Glycemic Patterns Detected by Continuous Subcutaneous Glucose Sensing in Children and Adolescents With Type 1 Diabetes Mellitus Treated by Multiple Daily Injections vs Continuous Subcutaneous Insulin Infusion

Abstract

Objective: To compare glycemic patterns by mode of therapy in children with type 1 diabetes mellitus using the Continuous Glucose Monitoring System (CGMS).Design: Open randomized crossover comparing 3 1 ⁄2 months of multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII).Setting: Tertiary care, university-affiliated medical center.Patients: Twenty-three children and adolescents with type 1 diabetes mellitus. Interventions:The CGMS was applied for 72 hours after 1 month and at the end of each study arm. Main Outcome Measures:Hemoglobin A 1c levels and glucose level profiles were compared between the 2 study arms and the 2 sensor applications for each arm.Results: The arms were similar for mean (SD) hemoglobin A 1c levels (CSII, 8.0% [0.8%]; and MDI, 8.2% [0.8%]) and glucose levels. Areas under the curve were significantly larger during MDI for nocturnal and 24-hour hypoglycemia (P=.01 and .04, respectively) and for postprandial hypoglycemia and hyperglycemia (P=.03 and .05, respectively). The rate of hyperglycemia increased during CSII (P =.03), but 24-hour duration and area under the curve for hyperglycemia were similar. Compared with the first CGMS reading in each arm, the second had a longer mean duration of postprandial withintarget glucose levels (P=.04), tendency for lower rate of diurnal hypoglycemic events (P=.1), shorter duration of nocturnal hypoglycemia (P=.05), and smaller 24-hour area under the curve for hypoglycemia (P =.04). Conclusions:Intensive treatment with CSII seemed to be associated with slightly better prebreakfast, postprandial, and within-target glucose profiles than MDI, as well as a smaller area under the curve for hypoglycemia. Lower hypoglycemia-related variables in the second sensor reading in each arm indicate that the CGMS may serve as an educational tool to decrease the rate and magnitude of hypoglycemia.

Continuous Glucose Monitoring

“…This technology has similarly been used in hyperglycemia in type 1 diabetic subjects using insulin pump therapy (65,66), type 1 diabetic subjects using insulin injections (67), pregnant women with (55)(56)(57)(58)(59)68) and without (68,69) diabetes, gastroparesis patients (70), and cystic fibrosis patients (71). Continuous glucose monitoring has also been used as a therapeutic tool to decrease the incidence and magnitude of hypoglycemia in three studies (46,72,73).…”

A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE)

“…In total, 10 [56][57][58]66,[74][75][76][77][78][79] of the 15 CGMS studies that reported on adverse events found no evidence of either skin irritation or inflammation and no adverse device-related events. Of the remaining five studies, one 41 reported seven device-related adverse events, all involving minor irritation of the sensor insertion site, and another 64 reported five adverse device-related events.…”

“…Amongst the other five studies the CGMS was worn once or more, 41 twice, 56 three times 58 or four times. 66,78 In the studies reporting device-related adverse events, the CGMS was worn once, 50 twice, 51,64 for an average of 18 days using seven sensors consecutively 76 or continuously for 9 days. 81 These findings need to be interpreted with caution as not all of these studies describe how, or at what time points, skin irritation, adverse events or tolerance of the device were assessed.…”

“…With regard to the CGMS, in the studies that require it to be worn more than once, similar patterns of declining use are not evident. 56,59,64,66,76,78,97 In the studies evaluating other continuous glucose monitoring devices, the devices tend to be worn either continuously or once for a short period of time, so these are considered in the next section on attrition rates.…”

Metabolic Control Targets for Patients with Type 1 Diabetes in Clinical Practice

“…As such, predictive information on trends during the different times of the day can be obtained (Manuel-y-Keenoy et al, 2004). The CGMS can also be used to evaluate the response of the glycaemia profile to specific treatment or therapeutic modalities such as, for example, the use of multiple doses of insulin vs. the CIIS (Weintrob et al, 2004). There are several studies that show the usefulness of CGMS in modifying treatment and achieving better metabolic control (Edelman et al, 2009;Leinung et al, 2010).…”