Schooling diabetes: Use of continuous glucose monitoring and remote monitors in the home and school settings.
ABSTRACT: BACKGROUND:Despite significant advances in type 1 diabetes (T1D) management, achieving targeted glycemic control in pediatric patients remains a struggle. Continuous glucose monitoring (CGM) with remote access holds the promise to address this challenge by allowing caregivers to monitor glucose, even when the child is not directly under their supervision. OBJECTIVE:To explore real-time and remote CGM practices in homes and schools, including caregiver expectations regarding this technology. SUBJECTS:Parents and daytime caregivers. METHODS:Respondents answered an anonymous survey assessing characteristics of CGM use. Cross-sectional data were collected and analyzed using quantitative and qualitative methods. RESULTS:Thirty-three parents and 17 daytime caregivers responded. Threshold alerts (alerts when patients reached certain pre-set high or low limits) were used most frequently, followed by rate of change alerts. Most parents and daytime caregivers responded to low- and high-threshold CGM alerts by confirming with a glucose meter prior to treatment; while about one-third endorsed treating lows without a confirmatory test. Most parents expected their child's daytime caregiver to respond to CGM alerts and daytime caregivers felt the parent's expectations of them were reasonable. All parents and most caregivers reported decreased overall worry/stress. Parents felt positive about CGM use and daytime caregivers felt comfortable with CGM. CONCLUSION:The positive and collaborative management reported by parents and daytime caregivers sets the stage for CGM to play an important role in the management of children with T1D both in the home and in the school settings.
Project description:Background: Continuous glucose monitoring (CGM) has potential to address challenges of type 1 diabetes (T1D) management for young children. CGM use is increasing, yet remains underutilized. Characterizing parents' experiences with CGM can inform clinical strategies to help parents make decisions about diabetes management, overcome obstacles to initiating and sustaining CGM use, and maximize benefits of CGM use in their children's diabetes care. Methods: Transcripts from semistructured qualitative interviews with 55 parents of children aged 1 to <8 years, with T1D duration ?6 months, and whose child currently or previously used CGM were coded and analyzed to derive themes about their experiences with CGM. Results: Participants were 88% mothers and the mean child age was 5.0?±?1.5 years. Parents described benefits of CGM use: decreased worry about glucose excursions, improved sleep, increased sense of safety with children who cannot recognize or express symptoms of hypo- or hyperglycemia, and greater comfort with other caregivers, especially using remote monitoring functionality when away from children. Challenges included painful insertions, wearing multiple devices on small bodies, disruptive alerts, data gaps due to lost signals, skin/adhesive problems, and difficulty interpreting the amount of information generated by CGM. For some, the challenges outweighed potential benefits and they stopped CGM use. Conclusions: CGM may address unique challenges of T1D in young children and increase parental comfort with diabetes management, yet there are multiple barriers to initiating or maintaining CGM use. Education and behavioral support to address these benefits and barriers may equip caregivers with skills to address challenges of CGM use.
Project description:BACKGROUND:Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. OBJECTIVE:The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. METHODS:We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. RESULTS:Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. CONCLUSIONS:If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. TRIAL REGISTRATION:ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/17877.
Project description:BACKGROUND:In attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life. Augmenting an insulin pump with glucose sensor information leads to improved outcomes: decreased haemoglobin A1c levels, increased time in glucose target and less hypoglycaemia. Fear of nocturnal hypoglycaemia remains pervasive amongst parents, leading to chronic sleep interruption and lack of sleep for the parents and their children. The QUEST study, an open-label, single-centre randomized crossover study, aims to evaluate the impact on time in target, in hypoglycaemia and hyperglycaemia and the effect on sleep and quality of life in children with T1D, comparing a sensor-augmented pump (SAP) with predictive low glucose suspend and alerts to the use of the same insulin pump with a flash glucose measurement (FGM) device not interacting with the pump. METHODS/DESIGN:Subjects meeting the inclusion criteria are randomized to treatment with the SAP or treatment with an insulin pump and independent FGM for 5 weeks. Following a 3-week washout period, the subjects cross over to the other study arm for 5 weeks. During the week before and in the last week of treatment, the subjects and one of their caregivers wear a sleep monitor in order to obtain sleep data. The primary endpoint is the between-arm difference in percentage of time in glucose target during the final 6 days of each treatment arm, measured by a blinded continuous glucose measurement (CGM). Additional endpoints include comparison of quantity and quality of sleep as well as quality of life perception of the subjects and one of their caregivers in the two different treatment arms. Recruitment started in February 2017. A total of 36 patients are planned to be randomized. The study recruitment was completed in April 2018. DISCUSSION:With this study we will provide more information on whether insulin pump treatment combined with more technology (SmartGuard® feature and alerts) leads to better metabolic control. The inclusion of indicators on quality of sleep with less sleep interruption, less lack of sleep and perception of quality of life in both children and their primary caregivers is essential for this study and might help to guide us to further treatment improvement. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03103867 . Registered on 6 April 2017.
