Acta Diabetol (2014) 51:499–503 DOI 10.1007/s00592-013-0545-z
ORIGINAL ARTICLE
Parental sleep quality and continuous glucose monitoring system use in children with type 1 diabetes Z. Landau • M. Rachmiel • O. Pinhas-Hamiel M. Boaz • Y. Bar-Dayan • J. Wainstein • R. Tauman
•
Received: 9 November 2013 / Accepted: 7 December 2013 / Published online: 27 December 2013 Ó Springer-Verlag Italia 2013
Abstract To compare sleep quality and sleep–wake patterns in parents of children with type 1 diabetes before routine use of the continuous glucose monitoring system (CGMS) and while using it. Thirteen parents completed the Pittsburg Sleep Quality Index (PSQI), a 7-day sleep diary, and wore an actigraph (a wristwatch-size motion detector) during the night for 1 week before pediatric use of CGMS and 4–8 weeks after initiating routine use of the CGMS. Mean age of parents (ten mothers, three fathers) was 39 (range 32–47) years; mean age of children was 9.3 years (range 5.5–16.5 years); mean disease duration was 3.4 (range 0.6–11.2) years. PSQI total score demonstrated similar quality of sleep with and without use of the CGMS (4.6 and 4.9, respectively, p = 0.45). Six of the 13 parents reported severe sleep problems (PSQI C 5) with and without the CGMS. The sleep diary indicated a greater
number of awakening episodes during CGMS use than without the CGMS (1.6 and 1, respectively, p = 0.03), and actigraphy documented an increase in the number of wake bouts (22.9 and 19.7, p = 0.03) as well as in total wake time (48.3 and 42.2 min, p = 0.03) during CGMS use as compared with the period prior to CGMS use. Although self-perception of sleep quality remained unchanged, CGMS use appeared to affect actual parental sleep continuity somewhat negatively. This should be made clear to parents who may hold expectations of improvement in sleep quality following initiation of CGMS use. Keywords Pediatric type 1 diabetes PSQI Actigraphy CGM Sleep disturbance
Introduction Communicated by Antonio Secchi. Z. Landau and M. Rachmiel have contributed equally to this work. Z. Landau (&) Pediatric Endocrine and Diabetes Service, E. Wolfson Medical Center, Holon 58100, Israel e-mail: [email protected] Z. Landau M. Rachmiel O. Pinhas-Hamiel Y. Bar-Dayan J. Wainstein R. Tauman Sackler School of Medicine, Tel Aviv University, Tel Aviv 69978, Israel
Parenting a child with type 1 diabetes (T1D) is challenging. In addition to the usual aims of promoting physical, M. Boaz Epidemiology and Research Unit, E. Wolfson Medical Center, Holon 58100, Israel Y. Bar-Dayan J. Wainstein Diabetes Unit, Wolfson Medical Center, Holon, Israel R. Tauman Sleep Disorders Center, Dana Children’s Hospital, Tel Aviv Medical Center, Tel Aviv 64239, Israel
M. Rachmiel Department of Pediatrics, Assaf Harofeh Medical Center, Zerifin, Israel O. Pinhas-Hamiel Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children’s Hospital, Sheba Medical Center, Ramat Gan 52621, Israel
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cognitive, and socioemotional growth and development, parents must face the complex management of the disease, including blood glucose monitoring, insulin administration, and meal planning [1]. Caring for a child with T1D entails significant investment of time and energy not only during the day but also during the night, resulting in sleep disruption and chronic partial sleep deprivation [2]. Particularly, onerous is the fear of hypoglycemia, especially during the night [3]. Parents reported alterations in sleeping arrangements following diagnosis of T1D (e.g., increased child co-sleeping with parents), as well as increased sleep deprivation due to multiple night wakings to check on the child [2, 4]. Parents may become so overburdened with concerns related to the day-to-day illness management, especially prevention of hypoglycemia, that they lose sight of normal development and psychosocial interaction, as well as other family-related needs. There is a documented link between parental sleep quality and daytime functioning [5]. Therefore, it is critical to understand the day-to-day experiences of parents to be able to provide appropriate guidance and support. Recently, devices for real-time continuous glucose monitoring have been introduced to aid self-management of glycemic control. These devices provide a means for continual observation of the interstitial glucose levels, including trends of decrement and increment, as well as for the activation of an alarm to warn of either impending hypoglycemia or high glucose levels. In Israel, the CGMS was approved for routine usage in the pediatric population (0–18 years) in 2011, particularly for those with recurrent hypoglycemic episodes. As family-centered care has become the standard of practice in many pediatric medical communities, especially in multi-disciplinary diabetes clinics, parental well-being has become an important component in managing a child with T1D. Parental sleep is an essential element and a potential target for intervention [6]. It was hypothesized that the use of CGMS might well reduce parental anxiety and improve the quality of sleep. The purpose of the current study was to compare objective and subjective sleep quality and sleep–wake patterns of parents of children with T1D before and during routine use of CGMS. It was felt that an understanding of the effect of CGMS use on parental sleep might help health care providers offer more precise management guidance for parents of children with T1D.
