In a 13-week, randomized trial involving persons 6 to 79 years of age with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction in the glycated hemoglobin level than ...standard care.
OBJECTIVE: Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in ...young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS: After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA1c at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia. RESULTS: The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA1c was –0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA1c (rs = –0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS: CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.
Background:
The purpose of this article is to describe challenges associated with successful use of continuous glucose monitoring (CGM) by young children with type 1 diabetes (T1D) and to detail the ...techniques and products used to improve the duration of sensor wear.
Methods:
The DirecNet Study Group conducted 2 studies in 169 children with T1D between the ages of 1 and 9 years who were instructed to wear a CGM device daily. Problems related to skin irritation and sensor adhesiveness in these young children presented challenges to daily use of the CGM. Study coordinators instituted a variety of techniques using commercially available products to attempt to overcome these problems.
Results:
Three primary factors that contributed to reduced CGM use were identified: the limited body surface area in smaller children, ambient temperature and humidity, as well as the type and duration of physical activity. Using supplemental products to minimize the impact of these factors resulted in improved adherence and reduced skin irritation.
Conclusion:
Achieving satisfactory adhesion of the CGM sensor and transmitter may involve finding the right supplemental product or combination of products through trial and error. Optimizing adhesion and minimizing skin irritation can significantly improve duration of use and tolerability of CGM devices by young children.
Objective
To examine the feasibility of continuous glucose monitoring (CGM) use in very young children with type 1 diabetes (T1D).
Research design and methods
Twenty‐three children less than 4 yr of ...age with T1D were provided with a FreeStyle Navigator® (n = 21) or a Paradigm® (n = 2) CGM device. At baseline, mean age was 3.0 ± 0.8 yr, mean hemoglobin A1c (HbA1c) was 8.0 ± 0.8%, 10 were using an insulin pump and 13 were on multiple daily injections. CGM use was evaluated over a 6‐month period.
Results
Three children dropped out of the study before the end of 6 months. Among the 20 children who completed 6 months of follow‐up, CGM use in month 6 was ≥6 d/wk in 9 (45%), 4 ≤ 6 d/wk in 2 (10%), and <4 d/wk in 9 (45%). Skin reactions were minimal. Although there was no detectable change in mean HbA1c between baseline and 6 months (7.9 and 8.0%, respectively), there was a high degree of parental satisfaction with CGM as measured on the CGM satisfaction scale questionnaire. A high percentage of glucose values were in the hyperglycemic range, and biochemical hypoglycemia was infrequent.
Conclusion
More than 40% of very young children were able to safely use CGM on a near‐daily basis after 6 months. CGM demonstrated frequent hyperglycemic excursions, with a large variability in glucose readings. Although improvement in glycemic control was not detected in the group as a whole, parental satisfaction with CGM was high.
The evaluation of patient-reported outcomes (e.g. impact, satisfaction) is important in trials of continuous glucose monitoring (CGM). We evaluated psychometric properties of the CGM Satisfaction ...Scale (CGM-SAT) and the Glucose Monitoring Survey (GMS).
CGM-SAT is a 44-item scale on which patients (n=224) or parents (n=102) rated their experience with CGM over the prior 6 months. GMS is a 22-item scale on which patients (n=447) or parents (n=221) rated the blood glucose monitoring system they were using (home glucose meter with or without CGM) at baseline and 6 months.
The alpha coefficient for the CGM-SAT was > or = 0.94 for all respondents and for the GMS was > or = 0.84 for all respondents at baseline and 6 months. Parent-youth agreement was 0.52 for the CGM-SAT at 6 months and 0.24 and 0.20 for the GMS at baseline and 6 months for the Standard Care Group, respectively. Test-retest reliability of the GMS at 6 months for controls was r=0.76 for adult patients, 0.63 for pediatric patients, and 0.43 for parents. Factor analysis isolated measurement factors for the CGM-SAT labeled Benefits of CGM and Hassles of CGM, accounting for 33% and 9% of score variance, respectively. For the GMS, two factors emerged: Glucose Control and Social Complications, accounting for 28% and 9% of variance, respectively. Significant correlations of CGM-SAT with frequency of CGM use between 6 months and baseline and GMS with frequency of conventional daily self-monitoring of blood glucose at baseline support their convergent validity.