Project description:BACKGROUND:Managing type 1 diabetes (T1D) in young children presents challenges to families and caregivers. Pump therapy may reduce challenges and benefit glycemic control. However, pump use is not universal; parent-reported reasons for lack of uptake are not well described. METHODS:Parents of children <7, with T1D for ≥1 year, in the T1D Exchange registry completed surveys capturing demographic and clinical characteristics, as well as barriers to pump use. Data from pump users were compared to nonusers, and barriers were analyzed among parents who received pump recommendations, but decided against uptake. RESULTS:Young children (N = 515) from 41 sites were identified (mean age 5.2 ± 1.2 years, diabetes duration 2.4 ± 1.0 years, 46% female, and 78% Non-Hispanic White). Overall glycemic control was suboptimal (HbA1c 8.1% ± 1.0%). The majority were pump users (64%, n = 331; nonusers 36%, n = 184). Pump users had longer T1D duration (2.5 ± 1.1 years vs. 2.2 ± 1.0 years, P = 0.001), were more likely to have annual household incomes ≥$75,000 (62% vs. 36%, P < 0.001), have a parent with college education or higher (70% vs. 45%, P < 0.001), perform more frequent blood glucose monitoring (7.5 ± 2.5 times/day vs. 6.5 ± 2.3 times/day, P < 0.001), and use continuous glucose monitoring (CGM) (45% vs. 13%, P < 0.001). Only income, education, frequency of blood glucose monitoring, and CGM use remained significant in a multivariate model including age, sex, ethnicity, and duration of diabetes. Barriers to pump uptake included concerns with physical interference, therapeutic effectiveness, and to a lesser extent, financial burden. CONCLUSIONS:These findings provide an opportunity to address potentially modifiable parent-reported barriers to pump uptake through education and behavioral intervention.
Project description:Objective: To test whether the addition of an insulin pump or continuous glucose monitor (CGM) related to reduced glycated hemoglobin A1c (HbA1c) in large cohort of children, 5-9 years old, and within 1 year of their type 1 diabetes (T1D) diagnosis. Research Design and Methods: The study uses data from families of children with recent-onset T1D and who were between 5 and 9 years old. Study analyses used children's HbA1c values at baseline and at the 6-month follow-up. Parents reported on family demographics and children's T1D device use in their daily management (e.g., insulin pump or CGM). Children's mean T1D duration was 4.70?±?3.28 months at baseline, so the 6-month assessment point was ?12 months postdiagnosis. Results: One hundred-eleven families participated. At baseline, child mean age was 7.51?±?1.37 years, and mean child HbA1c was 7.65%?±?1.40%. In addition, 17% of children used an insulin pump, and 17.1% of children used CGM. Six months later, 35.1% of children had started an insulin pump and 25.2% had started CGM. Repeated measures analyses of variance results showed a smaller overall HbA1c between baseline and 6 months for children using an insulin pump versus children not on a pump. For CGM, results showed that children starting a CGM during this window had a significantly lower HbA1c level than children who had not started on CGM. Conclusions: The study results suggest that early initiation of either an insulin pump or CGM in children newly diagnosed with T1D may help to improve child HbA1c levels within the first 12 months of diabetes.
Project description:Objective: Impaired awareness of hypoglycemia (IAH) is a risk factor for severe hypoglycemia in patients with type 1 diabetes (T1D) not using a continuous glucose monitoring (CGM) system. The current study investigated the prevalence of IAH and its relationship with severe hypoglycemia in T1D patients using CGM systems. Methods: This cross-sectional observational study enrolled 135 patients with T1D and ongoing real-time CGM use. A survey was conducted to assess hypoglycemia awareness with the Gold, Clarke, and Pedersen-Bjergaard questionnaires and the 6-month history of severe hypoglycemia. Other diabetes histories and the CGM glucose data were collected. Results: The Gold, Clarke, and Pedersen-Bjergaard questionnaires demonstrated the overall prevalence of IAH/abnormal awareness to be 33.3%, 43.7%, and 77.0%, respectively. Participant age and duration of T1D were consistently related to IAH or hypoglycemia unawareness with all three questionnaires (P<.05). Amongst the patients using CGM for >6 months, 24.5% were found to have at least one episode of severe hypoglycemia in the preceding 6 months. IAH identified by the Gold and Clarke questionnaires and hypoglycemia unawareness identified by the Pedersen-Bjergaard questionnaire were related to 6-, 4.63-, and 5.83-fold increased risk of severe hypoglycemia (P = .001, .004, and .013), respectively. IAH identified by the Gold/Clarke questionnaires was associated with a longer duration of CGM glucose <54 mg/dL and higher glucose coefficients of variation (P<.05). Conclusion: IAH is highly prevalent and related to a higher risk for severe hypoglycemia in T1D patients using CGM. Abbreviations: CGM = continuous glucose monitoring; CI = confidence interval; HAAF = hypoglycemia-associated autonomic failure; HbA1c = hemoglobin A1C; IAH = impaired awareness of hypoglycemia; T1D = type 1 diabetes.