Methods Subjects In this observational prospective study, parents of children with T1D younger than 17 years who had considered
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routine use of CGMS were recruited at three T1D clinics in Israel (the E. Wolfson Medical Center, the Assaf Harofe Medical Center, and the Edmond and Lily Safra Children’s Hospital) between May 2011 and May 2012. Data were collected during the period of 1 week prior to CGMS use (pre-CGMS session) and during 1 week following initiation of CGMS use (post-CGMS session). To ensure adjustment to the CGMS, the post-CGMS session was conducted at least 4 weeks after the initiation of routine CGMS use. Parents of children with siblings younger than 2 years of age or with siblings with T1D and parents with any known sleep disorders were excluded from the study. On recruitment, we asked each family to identify the primary nighttime caregiver. Informed consent was obtained from each participant during a routine visit in the diabetes clinic. The institutional review board approved the study. Measures Pittsburgh Sleep Quality Index (PSQI) The PSQI is a well validated 19-item self-report instrument that measures sleep disturbances in adults [7]. The PSQI provides a global score ranging from no sleep difficulty to severe difficulties and includes seven subscale scores (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications, and daytime dysfunction). In addition to sleep continuity variables, the PSQI inquires about the frequency of different reasons for sleep disruption. Individuals with total PSQI scores of C5 were identified as having severe sleep problems [7]. The PSQI has demonstrated good validity and reliability [8]. The questionnaire has been translated into 48 languages, including Hebrew [9]. Each participant completed the PSQI prior to use of the CGMS and 4–8 weeks thereafter. Actigraphy Actigraphy was conducted for each participant for seven consecutive nights prior to CGMS use and for the seven consecutive nights of the post-CGMS session conducted 4–8 weeks thereafter. An actigraph is a motion detector, the size of a wrist-watch (Actiwatch AW-64, Minimitter Respironics OR, USA) that has been shown to be highly valid and reliable for differentiation of sleep from wakefulness, as well as for recording total sleep time [10, 11]. The actigraph was worn on the non-dominant wrist. Sleep patterns were analyzed using the validated Sadeh scoring algorithm developed for adults and adolescents [12]. Actigraphic sleep measures included the following: (a) sleep onset/bedtime; (b) sleep offset/wake time, (c) total sleep time, (d) number of nighttime waking/wake bouts, (e) sleep onset latency, (f) sleep efficiency (actual sleep time divided
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by time in bed, expressed as a percent), and (g) fragmentation index (a measure of restlessness during sleep). The activity data retrieved from the actigraph were downloaded using the automatic actigraph interface unit.
