Table 2.
Analysis of the 25 papers included in the systematic review.
| References | Main objective | Characteristics | Methodology | Main results—outcomes | Limits of the study and evidence level |
|---|---|---|---|---|---|
| Al Hayek et al. (44) | Effect of isCGM on DRD | 12-week prospective study 187 children and adolescents (13–19 years) with T1D, using the conventional fingerprick method. 31% were on CSII Region: Saudi Arabia | At baseline sensors were fixed. T1-DDS (diabetes distress) questionnaire was administered at T0 and + 12 weeks | T +12 weeks, in comparison to the baseline (fingerprick) showed significant decrease in all the seven the subdomains and in total T1-DDS (diabetes distress score). Increased frequency of glucose monitoring with isCGM. Substantial drop in HbA1c and in the frequency of hypoglycemia was observed. | Lack of a control group; limited number of risk factors assessed. - Moderate - |
| Boucher et al. (45) | Early experiences with isCGM | 4 week qualitative study 15 participants with T1D (age 13–20 years) Device: isCGM Region: New Zeeland | Interviews 1-month from starting the isCGM. The interview analyzed: -Impacts of isCGM -Facilitators and challenges of using isCGM -Supporting patients in using isCGM | Participants perceived isCGM to be easy to use and discrete. All participants reported that isCGM alleviated burden of managing diabetes. Most (n = 12/15) participants perceived an improvement in their diabetes self-management. Other benefits: Facilitate to do insulin all the time Improved concentration Increased physical activity Improved sleep: reduced nocturnal hyperglycemia and helps to identify how to prevent reoccurring nocturnal hypoglycemia Less parental conflict Reduces worry about glucose level Improved social life Barriers: the most common challenges of isCGM use were: premature sensor loss, forgetting to scan, skin irritation, technical problems. All participants anticipated continuing to use isCGM |
This finding may not be generalizable to longer periods of use. The sample may not be representative of the general population - Low - |
| Boucher et al. (46) | Parental perspectives after isCGM start. | Qualitative study 12 parents (age of children and adolescents with T1D: 13–20 years) Device: isCGM 11% of children used CSII Region: New Zeeland |
A interview explored: -Impacts of isCGM -Facilitators/challenges of using isCGM -Supporting patients in using isCGM | The following themes were identified: (1) improved parental well-being: “peace of mind” while their adolescent slept; reduced diabetes-specific worry and improvement in sleep quality (2) reduced diabetes-specific parent–child conflict (3) facilitated parental role in management: easier to perform glucose checks; helped guide treatment decision isCGM has the potential to reduce diabetes management burden for both adolescents and parents. Barriers: premature sensor loss and sensor malfunction, isCGM costs. |
Limitation were the small sample size. The parents included in this study were predominantly of European ethnicity and the findings may not apply to minority populations. - Low - |
| Vesco et al. (47) | Diabetes technology use on adolescent and DRD | Cross-sectional study. Adolescents with T1D (12–18 years) and parents (N = 1,040; primarily mothers) 64% were on CSII, 11% rtCGM+CSII Region: USA | Adolescents were categorized by technology use: rtCGM Alone, CSII Alone, rtCGM+CSII, or No Technology Adolescents (PAID-T) and parents (P-PAID-T) completed an online questionnaire | Adolescents: rtCGM use was associated with less DRD compared to No Technology, rtCGM+CSII and CSII Alone Parents: results were similar but with smaller effect size for parent-reported distress rtCGM Alone was associated with lower HbA1c compared to No Technology CSII alone and CSII+rtCGM Alone was associated with lower HbA1c compared to No Technology. rtCGM+CSII gave advantage over CSII Alone. |
The sample was composed of mostly Caucasian participants from higher income families which is not representative of all youth with T1D. Small number of participants in the rtCGM Alone technology use group. - Moderate - |
| Erie et al. (48) | rtCGM practices in homes and schools, attitudes and expectations of parents and caregivers | Cross-sectional, using quantitative and qualitative methods Parents and daytime caregivers (school nurse, daycare teacher, nanny). Age of the children cared for by the respondents was 2–17 years 32 patients wore Dexcom® G4 or G5 sensors and 1 patient wore a Medtronic Enlite® Sensor Region: USA | Anonymous survey assessing characteristics of rtCGM use 57 survey pairs were distributed. 33 parents and 17 daytime caregivers responded | All parents and most caregivers (78%) reported decreased overall worry/stress. Parents felt positive about rtCGM use, it brought them peace of mind and a sense of security. Daytime caregivers felt comfortable with rtCGM and many of them felt that use of these systems allowed to work in a collaborative manner with parents to provide intensive diabetes management Frequency of sensor use was very high with 94% of respondents stating their child used the sensor 7 days a week | Relatively small sample size and response rate of 58% amongst parents and 1/3 of daytime caregivers Respondents were extremely adherent to sensor technology - Low - |
