Intermittently Scanned and Continuous Glucose Monitor Systems: A Systematic Review on Psychological Outcomes in Pediatric Patients

Aim: To explore the impact of real-time continuous glucose monitoring (rtCGMs) or intermittently scanned/viewed CGM (isCGM) on psychological outcomes in children and caregivers, and to grade the level of evidence.

Method: Systematic review of the literature from PubMed, Embase, Cochrane Library, Web of Science, CINAHL, Nursing reference center, Up to date, Google Scholar, and PsycINFO databases. The studies selected used validated questionnaires for investigating the psychological outcomes. We applied GRADE (Grading of Recommendations Assessment, Development and Evaluation) to rank the quality of a body of evidence.

Results: A total of 192 studies were identified in the initial search and after the process of evaluation 25 studies were selected as appropriate to be included in this systematic review. We found in moderate quality studies that isCGM in adolescents can improve diabetes related distress, family conflicts, fear of hypoglycemia, and quality of life, while depression, anxiety, and quality of sleep have not yet been evaluated by validated questionnaires. In moderate—high quality studies, rtCGM technology does not impact on diabetes burden, diabetes specific family conflict, and depressive symptoms. The effect on fear of hypoglycemia, sleep quality, and anxiety is still debated and RCT studies powered to find significant results in psychological outcomes are lacking. RtCGM increases satisfaction and quality of life in parents and patients wearing rtCGM.

Conclusion: these data present an interesting point to consider when families are deciding whether or not to start CGM use, choosing between rtCGM to reach a tighter metabolic control, or isCGM which allows greater benefits on psychological outcomes.

Introduction

The advent of real-time continuous glucose monitoring systems (rtCGMs) or intermittently scanned/viewed CGM (isCGM) is one of the major technological innovation for the treatment of Type I Diabetes (T1D). Real-time CGM allows individuals with diabetes to follow their glucose concentration simultaneously, and to obtain information on glucose trends and trajectories. Moreover, the systems can provide warnings on upcoming hypoglycemia or hyperglycemia as well as alarms for rapid glycemic excursions (1). Meta-analyses provided evidence for real-time CGM to lower hemoglobin A1c (HbA1C) levels without increasing hypoglycemic events (1).

Importantly, recent studies confirmed that the use of isCGM has a positive impact on glucose control, by limiting glucose variability, reducing hypoglycemia, and improving long-term glucose control (2).

In addition to the stand-alone rtCGM systems, the integrated combination of pump therapy with rtCGMs allows to automatically suspend insulin delivery in the case of upcoming hypoglycemia, thus reducing or avoiding nocturnal hypoglycemia (3).

Although a clear evidence that the benefits associated with the use of rtCGMs are strictly related to a near daily use (1, 4, 5), a constant rtCGM use remains problematic for many patients in the pediatric age group (6, 7). Indeed, a better glycemic control is achieved by patients who use rtCGM for the majority of time, generally considered to be 70% or more (1, 8). Nevertheless, recent data from the Type 1 Diabetes Exchange Clinic Registry still reports that only one third of T1D-affected youth regularly wears rtCGM, although there has been an increase of use from 2013 (4% of T1D youth) to 2015 (14%) and 2017 (31%) (9). Furthermore, rtCGM wearing declines significantly over-time among T1D users (10). Barriers to a regular rtCGM use in pediatrics are reported in the following Table:

A deeper understanding of the factors related to technologies uptake and adherence remains a crucial topic of investigation. In particular, studies on psychological factors that may predict sensor success or interruption are still limited. On the contrary, identifying psychological issues related to the sensor use would support both diabetologists in tailoring the best treatment for each patient, and youth and families in setting realistic expectations. The impact of rtCGM and isCGM on psychological outcomes in children and caregivers remains controversial (6, 14, 15). This may be due to the fact that psychological measures are usually considered as secondary outcomes in trials involving CGMs (Laffel LM 2020 JAMA, Massa GG 2019, JDRF-CGM Study Group, Diabetes Care 2010), compared to the metabolic control (HbA1c, hypoglycemia, CGM glucose metrics). Moreover, different questionnaires are used to assess the outcomes in the published studies. Also, each area of investigation (depression, fear of hypoglycemia, QoL) could be explored by different validated measures, self-reported or administered by health care providers, as summarized in Table 1 (16–42).

TABLE 1

Table 1. Review of psychological measures in children used in the studies, sorted by outcome.

Aim

The aim of this systematic literature review is to explore the impact of rtCGM or isCGM on psychological outcomes (diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality, quality of life, and satisfaction with the CGM system) in children and caregivers and to grade the level of evidence.