The sleep diary
Table 1 Demographic variables for parents and children (n = 13), including range for relevant items
Statistical analysis
Characteristics of subjects
Data were stored on a spreadsheet and analyzed on SPSS v21 (IBM Inc., USA). Distributions of continuous variables were assessed for normality using the Kolmogorov–Smirnov test (cutoff at p \ 0.01). Continuous variables are presented as mean ± SD. Continuous variables were compared before versus after introduction of CGMS using the paired t test or the Wilcoxon signed ranks test as appropriate. Categorical variables were assessed using frequency tables and are presented as n (%). Categorical variables were compared before versus after introduction of CGMS using the McNemar test. All tests are two sided and considered significant at p \ 0.05.
Parents’ age, years (mean, range)
39 (32–47)
Parents’ marital status Married, number (%)
11(85 %)
Nighttime caregiver’s gender F:M
10:3
Child’s age at diagnosis, years (mean, range)
5.9 (2–9.5)
Child’s current age, years (mean, range)
9.3 (5.5–16.5)
Child’s gender F:M Time interval from diagnosis of T1DM, years (mean, range)
4:9 3.4 (0.6–11.2)
Child’s HbA1c at baseline, % (mean, range)
7.5 (6.3–8.9)
Table 2 Sleep measures derived from PSQI, sleep log, and actigraph
Each participant completed a sleep diary for the seven consecutive nights; during the period of time, the actigraph was worn.
Characteristics
Pre-CGM mean (range)
With CGM mean (range)
p value
Sleep duration (h) [Q1]
1
1.08
0.74
Sleep disturbances [Q2] Sleep latency [Q3]
1.08 0.77
1.0 0.46
0.32 0.10
PSQI
Daytime functioning [Q4]
0.69
0.62
0.73
Sleep efficiency [Q5]
0.31
0.46
0.41
Sleep quality [Q6]
1.08
1
0.66
Sleeping aid medications [Q7]
0
0
1
PSQI total [Q8]
4.9 (2–11)
4.6 (1–7)
0.46
Sleep latency (min)
16 (0–22.9)
18 (0–38.2)
0.87
Awakenings (no.)
1 (0–2.3)
1.6 (0.6–2.8)
0.009
Reporting fully awake in the morning (%)
17 (0–50)
38.5 (0–100)
0.21
Reporting being tired in the morning (%)
29 (0–86)
25.5 (0–100)
0.45
Sleep duration (h)
6.4 (5–7.5)
6.4 (4.8–8.5)
0.35
Days with awakenings due to diabetes (%)
63 (0–100)
59.2 (0–100)
0.96
Sleep diary
Actigraph
Possible range for PSQI subscales is 0–3 for each scale, with possible range for total score 0–21. Higher scores for all scales represent poorer sleep
Actual sleep time (h)
6:36 (4:30–14:00)
6:12 (4:31–8:06)
0.81
Sleep efficiency (%) Sleep latency (min)
85.1 (79.2–91.4) 11 (4–24)
84.7 (78.1–92.4) 11 (1–24)
0.39 0.272
Awake bouts (no.)
19.7 (12.0–26.8)
22.9 (15.0–34.1)
0.038
Mean wake bout time (min)
02:07 (01:21–02:43)
02:00 (01:25–02:39)
0.337
Total wake time (min)
42.4 (22.2–71.0)
48.3 (24.7–67.8)
0.039
Wake-up percent (%)
10.7 (5.5–14.8)
11.7 (5.8–17.6)
0.133
Fragmentation index
25.7 (15.2–42.1)
24.6 (12.7–39.6)
0.10
123
502
Results Twenty parents completed the study requirement for the pre-CGMS session. Of these, 13 completed the study protocol for the post-CGMS session as well. Only the data of the latter are presented in this report. Subject’s characteristics are summarized in Table 1. All the T1D children were being treated with an insulin pump. None of the parents used sleep medications during the study period. The CGMS was used on all the nights during the second part of the study. Comparisons of sleep measures pre- and post-CGMS sessions are presented in Table 2. No episodes of severe hypoglycemia or diabetic ketoacidosis occurred during either of these periods in any of the children. PSQI No differences were demonstrated between preand post-CGMS sessions in any of the PSQI scores as well as the total PSQI score (Table 1). PSQI score C5 was documented in 6/13 parents pre- and post-CGMS sessions. The Sleep Diary Significantly, more wakening episodes were reported by the parents in the post-CGMS session (1.0 vs. 1.6 times per night for pre- and post-CGMS sessions, respectively, p \ 0.003). No other differences in sleep diary measures were found (Table 2). Seventy-seven percent of parental nocturnal awakenings were due to diabetes’ care in both pre- and post-CGMS sessions. Actigraphy The number of wake bouts recorded during the post-CGMS session was greater than that of the pre-CGMS session (22.9 vs. 19.7 wake bouts per night, respectively, p \ 0.003). Total wake time per night was longer during the post-CGMS session than during the pre-CGMS session (48.3. vs. 42.4 min, respectively, p \ 0.003).
