Some patients with type 1 diabetes (T1D) are severely noncompliant; they rarely perform self-blood glucose measures and miss insulin injections. Their HbA1c is far above the target rate. Current guidelines do not recommend starting treatment with an insulin pump (continuous subcutaneous insulin infusion [CSII]) for these persons. The aim of this study was to determine whether a CSII associated with a flash glucose monitoring (FGM) device could reduce HbA1c without increasing the risk of acute events, diabetic ketoacidosis (DKA) and severe hypoglycemia (SH), in these patients. We conducted a 6-month nonrandomized, pilot prospective study. Patients with T1D on multiple daily injections who performed less than two self-blood glucose tests/day and had an HbA1c >9% were equipped with CSII and an FGM device. The primary composite endpoint was defined by a change in HbA1c ≥1% without any episode of DKA or SH during 6 months. Change in mean HbA1c, weight, treatment satisfaction, frequency of minor hypoglycemia, and ketoacidosis were secondary endpoints. Nineteen adults were included. Median (Q1-Q3) HbA1c at baseline was 10.8 (10.3-13.0), 14 participants did not perform any self-monitoring and 5 performed maximum two tests daily. Twelve participants (63%) (95% confidence interval 41%-81%) met the primary composite endpoint. Seventeen patients completed the study. HbA1c decreased by 2% (1.0-3.3) (P < 0.001), and satisfaction with treatment significantly improved. Three participants experienced SH and one a DKA, versus, respectively, five and eight in the year preceding the study. Participants scanned the sensor 4 (3-6) times per day and injected 3 (2.7-4.1) boluses per day. Weight increased significantly. An association of an insulin pump with an FGM device can be an effective and safe therapeutic option in severely nonadherent and noncompliant patients with high HbA1c.
Keywords: Continuous subcutaneous insulin infusion; Flash glucose monitoring; Glycemic control; Treatment compliance; Type 1 diabetes.