Methods

Criteria for Study Selection

Types of Studies

We included RCTs, observational studies, prospective studies, cross-sectional studies, exploratory studies, mix of qualitative, and quantitative studies. We included only published studies.

Types of Participants

We included patients with T1D aged between 0 and 18 years and their caregivers.

Types of Interventions

We included the following comparisons:

Comparison 1: rtCGM on psychological outcomes (diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality and quality of life, satisfaction) vs. capillary glucose testing for glycemic assessment in children and caregivers;

Comparison 2: isCGM on psychological outcomes (diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality and quality of life, satisfaction) vs. capillary glucose testing for glycemic assessment in children and caregivers.

Comparison 3: rtCGM vs. isCGM on psychological outcomes (diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality and quality of life, satisfaction) in children and caregivers.

Outcomes

Psychological outcomes in children and caregivers included: diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality, quality of life, satisfaction.

A detailed description of outcomes and related measures is reported in Table 1 (16–42).

Search Methods

We conducted a systematic search of the literature according to the PICOS model (Population, Intervention, Comparison, Results, Study design).

The study exclusion criteria were:

- patients >18 years; patients with Type II Diabetes;

- studies not meeting the established primary and secondary outcomes;

- animal research studies;

- devices: use of closed loop systems;

- reviews, conference abstracts, full texts not available.

We did not apply language restrictions.

Sources used for literature review included: PubMed, Embase, Cochrane Library, Web of Science, CINAHL, Nursing reference center, Up to date, Google Scholar, and PsycINFO.

Articles published from 1/01/2006 to 31/12/2020 were considered for the current review. Search terms, or “mesh” (MEdical Subject Headings) for this systematic review included: “CGM AND distress,” “CGM AND sleep quality,” “CGM AND psychological variables,” “Glucose monitoring AND distress,” “Glucose monitoring AND sleep quality,” “Glucose monitoring AND psychological variables,” “Flash glucose monitoring AND distress,” “Flash glucose monitoring AND sleep quality,” “Flash glucose monitoring AND psychological variables.”

According to the PICOS detailed above, filters for participants' age (0–18 years), and study characteristics were activated.

Data Extraction and Management

Two review authors independently extracted data by using the forms integrated in the sources' systems.

The following characteristics were reviewed for each included study:

• reference aspects: authorship(s); published or unpublished; year of publication; year in which study was conducted; other relevant papers cited;

• study characteristics: study design; type, duration; informed consent; ethics approval;

• population characteristics: age, number of participants;

• intervention characteristics: type, duration, mode of use of rtCGM and isCGM;

• evaluation of the outcomes as reported in Table 1 (16–42).

Disagreements were solved by discussion.

Assessment of the Certainty of the Evidence

We used the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) to rank the quality of a body of evidence (www.gradeworkinggroup.org) for the following outcomes: diabetes distress/burden, diabetes-specific family conflicts, depressive symptoms, anxiety, fear of hypoglycemia, alarm fatigue, impaired sleep quality, quality of life, and satisfaction with the rtCGM and the isCGM systems.

Two review authors independently assessed the certainty of the evidence for each of the outcomes above. In the case of risk of bias in the study design, imprecision of estimates, inconsistency across studies, indirectness of the evidence, and publication bias, we had the option of decreasing the level of certainty by one or two levels according the GRADE guidelines (43).

The GRADE approach results in an assessment of the certainty of a body of evidence and allocation to one of four grades:

Results

A total of 192 studies were identified following the literature review. After screening, we excluded 20 records as they were duplicates. When we reviewed titles and abstracts we excluded 112 records: 9 studies were published only in abstract form, 100 studies did not investigate the outcomes of interest (Table 1), 3 studies were not available in the full text form.

A total of 60 full-text manuscripts were assessed for eligibility: 27 studies were excluded as no data were available for the analysis, besides the ones reported in the abstracts; 4 studies were excluded as they reported data from the same cohort of patients; 4 studies were excluded as they resulted to be literature reviews when the full-texts were analyzed. A final number of 25 studies, 6 on isCGM, 19 on rtCGM, were included in this systematic review.

The PRISMA flow diagram in Figure 1 shows the process of study evaluation.

FIGURE 1

Figure 1. Preferred Reporting Items for Systematic Reviews (PRISMA) flow diagram showing the progress of studies through the review.

A summary of results from the studies included in this systematic review is reported in Tables 2, 3.