Discussion This observational prospective study is the first to use validated measures for determining objective and subjective sleep quality and sleep–wake patterns in parents of children with T1D before and during use of the CGMS as part of their clinical care. Our results showed that almost half of the parents of children with T1D had poor sleep quality (PSQI C5) both with and without the CGMS. Moreover, use of the CGMS did not change the subjective perception of parental sleep quality as expressed by the PSQI. CGMS use was associated with an increase in the number of nocturnal awakenings, as documented in the sleep diary and by actigraphy. Finally, total wake time was increased with the use of CGMS, as shown by actigraphy. The rationale for integrating CGMS in diabetes management is improvement to diabetes control while lowering the risk of hypoglycemic episodes. We hypothesized that use of the CGMS would be associated with improved
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parental quality of sleep, indicated by parents to be a desired advantage of this device. Since quality of sleep is correlated with general health, quality of life, and decreasing morbidity and mortality [13], this aspect should be a target for investigation and intervention. Our results indicate that CGMS use does not improve parental sleep quality and may even have negative effect on parental sleep continuity. There are several possible explanations for the increased parental nocturnal awakenings and longer total wake time while using the CGMS found in our study. It is possible that the introduction of the CGMS in itself increases parental anxiety and that parents woke up more often to check the device accuracy. It is also possible that parental adjustment to the new device is longer than the time interval of 4–8 weeks between the preand post-CGMS sessions. Our finding that almost 50 % of parents had poor sleep quality supports previous reports [2, 4] and emphasizes the need for focusing on this aspect of quality of life in families of children with T1D. In conclusion, CGMS use would appear to have a negative effect on parental sleep continuity, although selfperception of sleep quality remains unchanged. Assisting parents to maintain realistic expectations regarding a possible improvement in quality of sleep with CGMS use is warranted. Acknowledgments We gratefully acknowledge the time and energy contributed by all parents during the progress of this study. Conflict of interest
None.
Human and Animal Rights disclosure All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent disclosure Informed consent was obtained from all patients for being included in the study.
