Background: Young children affected by Type 1 Diabetes (T1D) are prone to glucose fluctuations and hardly reach a stable glycometabolic control, especially when treated with a Multiple Daily Insulin Injections (MDI) scheme. The recent Real-Time Continuous Glucose Monitoring (RT-CGM) System, Dexcom G5, the only available device registered for non-adjunctive insulin intervention, potentially facilitates a better management of the disease. Evidence regarding CGM effectiveness among children treated with MDI is limited.
Aim of the study: To evaluate the effect of the RT-CGM on glycometabolic control, glucose variability and hypoglycemia in T1D children under 10 years, treated with MDI, compared to a control group traditionally monitored with Self Monitoring of Blood Glucose (SMBG).
Patients and Methods: Seventy-three T1D children under 10 years were enrolled in this observational study. Patients were subdivided into four groups:
1. 21 children at onset of diabetes monitored with RT-CGM
2. 29 control children at onset of diabetes monitored with SMBG
3. 10 children with Diabetes Duration > 1 year monitored with RT-CGM
4. 13 control children with consolidated T1D monitored with SMBG
Groups were homogeneous for age (respectively 4.3±2.39, 4.0±1.79, 7.0±2.17 and 6.7±2.60 years) and HbA1c (respectively 10.9±2.02, 10.7±1.26, 7.5±0.45 and 7.8±1.14%). After 12 (T1) and 24 weeks (T2) the following parameters were evaluated: HbA1c, Time in Range (70180 mg/dl), Time in Hypo (<70 mg/dl), Time in Hyper (>180 mg/dl) and Coefficient of Variation (CV). At the end of the study all parents were administered the GMSST1 questionnaire to evaluate the device satisfaction.
Results: Groups 1 and 3 used RT-CGM for 90.19±8.52% of time at T1 and for 91.37±8.33% of time at T2. HbA1c resulted significantly reduced at T2 in the RT-CGM treated groups as compared to control groups (7.2±0.72% vs 7.7±0.94%; P<0.007). TIR resulted significantly (P < 0.03) increased at T2 in the RT-CGM treated groups as compared to control groups. Reduction of Time in Hypo was reported for all patients using CGM, both at onset of diabetes and also during consolidated disease (data statistically non significative). GMSST1 high scores have been reported for all items.
Conclusions: RT-CGM Dexcom G5 was proven to have a clinically significant effect on glucose control in very young children with T1D treated with a MDI scheme, both at onset of diabetes and during diseases follow-up.
27 Sep 2018 - 29 Sep 2018