Project description:To compare the performance of a professional continuous glucose monitoring (proCGM) and a personal continuous glucose monitoring (persCGM) system worn in parallel under standardized conditions in individuals with type 1 diabetes (T1D), two CGM systems (iPro2 - proCGM; Minimed 640G - persCGM) worn in parallel using the same sensor (Enlite 2) were compared. Ten people with T1D were included in this single-centre, open-label study in which CGM performance was evaluated. The study consisted of a 24-hours inpatient phase (meals, exercise, glycaemic challenges) and a 4-day home phase. Analyses included fulfilment of ISO 15197:2013 criteria, mean absolute relative difference (MARD), Parkes Error Grid and Bland-Altman plots. During the inpatient stay, ISO 15197:2013 criteria fulfilment was 58.4% (proCGM) and 57.8% (persCGM). At home, the systems met ISO 15197:2013 criteria by 66.5% (proCGM) and 65.3% (persCGM). No difference of MARD in inpatient phase (19.1 ± 16.7% vs. 19.0 ± 19.6; P = 0.83) and home phase (18.6 ± 26.8% vs. 17.4 ± 21.3%, P = 0.87) was observed. All sensors performed less accurately during hypoglycaemia. ProCGM and persCGM showed similar performance during daytime and night-time for the inpatient and the home phase. However, sensor performance was reduced during hypoglycaemia for both systems.
Project description:Automated insulin delivery (also known as closed loop, or artificial pancreas) has shown potential to improve glycaemic control and quality of life in people with type 1 diabetes (T1D). Automated insulin delivery devices incorporate an insulin pump with continuous glucose monitoring(CGM) and an algorithm, and adjust insulin in real time. This study aims to establish the safety and efficacy of a hybrid closed-loop (HCL) system in a long-term outpatient trial in people with T1D aged 12 -<25 years of age, and compare outcomes with standard therapy for T1D as used in the contemporary community.This is an open-label, multicentre, 6-month, randomised controlled home trial to test the MiniMed Medtronic 670G system (HCL) in people with T1D aged 12 -<25 years, and compare it to standard care (multiple daily injections or continuous subcutaneous insulin infusion (CSII), with or without CGM). Following a run-in period including diabetes and carbohydrate counting education, dosage optimisation and baseline glucose control data collection, participants are randomised to either HCL or to continue on their current treatment regimen. The primary aim of the study is to compare the proportion of time spent in target sensor glucose range (3.9-10.0?mmol/L) on HCL versus standard therapy. Secondary aims include a range of glucose control parameters, psychosocial measures, health economic measures, biomarker status, user/technology interactions and healthcare professional expectations. Analysis will be intention to treat. A study in adults with an aligned design is being conducted in parallel to this trial.Ethics committee permissions were gained from respective institutional review boards. The findings of the study will provide high-quality evidence on the role of HCL in clinical practice.
Project description:IN BRIEF A patient-centered approach to device design can provide important advantages in optimizing diabetes care technology for broadened adoption and improved adherence. Results from two surveys of people with diabetes and the parents of children with diabetes (n = 1,348) regarding continuous glucose monitoring (CGM) devices reveal the importance of the concept of "user burden" in patients' and caregivers' evaluations of the acceptability of available devices. Survey respondents' strongly favorable reactions to a proposed 1-year, fully implanted CGM device with no skin-attached components further confirm that minimizing system obtrusiveness will likely be of significant value in reducing hurdles to CGM device use and adherence.
Project description:OBJECTIVE:This study evaluated the societal cost-effectiveness of continuous glucose monitoring (CGM) in patients with type 1 diabetes (T1D) using multiple insulin injections. RESEARCH DESIGN AND METHODS:In the Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIAMOND) trial, 158 patients with T1D and HbA1c ?7.5% were randomized in a 2:1 ratio to CGM or control. Participants were surveyed at baseline and 6 months. Within-trial and lifetime cost-effectiveness analyses were conducted. A modified Sheffield T1D policy model was used to simulate T1D complications. The main outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS:Within the 6-month trial, the CGM group had similar QALYs to the control group (0.462 ± 0.05 vs. 0.455 ± 0.06 years, P = 0.61). The total 6-month costs were $11,032 (CGM) vs. $7,236 (control). The CGM group experienced reductions in HbA1c (0.60 ± 0.74% difference in difference [DiD]), P < 0.01), the daily rate of nonsevere hypoglycemia events (0.07 DiD, P = 0.013), and daily test strip use (0.55 ± 1.5 DiD, P = 0.04) compared with the control group. In the lifetime analysis, CGM was projected to reduce the risk of T1D complications and increase QALYs by 0.54. The incremental cost-effectiveness ratio (ICER) was $98,108 per QALY for the overall population. By extending sensor use from 7 to 10 days in a real-world scenario, the ICER was reduced to $33,459 per QALY. CONCLUSIONS:For adults with T1D using multiple insulin injections and still experiencing suboptimal glycemic control, CGM is cost-effective at the willingness-to-pay threshold of $100,000 per QALY, with improved glucose control and reductions in nonsevere hypoglycemia.