to 52 Weeks | 41 | 0.6 ± 9.5 | −1.4 (−4.7, 1.9) [0.39] | 40 | −1.4 ± 14.2 | −1.1 (−5.9, 3.8) [0.69] | −0.4 (−7.8, 7.1) [0.89] |
|
| |||||||
| WHO-5 | |||||||
| Baseline | 44 | 66 ±16 | 40 | 67 ±18 | |||
| 26 Weeks | 42 | 67 ±18 | 41 | 65 ±15 | |||
| 52 Weeks | 41 | 67 ±19 | 41 | 67 ±17 | |||
| Change from Baseline to 52 Weeks | 40 | −0.4 ± 14.2 | 0.0 (−4.5, 4.5) [0.99] | 39 | 0.6 ± 21.9 | 1.1 (−5.2, 7.5) [0.69] | −1.1 (−10.8, 8.6) [0.88] |
From a repeated measures linear regression model of baseline, 26 weeks, and 52 weeks adjusted for baseline HbA1c and clinical site as a random effect. P-values and confidence intervals are adjusted for multiple comparisons to control the false discovery rate (FDR).
Previously published data indicated persistently high CGM use in all groups (all >88%), and no change in time-in-range or HbA1c with CGM use in any group [18].
DISCUSSION
The SENCE study developed and tested a structured family-focused education and support intervention addressing behavioral and emotional challenges of new CGM use for parents of very young children with type 1 diabetes. The trial demonstrated multiple psychosocial benefits of this intervention approach, with patterns of responses over 1 year suggesting lasting positive effects.
Importantly, we replicated the short-term benefits previously reported in the CGM+FBI group from weeks 0-26 [17] in the BGM-Crossover group, including reductions in burden and fear of hypoglycemia following 6 months of CGM use with FBI. Caregivers of young children with diabetes are generally fully responsible for managing their child’s glucose levels, often without feedback on symptoms or assistance from the child. This can be a source of burden and fear in parents, and can lead to burnout, mood disorders, and other psychosocial concerns [2, 3, 5, 12]. A relatively brief educational and behavioral program, delivered by trained non-medical study staff, focused on common challenges related to CGM use appears to provide support in helping parents manage their psychosocial concerns and equip them with skills to engage with diabetes care and diabetes technologies without adding burden.
This study suggests long-term benefits to tailored education and behavioral support for parents. In examining the CGM+FBI group’s psychosocial outcomes at 52 weeks, patterns were similar to those reported at the earlier 26 week endpoint [17]. Notably, psychosocial outcomes suggested modest improvement at 52 weeks that did not reach the threshold for statistical significance; this is likely due to inadequate power for these secondary analyses. However, the lack of deterioration in burden and fear of hypoglycemia scores between week 26 and 52 suggests that the positive effects of the FBI were maintained long past the intervention. The potential lasting benefits in the second 6-month observation period were evident in that the scores were largely stable from 26 to 52 weeks.
As parents’ stress is likely present even as their child ages [27, 28], the potential to reduce these challenges longer-term using a FBI approach is promising. Notably, the Standard-CGM group, despite never receiving the FBI, also showed an increase in technology satisfaction over time. This may be attributable to an increase in familiarity, experience, and subsequent adjustment as parents continued device use for longer, even without targeted behavioral support. Given that technology satisfaction increased quickly following FBI in the other groups, it is possible that comprehensive education and support conducted early in CGM initiation may increase satisfaction more quickly. Increased technology satisfaction may reduce likelihood of discontinuation [29].
There are some limitations and strengths to consider in interpreting the results of the current study. First, this study was conducted using the Dexcom G5, which was the available sensor version at study start. Since the sensor required twice-daily calibrations with fingerstick glucose monitoring to ensure accuracy, the perceptions of burden may not translate directly to users’ experiences with newer CGM models that do not require calibration. Second, the HbA1c criteria for participation may limit generalizability, as families with children with higher or lower HbA1cs may experience different barriers or burdens than the participants in this sample, and any intervention may need to be adapted to target those concerns. However, the range of 7-10% (53-86 mmol/mol) captures most young children with type 1 diabetes [30], making it largely applicable to the majority of families of children using CGM. Further, our sample was not adequately powered to identify possible predictors of psychosocial change. This is an important area of future research, to better understand the current benefits and future revisions needed to meet the needs of more parents of young children with type 1 diabetes. Finally, a strength of the study was its large and racially/ethnically, socio-economically, and geographically diverse sample. The consistency of our findings, from the original 26-week trial to the 52-week extension phase, in a highly diverse sample underscore the likelihood of the FBI having a broadly relevant psychosocial benefit for families of young children with diabetes despite varying resources.
The provision of CGM education plus behavioral support can likely enhance the benefits of technology use in young children and their parents by addressing their psychosocial needs in known areas of difficulty with technology use. Future iterations of the intervention may be needed to address novel challenges and burdens related to technology use as CGM features continue to advance and hybrid closed-loop systems become more widely available. Additional attention to the use, benefits, and challenges of remote monitoring is also warranted. The results of the current study are promising in facilitating adjustment and satisfaction with CGM technology in parents of very young children.
Supplementary Material
Novelty Statement:
Diabetes management in very young children (<8 years old) is uniquely challenging for caregivers, and continuous glucose monitoring (CGM) has potential to reduce caregiver diabetes management burdens.
Twelve-month outcome data from the Strategies to Enhance New CGM Use in Early Childhood (SENCE) study demonstrated that CGM initiation complemented by structured CGM education and behavioral support for parents improved caregiver burden and fear of hypoglycemia after 26 weeks. Scores remained similar at 52 weeks.
Family-focused education with behavioral support with CGM initiation holds promise in addressing parents’ psychosocial barriers to technology use in young children with type 1 diabetes.
Funding:
This study was supported by The Leona M. And Harry B. Helmsley Charitable Trust. Dexcom provided nonfinancial support in the form of devices. Drs. Hilliard and Anderson received complementary support from the National Institutes of Health (1K12 DK097696, PI: Anderson). Drs. Commissariat and Laffel receive support from NIH P30DK036836.
Conflict of Interest Disclosure:
PVC, LGK, BJA, and MEH have no conflicts of interest. LAD serves as a consultant to Vertex and receives research support to her institution from Dompe, Lilly, Mannkind, Medtronic, and Provention. LML serves as a Consultant/Advisor for Janssen, Boehringer Ingelheim, Medtronic, Dompe, Provention, Eli Lilly, Roche, and Dexcom. KMM has served as a consultant to Dexcom and has received donations of devices from Dexcom for studies funded by Helmsley Charitable Trust.
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