References 1. Canam C (1993) Common adaptive tasks facing parents of children with chronic conditions. J Adv Nurs 18(1):46–53 2. Sullivan-Bolyai S, Deatrick J, Gruppuso P, Tamborlane W, Grey M (2003) Constant vigilance: mothers’ work parenting young children with type 1 diabetes. J Pediatr Nurs 18(1):21–29 3. Barnard K, Thomas S, Royle P, Noyes K, Waugh N (2010) Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr 10:50 4. Monaghan MC, Hilliard ME, Cogen FR, Streisand R (2009) Nighttime caregiving behaviors among parents of young children with Type 1 diabetes: associations with illness characteristics and parent functioning. Fam Syst Health 27(1):28–38 5. Meltzer LJ, Moore M (2008) Sleep disruptions in parents of children and adolescents with chronic illnesses: prevalence, causes, and consequences. J Pediatr Psychol 33(3):279–291
Acta Diabetol (2014) 51:499–503 6. Estrada CL, Danielson KK, Drum ML, Lipton RB (2011) Insufficient sleep in young patients with diabetes and their families. Biol Res Nurs 7. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ (1989) The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 28(2):193–213 8. Carpenter JS, Andrykowski MA (1998) Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res 45(1):5–13 9. Shochat T, Tzischinsky O, Oksenberg A, Peled R (2007) Validation of the Pittsburgh Sleep Quality Index Hebrew translation (PSQI-H) in a sleep clinic sample. Isr Med Assoc J 9(12): 853–856
503 10. Jean-Louis G, von Gizycki H, Zizi F, Fookson J, Spielman A, Nunes J, Fullilove R, Taub H (1996) Determination of sleep and wakefulness with the actigraph data analysis software (ADAS). Sleep 19(9):739–743 11. Sadeh A, Acebo C (2002) The role of actigraphy in sleep medicine. Sleep Med Rev 6(2):113–124 12. Sadeh A, Sharkey KM, Carskadon MA (1994) Activity-based sleep–wake identification: an empirical test of methodological issues. Sleep 17(3):201–207 13. Buysse DJ, Grunstein R, Horne J, Lavie P (2010) Can an improvement in sleep positively impact on health? Sleep Med Rev 14(6):405–410
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ORIGINAL ARTICLE
Parental sleep quality and continuous glucose monitoring system use in children with type 1 diabetes Z. Landau • M. Rachmiel • O. Pinhas-Hamiel M. Boaz • Y. Bar-Dayan • J. Wainstein • R. Tauman
•
Received: 9 November 2013 / Accepted: 7 December 2013 / Published online: 27 December 2013 Ó Springer-Verlag Italia 2013
Abstract To compare sleep quality and sleep–wake patterns in parents of children with type 1 diabetes before routine use of the continuous glucose monitoring system (CGMS) and while using it. Thirteen parents completed the Pittsburg Sleep Quality Index (PSQI), a 7-day sleep diary, and wore an actigraph (a wristwatch-size motion detector) during the night for 1 week before pediatric use of CGMS and 4–8 weeks after initiating routine use of the CGMS. Mean age of parents (ten mothers, three fathers) was 39 (range 32–47) years; mean age of children was 9.3 years (range 5.5–16.5 years); mean disease duration was 3.4 (range 0.6–11.2) years. PSQI total score demonstrated similar quality of sleep with and without use of the CGMS (4.6 and 4.9, respectively, p = 0.45). Six of the 13 parents reported severe sleep problems (PSQI C 5) with and without the CGMS. The sleep diary indicated a greater
number of awakening episodes during CGMS use than without the CGMS (1.6 and 1, respectively, p = 0.03), and actigraphy documented an increase in the number of wake bouts (22.9 and 19.7, p = 0.03) as well as in total wake time (48.3 and 42.2 min, p = 0.03) during CGMS use as compared with the period prior to CGMS use. Although self-perception of sleep quality remained unchanged, CGMS use appeared to affect actual parental sleep continuity somewhat negatively. This should be made clear to parents who may hold expectations of improvement in sleep quality following initiation of CGMS use. Keywords Pediatric type 1 diabetes PSQI Actigraphy CGM Sleep disturbance
Introduction Communicated by Antonio Secchi. Z. Landau and M. Rachmiel have contributed equally to this work. Z. Landau (&) Pediatric Endocrine and Diabetes Service, E. Wolfson Medical Center, Holon 58100, Israel e-mail: [email protected] Z. Landau M. Rachmiel O. Pinhas-Hamiel Y. Bar-Dayan J. Wainstein R. Tauman Sackler School of Medicine, Tel Aviv University, Tel Aviv 69978, Israel
Parenting a child with type 1 diabetes (T1D) is challenging. In addition to the usual aims of promoting physical, M. Boaz Epidemiology and Research Unit, E. Wolfson Medical Center, Holon 58100, Israel Y. Bar-Dayan J. Wainstein Diabetes Unit, Wolfson Medical Center, Holon, Israel R. Tauman Sleep Disorders Center, Dana Children’s Hospital, Tel Aviv Medical Center, Tel Aviv 64239, Israel
M. Rachmiel Department of Pediatrics, Assaf Harofeh Medical Center, Zerifin, Israel O. Pinhas-Hamiel Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children’s Hospital, Sheba Medical Center, Ramat Gan 52621, Israel
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500