TABLE 2

Table 2. Analysis of the 25 papers included in the systematic review.

TABLE 3

Table 3. Summary of the evidence: rtCGM and isCGM impact on psychological outcomes in children (and parents/caregivers where specified).

Distress/Diabetes Burden

This outcome is analyzed in 3 studies on isCGM use and in 12 studies on rtCGM use in youth and their caregivers.

In pediatric patients isCGM reduced psychological distress for all the domains analyzed during a 12-weeks prospective study in children/adolescents [(44), Moderate] and in a 4-weeks qualitative study in adolescents/young adults [(45), Low]. This effect was reported also in parents of children and adolescents in a qualitative study [(46), Low].

RtCGM reduced diabetes burden in adolescent patients according to a cross-sectional study [(47), Moderate]. A similar effect was described for caregivers in five studies [(48–50), Low, (47, 51), Moderate]. In two studies no variation in diabetes burden was found both in children and caregivers [(13, 14), High-Moderate]. Broad effects were highlighted in three studies [(52–54), Moderate-Low].

Family Conflict in the Management of Diabetes

This outcome is measured in 2 studies on isCGM use and in 5 studies on rtCGM use in youth and their caregivers.

IsCGM use was associated with a reduction in diabetes specific parent-child conflict and parental conflict in patients aged 13–20 years in 2 qualitative studies [(45, 46), Low].

RtCGM use was associated with both a reduction in family conflicts and an improvement in rtCGMs related family functioning in 2 studies included in the review [(51, 55), Moderate]. These benefits were related to a decrease in the workload associated to blood glucose monitoring (BGM) and to an increased sense of safety [(51), Moderate]. In a RCT very similar levels of family conflict between the intervention group (rtCGM) and the control group (BGM) were found [(52), Moderate]. In other two studies no differences in family conflict were reported after the initiation of rtCGM use [(13, 53), Moderate]. The perception of a high number of obstacles and barriers related to the use of rtCGM sensors is related to a greater number of family conflicts and difficulties in managing the disease [(53), Moderate].

Depression

Depression in youth using rtCGM is evaluated in two studies. In a cross-sectional study on rtCGM use in adolescents, more depressive symptoms were reported by those who faced more barriers [(53), Moderate]. In a RCT in children 8–17 years old, rtCGM parent-proxy report of depression was significantly higher than that reported by BGM parents [(52), Moderate]. Data on depression in youths using isCGM are lacking.

Anxiety

This outcome is measured in 3 studies on rtCGM use in youth. In a RCT evaluating children in the age 2–12 years and their parents, parental stress level was lower in the arm using rtCGM compared to the control group (51, Moderate). In another study including 16 children aged 2–17 years, rtCGM use was associated with an improvement in children and parents' anxieties [(56), Low].

In a RCT study, the group of youth with rtCGM reported more trait anxiety than BGM youth, whereas rtCGM adults reported less state and trait anxiety than BGM adults [(52), Moderate].

Data on anxiety in youths using isCGM are lacking.

Fear/Worry of Hypoglycemia

This outcome is measured in 1 study on isCGM use and in 14 studies on rtCGM use in youth.

Fear of hypoglycemia (FOH) was reduced by isCGM use in adolescents older than 12 years in a 3-month prospective study [(59), Moderate]. Similarly, rtCGM use reduced FOH in 16 children aged 2–12 years in a 12-month cohort study [(56), Low]. Likewise, fear associated with hypoglycemic events resulted significantly lower in parents of youth using rtCGM in several studies [(51, 57, 58), Moderate, (56), Low]. RtCGM reduced the fear of nocturnal hypoglycemia in youth when integrated with a pump that automatically suspend insulin delivery in case of hypoglycemia [(54), Low].

On the contrary, in several studies no differences were found in FOH in both youth using rtCGM/isCGM [(13, 14, 52, 57), Moderate-High] and their caregivers [(6, 13, 14, 52, 60), Moderate-High]. The fear of hypoglycemic events resulted higher in parents than in children [(52), Moderate] although the sensor use. This is probably related to the fact that not all parents have full confidence in rtCGM systems: some parents are worried that the sensor may not work properly and it does not intercept hypoglycemic events [(53), Moderate].

Sleep Quality

This outcome is measured in 7 studies on rtCGM use in youth. In an observational study, overall 67% of children with T1D met the criteria for poor sleep quality; a worse child sleep quality was associated with worse metabolic control and poorer parental sleep quality. Child sleep was not related to the use of diabetes-related technology (rtCGM, insulin pump) [(58), Moderate]. About caregivers, most experimented better sleep patterns with rtCGM [(51, 54), Low-Moderate], while others reported disturbed sleep due to the presence of alarms and to the fear of hypoglycemia [(49), Low].