The CGM-SAT and GMS are reliable and valid measures of patient-reported CGM outcomes.
OBJECTIVE: To determine exposure to hyper- and hypoglycemia using blinded continuous glucose monitoring (CGM) profiles in youth with type 1 diabetes (T1D) with residual β-cell function during the ...first year of insulin treatment. RESEARCH DESIGN AND METHODS: Blinded, 3–7 day CGM profiles were obtained in 16 short-term T1D patients (age 8–18 years, T1D duration 6–52 weeks) who had peak C-peptide levels ranging from 0.46 to 1.96 nmol/L during a mixed-meal tolerance test. Results in this short-term group were compared with those in 34 patients with well-controlled, longer-term T1D (duration ≥5 years), matched for age and A1C with the short-term T1D group, and with those in 26 age-matched nondiabetic individuals. RESULTS: Despite matching for A1C, and therefore similar mean sensor glucose levels in the two T1D groups, short-term T1D participants had a lower frequency of hypoglycemia (0.3 vs. 7.6%, P < 0.001), a trend toward less hyperglycemia (17 vs. 32%, P = 0.15), and a greater percentage in the target range (median 77 vs. 60%, P = 0.02). Indeed, the percentage of sensor glucose levels ≤70 mg/dL in the short-term T1D group (0.3%) did not differ from those in the nondiabetic group (1.7%, P = 0.73). The coefficient of variation of sensor glucose levels (an index of glucose variability) was lower in short-term vs. longer-term T1D participants (27 vs. 42%, respectively, P < 0.001). CONCLUSIONS: In youth with short-term T1D who retain residual β-cell function, there is negligible exposure to hypoglycemia and lower glucose variability than in youth with well-controlled T1D of longer duration.
This article describes our experience with inpatient hybrid closed-loop control (HCLC) initiated shortly after the diagnosis of type 1 diabetes in a randomized trial designed to assess the ...effectiveness of inpatient HCLC followed by outpatient sensor-augmented pump (SAP) therapy on the preservation of β-cell function.
Forty-eight individuals with newly diagnosed type 1 diabetes and positive pancreatic autoantibodies (7.8-37.7 years old) received inpatient HCLC therapy for up to 93 h, initiated within 7 days of diagnosis.
On initiation of HCLC, mean glucose concentration was 240±100 mg/dL. During the first day of HCLC, median of the participant's mean glucose concentrations fell rapidly to 146 mg/dL, a level of control that was sustained on Days 2 and 3 (138 mg/dL and 139 mg/dL, respectively). By Day 3, the median percentage of glucose values >250 and <60 mg/dL was <1%. During the first 2 weeks of SAP treatment at home, the median participant mean glucose level was 126 mg/dL (interquartile range, 117, 137 mg/dL), and the median percentage of values between 71 and 180 mg/dL was 85% (interquartile range, 80%, 90%).
Inpatient HCLC followed by outpatient SAP therapy can provide a safe and effective means to rapidly reverse glucose toxicity and establish near-normal glycemic control in patients with newly diagnosed type 1 diabetes.
Despite improvements for management of type 1 diabetes (T1D), patients have difficulty achieving glycated hemoglobin (A1c) levels recommended by the Diabetes Control and Complications Trial (DCCT). ...Two multicenter randomized trials were conducted to evaluate benefit of using a continuous glucose monitor (CGM) with standard glucose monitoring for T1D management. The primary study evaluated benefits of CGM in 322 patients with A1c >7.0 %. The secondary study evaluated 129 patients with A1c <7.0 %. In the primary study, CGM resulted in improvements in A1c at 6 m in subjects >25 years, but not those <25. However, all subjects using CGM regularly showed benefit. Improved A1c did not come with increased severe hypoglycemia as seen in the DCCT, and benefit was sustained over 1 year. In the secondary study, CGM use helped subjects maintain target A1c levels with reduced exposure to biochemical hypoglycemia. The data collected allowed for other analyses of important factors in T1D management.
PDF