cognitive, and socioemotional growth and development, parents must face the complex management of the disease, including blood glucose monitoring, insulin administration, and meal planning [1]. Caring for a child with T1D entails significant investment of time and energy not only during the day but also during the night, resulting in sleep disruption and chronic partial sleep deprivation [2]. Particularly, onerous is the fear of hypoglycemia, especially during the night [3]. Parents reported alterations in sleeping arrangements following diagnosis of T1D (e.g., increased child co-sleeping with parents), as well as increased sleep deprivation due to multiple night wakings to check on the child [2, 4]. Parents may become so overburdened with concerns related to the day-to-day illness management, especially prevention of hypoglycemia, that they lose sight of normal development and psychosocial interaction, as well as other family-related needs. There is a documented link between parental sleep quality and daytime functioning [5]. Therefore, it is critical to understand the day-to-day experiences of parents to be able to provide appropriate guidance and support. Recently, devices for real-time continuous glucose monitoring have been introduced to aid self-management of glycemic control. These devices provide a means for continual observation of the interstitial glucose levels, including trends of decrement and increment, as well as for the activation of an alarm to warn of either impending hypoglycemia or high glucose levels. In Israel, the CGMS was approved for routine usage in the pediatric population (0–18 years) in 2011, particularly for those with recurrent hypoglycemic episodes. As family-centered care has become the standard of practice in many pediatric medical communities, especially in multi-disciplinary diabetes clinics, parental well-being has become an important component in managing a child with T1D. Parental sleep is an essential element and a potential target for intervention [6]. It was hypothesized that the use of CGMS might well reduce parental anxiety and improve the quality of sleep. The purpose of the current study was to compare objective and subjective sleep quality and sleep–wake patterns of parents of children with T1D before and during routine use of CGMS. It was felt that an understanding of the effect of CGMS use on parental sleep might help health care providers offer more precise management guidance for parents of children with T1D.
Methods Subjects In this observational prospective study, parents of children with T1D younger than 17 years who had considered
123
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routine use of CGMS were recruited at three T1D clinics in Israel (the E. Wolfson Medical Center, the Assaf Harofe Medical Center, and the Edmond and Lily Safra Children’s Hospital) between May 2011 and May 2012. Data were collected during the period of 1 week prior to CGMS use (pre-CGMS session) and during 1 week following initiation of CGMS use (post-CGMS session). To ensure adjustment to the CGMS, the post-CGMS session was conducted at least 4 weeks after the initiation of routine CGMS use. Parents of children with siblings younger than 2 years of age or with siblings with T1D and parents with any known sleep disorders were excluded from the study. On recruitment, we asked each family to identify the primary nighttime caregiver. Informed consent was obtained from each participant during a routine visit in the diabetes clinic. The institutional review board approved the study. Measures Pittsburgh Sleep Quality Index (PSQI) The PSQI is a well validated 19-item self-report instrument that measures sleep disturbances in adults [7]. The PSQI provides a global score ranging from no sleep difficulty to severe difficulties and includes seven subscale scores (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications, and daytime dysfunction). In addition to sleep continuity variables, the PSQI inquires about the frequency of different reasons for sleep disruption. Individuals with total PSQI scores of C5 were identified as having severe sleep problems [7]. The PSQI has demonstrated good validity and reliability [8]. The questionnaire has been translated into 48 languages, including Hebrew [9]. Each participant completed the PSQI prior to use of the CGMS and 4–8 weeks thereafter. Actigraphy Actigraphy was conducted for each participant for seven consecutive nights prior to CGMS use and for the seven consecutive nights of the post-CGMS session conducted 4–8 weeks thereafter. An actigraph is a motion detector, the size of a wrist-watch (Actiwatch AW-64, Minimitter Respironics OR, USA) that has been shown to be highly valid and reliable for differentiation of sleep from wakefulness, as well as for recording total sleep time [10, 11]. The actigraph was worn on the non-dominant wrist. Sleep patterns were analyzed using the validated Sadeh scoring algorithm developed for adults and adolescents [12]. Actigraphic sleep measures included the following: (a) sleep onset/bedtime; (b) sleep offset/wake time, (c) total sleep time, (d) number of nighttime waking/wake bouts, (e) sleep onset latency, (f) sleep efficiency (actual sleep time divided
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by time in bed, expressed as a percent), and (g) fragmentation index (a measure of restlessness during sleep). The activity data retrieved from the actigraph were downloaded using the automatic actigraph interface unit.