| Barnard et al. (49) | Impact of diabetes-related technology in spouses and caregivers of people with T1D | Survey, quantitative, and qualitative mix 100 parents/caregivers and 74 partners 83% of children and 72% of adults were on CSII |
Participants were recruited via the Glu online community website. Online questions (PAID-5, WHO-5) and specific questions exploring the impact of technology | High use of rtCGM in both groups-partners and parents/caregivers. Parents/caregivers reported more negative emotions and decreased well-being related to their family members T1D, compared to partners, DRD was common, as was sleep disturbance associated with device alarms and fear of hypoglycemia. 87% of partners and 66% of parents/caregivers rated their own QoL as good Disrupted sleep was commonly reported with 73% of parents/caregivers and 59% of partners reporting waking because of diabetes technology. Of these, 54% of parents/caregivers and 12% of partners reported waking at least 4 times a week. The main reasons reported were rtCGM alarms and fear of hypoglycemia. False alarms were uncommon with 26 and 23%, respectively. | This study reaches only participants who are members of the Glu community (membership may be more tech savvy) as an online community - Low - |
| Kashmer et al. (50) | Characteristics of patients most willing to use rtCGM | Exploratory study Parents of children (0–18 years) with T1D responded to the online survey (no. 457) 70% used CSII Region: USA |
Online survey software was utilized to administer a 50-item questionnaire to parents of children with T1D. Primary outcomes were parental interest, attitudes and concerns | Only 12% of parents whose child had previously used a rtCGM Over 90% of the parents indicated a high level of interest in having their child use a rtCGM. Primary variables related to interest in rtCGM, were use of CSII, checking BG more than six times daily and parental worry about high or low BG. Age of the child and HbA1c were not related to parental interest in a rtCGM. Only a very few parents (6%) believed that using a rtCGM would increase their diabetes-related stress. Less than 2% of parents indicated believing that they would be overwhelmed Some (7%) were concerned that they would give too much or too little insulin if they saw glucose readings continuously. |
The survey instrument was not formally validated. - Low - |
| Burckhardt et al. (51) | Effect of rtCGM with remote monitoring on psychosocial outcomes in parents of children with T1D | RCT, two 3-month periods (participants spended 3 months in each of the two study arms) 49 children with T1D, 2–12 years, along with their parents |
Participants “naïve” for rtCGM At the first visit and after each 3-month period, parents and children (aged 8–12 years) completed: HFS, PedsQL, DASS, STAI, PSQI, RTCGM-SAT The primary outcome was parental HFS | Parental Hypoglycemia fear scores (HFS) were lower while the child was using rtCGM with remote monitoring. Parental health-related QoL and family functioning, stress, anxiety, and sleep measures also improved significantly after intervention | Relatively small sample size - Moderate - |
| Beck et al. (14) | Impact of rtCGM on QoL among individuals with T1D | Multicenter trial RCT, 26 weeks f/up 206 children and 228 adults with T1D 110 Children on rtCGM, 106 on capillary BG. Most on CSII |
HFS, PAID, SF-12 questionnaires were completed at baseline and 26 weeks by all participants and by parents (<18 years old). The rtCGM-SAT was completed by the rtCGM group (participants and parents) at 26 weeks. | Survey completion was high (rtCGM group: adults 98%, youth 93%, parents 97%; control group: 94–100%). There was substantial satisfaction with rtCGM technology after 26 weeks among participants and parents. QoL scores remained largely unchanged for both the treatment and the control group, although there was a slight difference favoring the adult rtCGM group on several subscales High baseline levels of QoL were found in this population No variation in parental burden associated with diabetes |
High baseline levels of QoL in the participants who were predominantly non-Hispanic white, well-educated, privately insured, and most commonly treated with insulin pumps at enrollment - High - |
| Giani et al. (13) | Biomedical and psychosocial factors associated with rtCGM use | 6 months observational study 61 T1D (8–17 years) and their parents 80% were treated with CSII Region: USA |
