Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial

Abstract

Aims/hypothesis The objective of this study was to assess the impact of patient-led sensor-guided pump management on glycaemic control, and compare the effect with that of standard insulin pump therapy. Methods An open multicentre parallel randomised controlled trial was conducted at five tertiary diabetes centres. Participants aged 13.0-40.0 years with well-controlled type 1 diabetes were randomised 1:1 to either study group for 3 months. Randomisation was carried out using a central computer-generated schedule. Participants in the intervention group used sensor-guided pump management; no instructive guidelines in interpreting real-time data were provided ('patient-led' use). Participants in the control group continued their original insulin pump regimen. Continuous glucose monitoring (CGM) and HbA 1c level were used to assess outcomes. The primary outcome was the difference in the proportion of time in the target glycaemic range during the 3 month study period (derived from CGM, target range 4-10 mmol/l). Secondary outcomes were difference in HbA 1c , time in hypoglycaemic (≤3.9 mmol/l) and hyperglycaemic (≥10.1 mmol/l) ranges and glycaemic variability. Results Sixty-two participants were recruited and randomised; 5/31 and 2/31 withdrew from intervention and control groups, respectively, leaving 26/31 and 29/31 for the intention-to-treat analyses. When adjusted for baseline values, the mean end-of-study HbA 1c was 0.43% lower in the intervention group compared with the control group (95% CI 0.19 to 0.75%; p=0.009). No difference was observed in CGM-derived time in target (measured difference 1.72; 95% CI −5.37 to 8.81), hypoglycaemic (0.54; 95% CI −3.48 to 4.55) or hyperglycaemic (−2.18; 95% CI −10.0 to 5.69) range or in glycaemic variability (−0.29; 95% CI −0.34 to 0.28). Within the intervention group, HbA 1c was 0.51% lower in participants with sensor use ≥70% compared with participants with sensor use <70% (95% CI −0.98 to −0.04, p=0.04). Five episodes of device malfunction occurred. Conclusions/interpretation Individuals established on insulin pump therapy can employ sensor-guided pump management to improve glycaemic control. An apparent dose-dependent effect of sensor usage was noted; however, Diabetologia

High Reported Treatment Satisfaction in People With Type 1 Diabetes Switching to Latest Generation Insulin Pump Regardless of Previous Therapy

“…4 Use of insulin pumps in combination with continuous glucose monitoring (CGM) technologies has been shown to further improve clinical outcomes. [5][6][7] Despite these benefits, many individuals with T1D who are treated with multiple daily insulin injections (MDI) may be reluctant to make the transition to an insulin pump. In focus group interviews with 30 adults with T1D who were currently using insulin pumps, Ritholz and colleagues identified 4 major themes regarding respondents' reluctance to transition to insulin pump therapy.…”

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

“…Careful initial training of patients [21,32,33] and educational reinforcement [30] are also key elements in the improvement of HbA 1c .…”

“…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]. This is not the case in the paediatric groups in the JDRF study [24]: compared to adults, the paediatric population had less good adherence to the use of sensors (83% of adults vs 50% of children and 30% of adolescents).…”

“…• the effectiveness of CGM is significantly correlated to the length of time sensors are used [24,31,32,52]. Efforts to increase sensor use are important, particularly in the paediatric population.…”

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].…”