The sleep diary
Table 1 Demographic variables for parents and children (n = 13), including range for relevant items
Statistical analysis
Characteristics of subjects
Data were stored on a spreadsheet and analyzed on SPSS v21 (IBM Inc., USA). Distributions of continuous variables were assessed for normality using the Kolmogorov–Smirnov test (cutoff at p \ 0.01). Continuous variables are presented as mean ± SD. Continuous variables were compared before versus after introduction of CGMS using the paired t test or the Wilcoxon signed ranks test as appropriate. Categorical variables were assessed using frequency tables and are presented as n (%). Categorical variables were compared before versus after introduction of CGMS using the McNemar test. All tests are two sided and considered significant at p \ 0.05.
Parents’ age, years (mean, range)
39 (32–47)
Parents’ marital status Married, number (%)
11(85 %)
Nighttime caregiver’s gender F:M
10:3
Child’s age at diagnosis, years (mean, range)
5.9 (2–9.5)
Child’s current age, years (mean, range)
9.3 (5.5–16.5)
Child’s gender F:M Time interval from diagnosis of T1DM, years (mean, range)
4:9 3.4 (0.6–11.2)
Child’s HbA1c at baseline, % (mean, range)
7.5 (6.3–8.9)
Table 2 Sleep measures derived from PSQI, sleep log, and actigraph
Each participant completed a sleep diary for the seven consecutive nights; during the period of time, the actigraph was worn.
Characteristics
Pre-CGM mean (range)
With CGM mean (range)
p value
Sleep duration (h) [Q1]
1
1.08
0.74
Sleep disturbances [Q2] Sleep latency [Q3]
1.08 0.77
1.0 0.46
0.32 0.10
PSQI
Daytime functioning [Q4]
0.69
0.62
0.73
Sleep efficiency [Q5]
0.31
0.46
0.41
Sleep quality [Q6]
1.08
1
0.66
Sleeping aid medications [Q7]
0
0
1
PSQI total [Q8]
4.9 (2–11)
4.6 (1–7)
0.46
Sleep latency (min)
16 (0–22.9)
18 (0–38.2)
0.87
Awakenings (no.)
1 (0–2.3)
1.6 (0.6–2.8)
0.009
Reporting fully awake in the morning (%)
17 (0–50)
38.5 (0–100)
0.21
Reporting being tired in the morning (%)
29 (0–86)
25.5 (0–100)
0.45
Sleep duration (h)
6.4 (5–7.5)
6.4 (4.8–8.5)
0.35
Days with awakenings due to diabetes (%)
63 (0–100)
59.2 (0–100)
0.96
Sleep diary
Actigraph
Possible range for PSQI subscales is 0–3 for each scale, with possible range for total score 0–21. Higher scores for all scales represent poorer sleep
Actual sleep time (h)
6:36 (4:30–14:00)
6:12 (4:31–8:06)
0.81
Sleep efficiency (%) Sleep latency (min)
85.1 (79.2–91.4) 11 (4–24)
84.7 (78.1–92.4) 11 (1–24)
0.39 0.272
Awake bouts (no.)
