Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes

Abstract

OBJECTIVETo assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes.RESEARCH DESIGN AND METHODSIn this randomized, controlled, multicenter study, 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A1c (HbA1c) <7.5% were randomly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearing a masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring. The primary outcome was the time spent in hypoglycemia (interstitial glucose concentration <63 mg/dL) over a period of 26 weeks. Analysis was by intention to treat for all randomized patients.RESULTSThe time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group (mean ± SD 0.48 ± 0.57 and 0.97 ± 1.55 h/day, respectively; ratio of means 0.49; 95% CI 0.26–0.76; P = 0.03). HbA1c at 26 weeks was lower in the continuous monitoring group than in the control group (difference −0.27%; 95% CI −0.47 to −0.07; P = 0.008). Time spent in 70 to 180 mg/dL normoglycemia was significantly longer in the continuous glucose monitoring group compared with the control group (mean hours per day, 17.6 vs. 16.0, P = 0.009).CONCLUSIONSContinuous glucose monitoring was associated with reduced time spent in hypoglycemia and a concomitant decrease in HbA1c in children and adults with type 1 diabetes.

Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies

“…After the 26-week intervention period, a greater reduction in time spent in hypoglycemia was demonstrated for the CGM group versus the SMBG group (0.48 -0.57 h/day vs. 0.97 -1.55 h/day respectively). 40 HbA1c was also lower in the CGM group than the control group (difference -0.27%, 95% CI -0.47 to -0.07; P = 0.008). 40 Time spent in the normoglycemic range was increased in the CGM group compared with controls.…”

“…Reduction in hypoglycemia was the specified outcome of a randomized, controlled clinical trial in children and adults whose HbA1c was <7.5% at screening. 40 Of the 120 patients, 33% used MDI and 44% were children. After the 26-week intervention period, a greater reduction in time spent in hypoglycemia was demonstrated for the CGM group versus the SMBG group (0.48 -0.57 h/day vs. 0.97 -1.55 h/day respectively).…”

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

“…Severe repeated hypoglycaemia [26] or hypoglycaemia unawareness [19] has even been among the exclusion criteria in certain studies. A study having as its principal objective the reduction of mild hypoglycaemias [35] demonstrates that the use of a CGM device for six months by patients with well-controlled type 1 diabetes (HbA 1c < 7.5%) treated by pump (the majority) or multiple injections makes possible a reduction by half of the time spent in hypoglycaemia (P = 0.03) and a supplementary improvement of HbA 1c (-0.27%, P = 0.0008) [35]. Another study recruited a small number of patients on the basis of frequency of hypoglycaemia (more than 6 episodes < 60 mg/ dl in the last 15 days) and showed a 50% reduction in the frequency of hypoglycaemias and a simultaneous reduction in HbA 1c when a CGM device as opposed to SBMG is used for three months [36].…”

“…In intention to treat (ITT), the results are significant in 7 studies in patients with good or bad glucose control at baseline [11,35]. In several studies, the improvement in HbA 1c is comparable in children or adolescents and adults [23,31,32,50].…”

Objectives and methods of the ORCHESTRA FOUNDATION Registry study: a multicenter observational study of the use of insulin pump therapy in pregnant women with type 1 diabetes mellitus in Poland.

“…Similarly, insulin pump use in pregnancy has been found to reduce HbA 1c levels in patients with T1DM without increasing the rate of severe hypoglycemia or ketoacidosis [23]. Both CSII and continuous glucose monitoring (CGM), alone or in combination as a sensor-augmented pump (SAP) or sensor-integrated pump (SIP) therapy, improve glycemic control by reducing HbA 1c from 0.4-1.2% [24][25][26][27][28][29][30]. The recent INTERPRET study, the largest and longest multicenter prospective study to date, has confirmed the effectiveness of CGM in pump users; data from 263 patients using SAP therapy under real-life conditions over 12 months revealed significantly lower rates of hospitalization, greater treatment satisfaction, and reduced fear of hypoglycemia compared to CGM nonusers [31].…”