At the first visit and after 6 months period, patients and their parents completed: HFS, DFRQ, DFCS, CES_D, STAI-CP, PAID, P-PAID, PedsQL | There was no decline in any of the psychosocial factors At baseline parents of youth using rtCGM consistently reported higher QoL for their children than the parents of youth using rtCGM less often. Youth scores were lower than parent scores for parent fear of hypoglycemia, state anxiety, traitanxiety, and diabetes burden; were higher for youth generic QoL and youth diabetes-specific QoL Youth and parent scores were significantly positively correlated for parent involvement, diabetes-specific family conflict, diabetes burden, youth generic QoL and youth diabetes-specific QoL rtCGM use declined over the 6 months | Modest sample size; the study sample presented a large proportion of participants treated with CSII and high frequency of BG monitoring at baseline, relatively low HbA1c. Therefore, the results may not be generalizable to the general population of youth with T1D. - Moderate - |
| Markowitz et al. (52) | Impact of rtCGM on psychological variables that may influence diabetes treatment adherence | RCT Children (8–17 years old) and adults, randomized to the rtCGM or BGM group for 6 months. 86% were on CSII Region: USA | 49 participants were enrolled and completed at 0 and 6 months: HFS, PedsQL, SF-12, CDI, CES-D, STAI, BGM, DFCS, PAID | There were no differences in reported fear of hypoglycemia between rtCGM and BGM groups Parents in both groups reported significantly more FOH than youth. rtCGM youth and their parents and rtCGM adults reported more negative affect around BGM than the BGM group. rtCGM youth reported more trait anxiety than BGM youth, whereas rtCGM adults reported less state and trait anxiety than BGM adults. rtCGM parent-proxy report of depression was significantly higher than that reported by BGM parents. Reported levels of diabetes-specific family conflict were similar between groups. | This study was not powered to find significant result Moderate |
| Messer et al. (53) | Adolescent reported barriers to diabetes device use and to determine targets for clinician intervention | Cross-sectional study Survey on 411 adolescents (12–19 years) with T1D. 75% were on CSII Region: USA |
411 adolescents completed the survey. 225 (55%) were on rtCGM Online survey with PHQ-8, PAID-Peds, SEDM, and General Technology Attitudes Survey, the Diabetes Technology Attitudes Survey | Barriers: cost/insurance related concerns; wear related issues: hassle of wearing the device, dislike of device on body Adolescents who endorsed more barriers also reported more diabetes distress, family conflict and depressive symptoms Pump and rtCGM discontinuers both endorsed more barriers and more negative perceptions of technology than current users, but reported no difference from device users in diabetes distress, family conflict, or depression. | Potential underrepresentation of adolescents not using any diabetes technology or using intermittently scanned rtCGM - Moderate - |
| Pickup et al. (54) | To analyze narratives about experiences of real-time rtCGM in people with T1D | Qualitative study 50 children with T1D (3–17 years) using rtCGM and 50 caregivers Most participants (87%) used rtCGM+CSII Region: UK |
Online survey on rtCGM duration, frequency of sensor wear, funding and a free narrative about experiences or views about rtCGM. Qualitative framework analysis to analyze 100 responses was analyzed 71% used sensors ≥75% of the time | Experiences were overwhelmingly positive, with reported improved -sleep: most participants who mentioned sleep (81%) wrote that they were able to sleep more easily, with less disturbance, FOH, and a feeling of safety, with rtCGM -QoL, and physical and psychological well-being (reduced stress for patient and caregiver, reassurance and security, more confidence and independence, improved energy, mood, and QoL) -reduced frequency of SMBG Barriers: sensor inaccuracy and unreliability, and “alarm fatigue.” The advantages of rtCGM used with CSII with PLGM were recorded by several participants, noting reduced hypoglycemia frequency and fear of nocturnal hypoglycemia. |
Responses were based on perception Participants who were funded might tend to be biased toward the positive features of rtCGM to justify the funding. - Low - |
| Telo et al. (55) | Patient and family behavioral and clinical characteristics associated with rtCGM | Cross-sectional study 358 children with T1D (age 8–18 years) Device: rtCGM 70% of patients with rtCGM used CSII, and 84% of controls Region: USA |
Youth and their parents completed: DMQ, DFCS, DFRQ, PedsQL. | rtCGM group performed more frequent BGM; reported greater adherence to diabetes care; higher youth QoL; less diabetes-specific family conflict. No differences with respect to parent involvement in diabetes management. Patients who are already wearing CSII may be less reluctant |
Only 28% of eligible youth who were approached for the rtCGM study agreed to wear a rtCGM device compared with 66% of the eligible general pediatric population who were approached. This probably because they recognized potential burdens related to current rtCGM technology. - Moderate - |