In a qualitative study, 9 pairs of children and parents reported improved sleep quality with the sensor use [(61), Low]. A prospective study on 46 children and their parents found that kids who used rtCGM experienced fewer sleep disturbances than those who did not, but their parents had greater sleep disturbances related to a higher frequency of nocturnal blood glucose monitoring (NBGM) [(62), Moderate]. A RCT on youth aged 14–24 years using rtCGM, reported there were no differences in sleep quality between sensors users and non-users [(60), High]. Data on sleep quality in youths using isCGM are lacking.

Alarm Fatigue

This outcome is measured in 5 studies on rtCGM use in youth. Parents of children aged 3–17 years using rtCGM reported both positive and negative responses for alarms: helpful when signaling hypoglycemia but annoying when repeatedly sounding during the night; thus, most parents reported they would like to louder alarms [(54), Low]. In a qualitative study, most parents reported clear clinical and psychological benefits associated with alarms alerting, but others noted that alarms could interfer with daily activities in the workplace or at school [(61), Low]. While alarms could reinforce a sense of hypoglycemic safety, some individuals expressed ambivalent views, especially those who perceived alarms as signaling personal failure to achieve optimal glycemic control [(61), Low]. Two additional studies included in the review highlighted that alarms can often cause annoyance and discomfort [(53, 63), Moderate].

Day caregivers, teachers or school nurses, generally appreciate alarm systems and these are not perceived as a source of distraction or disturbance but as a tool that simplifies the management of the disease [(48), Low].

Quality of Life/Well-Being

Four studies reported on this outcome in patients with isCGM, as well as 9 studies in patients with rtCGM. The use of isCGM has been reported to improve QoL in children and adolescents [(59, 64), Moderate] as well as in their parents [(46, 65), Moderate-Low].

RtCGM systems has been reported to improve QoL in children, for easier management of insulin dosages, diet, physical activity and in school and extra-home management [(54, 55, 62), Moderate-Low]. Similarly, in parents of youths, rtCGM has been reported to improve QoL and well-being [(51, 56), Moderate-Low].

In 3 studies included in this review no variations in QoL were found after rtCGM intervention [(13, 14, 63), Moderate-High] in youths and their parents.

Parents scores regarding the QoL are significantly higher (indicative of a less favorable QoL) than the youth's one, confirming that the perception of parents regarding the QoL of their children is less favorable than the prospects of youth regarding their QoL [(63), Moderate]. Moreover, parents/caregivers compared to partners, reported more negative emotions and decreased well-being related to their family members with T1D [(49), Low].

Satisfaction

This outcome is measured in 7 studies on rtCGM use in youth. Most patients using rtCGM and their parents reported high treatment-related satisfaction [(49, 57, 61), Low-Moderate].

Three RCTs of high quality confirmed the satisfaction with rtCGM use (6, 14, 60). In the first RCT, 90% of parents of 4–9 years old children, reported a high degree of satisfaction with rtCGM: the use of rtCGM makes adjusting insulin easier, shows patterns in blood glucose not seen before, and makes them feel safer knowing that they will be warned about low blood glucose before it happens [(6), High]. In the second RCT, patients aged 14–24 years using rtCGM, reported higher glucose monitoring satisfaction compared to the BGM group over a 26-weeks study period [(60), High]. In the third RCT, in patients aged 7–17 years, satisfaction scores at 26 weeks were higher for both, youths and parents, with higher scores associated with a more frequent use of rtCGM [(14), High].

In a cross-sectional study using qualitative and quantitative methods, parents and caregivers of children aged 2–17 years, felt positive about rtCGM use [(48), Low].

Data on satisfaction in youths using isCGM are lacking.

Discussion And Conclusions

A large percentage of pediatric patients with T1D experiences negative emotions, including state of anxiety, fear, discouragement, and frustration for the burden of the disease management. The use of CGM systems improves glycemic control (60) but demands for extra efforts from patients and their parents. Therefore, it is important to assess if the use of rtCGM and isCGM systems is related to psychological issues (52).

Studies on how isCGM and rtCGM impact the psychological outcomes in children and their caregivers were evaluated in this systematic review. Some limitations of the revised studies need to be addressed (Table 2):

(i) the sample size resulted small or not representative of the general population is some studies; (ii) psychological measures were included as secondary outcomes in most of the studies; thus, in some cases, the study design was not adequate to support significant results; (iii) some of the questionnaires used to measure the psychological outcomes were not previously validated. Also, questionnaires varied from one study to another.