19.7 (12.0–26.8)
22.9 (15.0–34.1)
0.038
Mean wake bout time (min)
02:07 (01:21–02:43)
02:00 (01:25–02:39)
0.337
Total wake time (min)
42.4 (22.2–71.0)
48.3 (24.7–67.8)
0.039
Wake-up percent (%)
10.7 (5.5–14.8)
11.7 (5.8–17.6)
0.133
Fragmentation index
25.7 (15.2–42.1)
24.6 (12.7–39.6)
0.10
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Results Twenty parents completed the study requirement for the pre-CGMS session. Of these, 13 completed the study protocol for the post-CGMS session as well. Only the data of the latter are presented in this report. Subject’s characteristics are summarized in Table 1. All the T1D children were being treated with an insulin pump. None of the parents used sleep medications during the study period. The CGMS was used on all the nights during the second part of the study. Comparisons of sleep measures pre- and post-CGMS sessions are presented in Table 2. No episodes of severe hypoglycemia or diabetic ketoacidosis occurred during either of these periods in any of the children. PSQI No differences were demonstrated between preand post-CGMS sessions in any of the PSQI scores as well as the total PSQI score (Table 1). PSQI score C5 was documented in 6/13 parents pre- and post-CGMS sessions. The Sleep Diary Significantly, more wakening episodes were reported by the parents in the post-CGMS session (1.0 vs. 1.6 times per night for pre- and post-CGMS sessions, respectively, p \ 0.003). No other differences in sleep diary measures were found (Table 2). Seventy-seven percent of parental nocturnal awakenings were due to diabetes’ care in both pre- and post-CGMS sessions. Actigraphy The number of wake bouts recorded during the post-CGMS session was greater than that of the pre-CGMS session (22.9 vs. 19.7 wake bouts per night, respectively, p \ 0.003). Total wake time per night was longer during the post-CGMS session than during the pre-CGMS session (48.3. vs. 42.4 min, respectively, p \ 0.003).
Discussion This observational prospective study is the first to use validated measures for determining objective and subjective sleep quality and sleep–wake patterns in parents of children with T1D before and during use of the CGMS as part of their clinical care. Our results showed that almost half of the parents of children with T1D had poor sleep quality (PSQI C5) both with and without the CGMS. Moreover, use of the CGMS did not change the subjective perception of parental sleep quality as expressed by the PSQI. CGMS use was associated with an increase in the number of nocturnal awakenings, as documented in the sleep diary and by actigraphy. Finally, total wake time was increased with the use of CGMS, as shown by actigraphy. The rationale for integrating CGMS in diabetes management is improvement to diabetes control while lowering the risk of hypoglycemic episodes. We hypothesized that use of the CGMS would be associated with improved
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parental quality of sleep, indicated by parents to be a desired advantage of this device. Since quality of sleep is correlated with general health, quality of life, and decreasing morbidity and mortality [13], this aspect should be a target for investigation and intervention. Our results indicate that CGMS use does not improve parental sleep quality and may even have negative effect on parental sleep continuity. There are several possible explanations for the increased parental nocturnal awakenings and longer total wake time while using the CGMS found in our study. It is possible that the introduction of the CGMS in itself increases parental anxiety and that parents woke up more often to check the device accuracy. It is also possible that parental adjustment to the new device is longer than the time interval of 4–8 weeks between the preand post-CGMS sessions. Our finding that almost 50 % of parents had poor sleep quality supports previous reports [2, 4] and emphasizes the need for focusing on this aspect of quality of life in families of children with T1D. In conclusion, CGMS use would appear to have a negative effect on parental sleep continuity, although selfperception of sleep quality remains unchanged. Assisting parents to maintain realistic expectations regarding a possible improvement in quality of sleep with CGMS use is warranted. Acknowledgments We gratefully acknowledge the time and energy contributed by all parents during the progress of this study. Conflict of interest
None.
Human and Animal Rights disclosure All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent disclosure Informed consent was obtained from all patients for being included in the study.
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