| Ng et al. (56) | Effects of rtCGM on patient and caregiver well-being, worry, fear of hypoglycemia and glycemic control. | 12 months cohort study 16 children with T1D (age 2–17 years) Device: rtCGM (Dexcom G4®) All the patients were on pump therapy Region: United Kingdom |
Children aged >12 years completed the HFS Parents completed a modified version of the HFS-P12 | Improvement in fear of hypoglycemia (FOH), for both parents and children, were observed. rtCGM gave to parents and children the confidence to modify treatment regimen and rtCGM improved their anxieties, fear, and worry. rtCGM improved the children's and their parents' well-being. After 8 months follow up, 5 patients used rtCGM intermittently and up to 58% were not using their rtCGM routinely. | The small sample size limits transferability of the findings to the whole clinic population. - Low - |
| Burckhardt et al. (57) | rtCGM and psychosocial outcomes | 2 months prospective cohort study 65 parents and 46 children with T1D (age 15 ± 1.81 years) Some patients were treated with CSII. Device: Dexcom® G5 and Medtronic Guardian Connect. Approximately 70% of the participants were using systems with remote monitoring. Region: Western Australia |
To children over 12 years of age and their parents: HFS, PSQI, DTSQs, Gold Hypoglycemia awareness questionnaire after starting rtCGM | Total parental Hypoglycemia Fear and worry decreased, no difference in children were observed. Satisfaction regarding diabetes treatment improved both in parents and children Frequency of overnight BG testing decreased significantly. The percentage of children with reduced awareness of hypoglycemia decreased. Reported parental sleep quality improved Parents reported to miss fewer work days 11 children stopped rtCGM because of: sensor connection issues, general dislike, sensor falling off during exercise and problems with sensor change. |
The small sample size limits transferability of the findings to the whole clinic population. Moreover, rtCGM was discontinued due to technical issues and dislike of the system. - Moderate - |
| Jaser et al. (58) | Associations between rtCGM and child sleep, glycemic control and adherence, parent sleep and well-being, parental fear of hypoglycemia, and nocturnal caregiving behavior | Descriptive observational study 515 parents of 2–12-year-old participants in the T1D Exchange clinic registry. Device: rtCGM 80% used insulin pump |
Surveys were emailed to parents: CSHQ, PSQI, HFS, WHO-5 questionnaires | 67% of children met criteria for poor sleep quality. Child sleep was not related to the use of diabetes-related technology (rtCGM, insulin pump) Child sleep quality and duration was related to HbA1c but not to mean frequency of BG monitoring. Children with poor sleep quality were more likely to experience severe hypoglycemia and DKA. Poorer child sleep quality was associated with poorer parental sleep quality, parental well-being, and fear of hypoglycemia. | Use of parent-report measures of child sleep - Moderate - |
| Al Hayek et al. (59) | Effect of isCGM on glycemic control, hypoglycemia, HTQoL, and FOH | 3 months prospective study 47 youth with T1D (age 13–19 years) Device: isCGM 38% of children used CSII Region: Saudi Arabia |
At the baseline and after 3 months validated questionnaires were administered: HFS-C, PedsQL 3.0 DM. | isCGM scanning can effectively reduce fear of hypoglycemia (FOH), worry and HbA1c level. It also improves QoL. The frequency of self-testing by isCGM is 8 times greater than in BGM by finger pricking. A higher frequency of isCGM scan positively correlates with behavior and QoL Significant improvement in behavior, worry, and hypoglycemia among the CSII patients. |
Small sample size and inclusion of only one center for study. - Moderate - |
| Mauras et al. (6) | rtCGM benefit in young children aged 4–9 years with T1D | RCT, 26 weeks 146 children with T1D, 4–9 years 64% were on pumps Region: USA | Participants were “naïve” for rtCGM Parents completed at baseline and at 26 weeks: GMS, PAID, HFS, CGM-SAT The primary outcome was HbA1c |
rtCGM wear was well-tolerated, and parental satisfaction with rtCGM was high. However, parental fear of hypoglycemia was not reduced. rtCGM wear decreased over time |
- High - |
| Laffel et al. (60) | Effect of rtCGM on glycemic control and 20 secondary outcomes | RCT 153 youth with T1D (age 14–24 years), HbA1c 7.5–10.9% Device: rtCGM (Dexcom G5®) 70% of youth used CSII Region: USA |
Youth completed at the baseline and after 26 weeks: PAID, HCS, PSQI | rtCGM use gave reduction in the time spent in hyperglycemia and hypoglycemia; difference in the glucose monitoring satisfaction. No difference in diabetes problem areas, hypoglycemia confidence and sleep quality were reported. The use of rtCGM device does not increased burden. |
rtCGM used in the trial required twice-daily calibrations with BGM. - High - |
| Lawton et al. (61) | Participants' experiences using rtCGM. | Qualitative study 15 children aged <12; 13–15; >16 years HbA1c 7.5–10% 9 parents Device: Guardian™ Sensor 3, Medtronic 640G (100%) Region: United Kingdom |