Data on psychological outcomes in the pediatric population using isCGM systems are still limited, probably due to their recent availability on the market. The use of isCGM in adolescents can reduce psychological distress, family conflicts and fear of hypoglycemia (44, 59) and improves QoL (59, 65) as reported by a Saudi Arabia group (44) in moderate quality studies. Currently, there is no evidence of a negative impact of the isCGM system on the psychological outcomes evaluated in this review. However, results from our literature review highlighted the lack of data on depression, anxiety, and quality of sleep in pediatric patients using isCGM.

Most of the studies reported that the use of rtCGM did not increase diabetes burden in adolescents and their parents/caregivers with a moderate-high quality of evidence and using the PAID-T and P-PAID-T questionnaires (6, 13, 14, 52, 60). Likewise, rtCGM did not impact the diabetes specific family conflict, as measured by DFRQ and DFCS questionnaires in a moderate quality study (13, 52). Furthermore, rtCGM did not change depressive symptoms assessed with CDI, CES-D (13), and PHQ8 questionnaires (53).

On the other hand, rtCGM resulted improving parental anxiety in a moderate quality RCT using the STAI questionnaire by Burckhardt et al. (51). However, these results were not confirmed in a moderate quality observational study using the same questionnaire, by Giani et al. (13).

Fear of hypoglycemia remains the most common diabetes-related issue among T1D, both for youth and their parents/caregivers. In a RCT (51), parental fear of hypoglycemia (FOH) evaluated by the HFS score resulted lower in the group using rtCGM. However, other moderate-high quality studies using the HFS and HCS questionnaire did not confirm this outcome (6, 13, 14, 60).

In a RCT, adolescents' sleep quality measured with the PSQI questionnaire was not different in youth using rtCGM (60). On the contrary, parental sleep quality improved with the use of rtCGM, both when measured with the PSQI questionnaire as well by accelerometry devices in parents of adolescents and of young children, respectively (62).

Alarm fatigue was broadly evaluated in patients using rtCGM by non-validated interviews. In most cases, individuals reported clear clinical and psychological benefits to alarms setting (61), but in some contexts alarms resulted annoying and intrusive (53).

In most of the studies the perceived QoL assessed by the PedsQL in patients and caregivers, resulted improved by the use of rtCGM (55, 62). In some other studies no variations in the PedsQL were reported (13, 14), probably due to the number of variables that may influence the perceived QoL in diabetes or due to the short-term follow-up. An increased satisfaction related with the rtCGM use was assessed in both parents and youth with the DTSQ, CGM-SAT, and GMS questionnaires in moderate-high quality studies (6, 14, 51, 60).

In conclusion, the benefits of isCGM and rtCGM use on glycemic control have been previously demonstrated (1, 2, 66, 67). Findings from the studies included in this systematic review suggest that: (i) the use of isCGM in adolescents can improve diabetes related distress, family conflicts, FOH and perceived QoL; depression, anxiety, and quality of sleep have not yet been evaluated with validated questionnaires; (ii) the use of rtCGM does not impact diabetes burden, diabetes specific family conflict and depressive symptoms. The effect of rtCGM use on the fear of hypoglycemia, the sleep quality and the anxiety is still debated. Further RCT studies specifically powered to investigate psychological outcomes are needed. The use of rtCGM increases both satisfaction and perceived QoL in youth and their parents, although alarm fatigue need to be prevented with alarm targeting.

Altogether, these findings represent an interesting overview to consider when families are in the process of deciding whether or not to start CGM use.

Data Availability Statement

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Author Contributions

RF and FM made a substantial contribution to the design of this literature review, in the acquisition of data, and their interpretation and analysis as well as in the writing of the manuscript. FM and RF selected the articles of this literary review. VC, MS, EM, and EG contributed to the critical revision of the manuscript for intellectual reasons and performed a thorough proofreading of the manuscript. All the authors have definitely approved the version to publish.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Abbreviations

T1D, type 1 diabetes; DRD, diabetes related distress; FOH, fear of hypoglycemia; QoL, quality of Life; HRQoL, health related quality of life; BG, blood glucose; BGM, blood glucose monitoring; isCGM, intermittently scanned/viewed CGM; CGM, continuous glucose monitoring; FGM, flash glucose monitoring; CSII, Continuous subcutaneous insulin infusion; PLGM, predictive low glucose management.

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