Research paperOptimization of insulin regimen and glucose outcomes with short-term real-time continuous glucose monitoring (RT-CGM) in type 1 diabetic children with sub-optimal glucose control on multiple daily injections: The pediatric DIACCOR study
Introduction
Most of the cases of type 1 diabetes (T1D) are diagnosed in children and adolescents. T1D management in children has unique characteristics, as food intake and physical activity are quite unpredictable in toddlers while hormonal changes in growing children may alter insulin sensitivity and diabetes management. Although insulin analogs, insulin pumps, and insulin bolus calculators have been helpful with these issues, optimal glucose control often remains very difficult to achieve in youths. Nevertheless, chronic hyperglycemia can ultimately lead to micro- and macrovascular complications [1] as well as to cognitive impairment [2] and there is also concern about the long-term consequences of hypoglycemia and mostly severe hypoglycemia (SH). In fact, when SH events occur before the age of 6 years, subtle changes in cognitive performances can be observed at young adult age [3].
Adequate glucose control can be reached in children with T1D with either multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII), which usually leads to better glucose control, as was reported in the SWEET registry (16,570 children worldwide) [4] in which 44.4% of the children were treated with CSII. In France, CSII cost is entirely covered by the national health insurance. However, some patients or their family remain reluctant to use CSII treatment. Pump rejection has been reported in young patients for mainly social/psychological reasons, while pump discontinuation was associated with previous poor glucose control [5].
It was clearly shown in adults that the use of long-term real-time continuous glucose monitoring (RT-CGM) helps to identify glucose profiles and results in HbA1c lowering, improvement in glucose variability, and reduction in the incidence of hypoglycemia events. Unlike in adults, early trials using CGM, such as the JDRF study, failed to show a benefit of RT-CGM in children or teens [6]. However, only 30% (in the 15–24-year-old group) to 50% (in the 8–14-year-old group) of the young patients from the JDRF study used the sensor more than 6 days per week, whereas it was shown that CGM efficacy is clearly related to adherence [7]. This points out the difficulty of wearing a glucose sensor on a long-term basis in youths even with the newest devices: in the T1D Exchange Registry, 26% of the 18–25-year-olds were CGM users compared with 40–48% in the older age groups [8]. Nevertheless, the effect of CGM in a pediatric population can be the same as in an adult population provided the wearing of the sensor is long enough, as was shown in the SWITCH study (mean wearing of the sensor: 80% of the time, 73% in youths) [9].
The role of short-term diagnostic CGM in helping patients to optimize their insulin regimen has not been examined in a large dedicated study. Only two studies reported some treatment changes [10] or treatment intensification [11] after a short-term CGM course in children. One study reported the effect of advice on bolus timing/use of active insulin after a 3-day masked CGM course in youths [12]. Thus, we designed the DIACCOR Study, which was a national multicenter study aiming to look in real-life conditions at the impact of short-term (7-day) RT-CGM on the insulin treatment strategy and more specifically on the decision for either MDI intensification or switching from MDI to CSII or educational reinforcement. Since the pediatric population differs from adults, with the parents being very much involved in therapeutic decisions and with a strong interaction between the family and the pediatrician, we designed a specific pediatric study and report the results here.
Section snippets
Design of the study
DIACCOR was a French multicenter longitudinal observational study including an adult study [13] and the present pediatric study. Investigators were diabetes-specialized pediatricians and were selected out of a national list of physicians with experience in the use of CSII and CGM, whatever their practice (university hospital or non-university hospital). Pediatricians who accepted to participate enrolled the first three consecutive patients (up to 10 patients) who fulfilled inclusion criteria.
Population of the study
A total of 229 children and adolescents were included in the study by 74 physicians from September 2014 to October 2015. Clinical data were available for 211 patients (92.1%) and the initial CGM was performed on 183 patients (79.9%) (Fig. 1). The therapeutic decision was available for 175 patients (76.4%). Demographic characteristics are shown in Table 1. Age ranged from 3 to 18 years. Comorbidities were present in 18 children, the most frequent being autoimmune thyroiditis (n = 8) and asthma (n =
Discussion
While the usefulness of sensor-augmented MDI therapy has been widely demonstrated in T1D, specific issues exist in the pediatric population with potential negative effects of CGM [15]. Interferences of CGM on the quality of life could be a cause for the poor adherence of sensor wear in youth that has been consistently reported. Since adherence is necessary for CGM success, this could be the reason why most of the studies could not show CGM benefits in youths. Nevertheless, the impact on
Conclusion
This is the first real-life large study including children with uncontrolled T1D showing that diagnostic RT-CGM helps with treatment strategy by identifying control issues such as glucose variability and by giving tips for diabetes management and insulin treatment intensification. Diagnostic CGM induced changes in treatment and sometimes in CSII initiation. HbA1c improved significantly with MDI intensification and these trends were observed in the few children who switched to CSII or even those
Funding
Study funded by VitalAire France.
Disclosure of interest
S.P. reports personal fees from Vitalaire, during the conduct of the study, personal fees from Abbott, Bayer Diagnostics, Lifescan, Vitalaire, Novo Nordisk, Sanofi, Animas, and Janssen outside the submitted work, E.B.G. reports personal fees from Medtronic, Lilly, VitalAire, IsisDiabete, Dinno Santé outside the submitted work; E.L. declares the fees and payment from Vitalaire for statistical data analysis of the manuscript; P.B. reports grants from Serono, Vitalaire, Orkin, Lilly, Pfizer,
Acknowledgement
This study was sponsored by and funded by VitalAire France. Statistical analyses were performed by GECEM, 85-87, rue Gabriel Peri 92120 Montrouge, France. Editorial support was provided by Sylvie Picard, MD, PhD (Dijon, France). Funding for this assistance was provided by VitalAire France. The authors are very grateful to the patients and the patients’ families for their committed participation in the study; they also thank the nurses from Vitalaire France for their involvement in the study and
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