Interview, after ≥4 weeks of rtCGM use, analyzed: Previous experience of using rtCGM and SMBG; understandings, expectations and impact on diabetes self-management; likes and dislikes of the technology; views about information and training needed to support effective use of rtCGM. |
Benefits deriving from the use of rtCGM: -increased awareness about glycemic values -instant and effortless access to data -prevents hypoglycemia and hyperglycemia events -short-term lifestyle changes (diet, physical activity) -better understanding of how insulin, food and physical activity impact on BG levels. -promote diabetes self-management -high treatment satisfaction Sleep quality: in some cases offered peace of mind that in target and stable BG control was being achieved and a better quality of sleep. Alarms have been identified as a factor causing decreased sleep quality and interrupted sleep. Alarm fatigue: in general individuals reported clear clinical and psychological benefits to alarms alerting. Others noted how alarms could result in distractions in the workplace or at school. Barriers: difficulty inserting and/or removing the device, finding a discreet place on the body to place it on, occasional signal loss and difficulties resulting from the need to regularly calibrate their devices (12 every hour). However, all emphasized that the clinical and psychological benefits of rtCGM outweighed any challenges encountered. |
Limited observation time; CSII population, the results may not be generalizable to those using insulin injection regimens. - Low - |
| Sinisterra et al. (62) | Sleep characteristics and nocturnal BGM (NBGM) Pediatric and parental HRQOL Relationship with RTCGM use. | Prospective study, only baseline data are presented 46 parent-child dyads (age 2–5 years). Device: rtCGM Region: USA |
Participants complete PedsQL Sleep quality was assessed with specific questions listed accelerometry devices were used to objectively measure child sleep for a subset of participants. | rtCGM use: -may be helpful for improving child sleep and QoL -may assist child sleep duration by minimizing their wake periods throughout the night, given that parents are less likely to wake their child up for NBGM. Parents of children on rtCGM reported a higher frequency of NBGM which may contribute to greater sleep disturbances. |
This study does not include a validated parent-report sleep measure. Small sample size - Moderate - |
| Diabetes Research in Children Network (DirecNet) Study Group (63) | Psychological impact of clinical use of a rtCGM | RCT, 6 months A multi-center sample of 200 youths, aged 7–17 years, with T1D and their parents 46% were on CSII Use of the GlucoWatch G2® Biographer (GW2B) as rtCGM Region: USA |
DSMP, DWS, PedsQL, CGM-SAT were administered at 0 and 6 months The DSMP was completed by telephone interview, the other on a tablet or personal computer Satisfaction with use of the GW2B was measured at end of study | Little evidence that GW2B use resulted in either beneficial or adverse psychological effects on either parents or older youths. GW2B use declined steadily during the study. Better treatment adherence (DSMP) and quality of life (PedsQL) as reported by parents at baseline was associated with more frequent GW2B use during the study. |
The study was designed with the assumption that GW2B use would be relatively stable over the 6-mo study period. This was not the case as GW2B use declined steadily during the study The present study did not systematically assess how patients and parents used and responded to GW2B data - Moderate - |
| Al Hayek et al. (64) | Treatment satisfaction and sense of well-being with isCGM | 12 weeks prospective cohort study 33 patients with T1D (age 14–21 years) 30% of children used CSII Device: isCGM Region: Saudi Arabia |
At baseline and after 12 weeks: DTSQ and WHO-5 questionnaire | At 12 weeks: improvements in treatment satisfaction and mental well-being scores were detected. Improvements in the overall Diabetes treatment satisfaction questionnaire (DTSQ) score from baseline to 12 weeks. The well-being percentage score showed a statistically significant difference in well-being (WHO-5). |
Small sample size - Moderate - |
| Pintus et al. (65) | Metabolic outcomes and QoL in children that used isCGM. | 12 months prospective observational study 52 children with T1D (age 5–18 years) Device: isCGM Region: United Kingdom |
The Peds QL 3.2 questionnaire was used to assess QoL before and 3 months after the use of the system. PedsQL parent report was used for parents. | The results demonstrated significant improvement in patient QoL, reduction of diabetes symptoms and treatment barriers. The use of isCGM associated with structured education improves QoL and glycemic control of children and their family. |
The small sample size, limited time in observing QoL (3 months), 31–42% of patients stopped using isCGM at 6 and 12 months. - Moderate - |
For each study, the analyzed “Psychological Outcome” is underlined.