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      The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial

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          Abstract

          Aims/hypothesis

          The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes.

          Methods

          Children and adults ( n = 153) on CSII with HbA 1c 7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA 1c levels between arms after 6 months.

          Results

          Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA 1c was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI −0.32%, −0.55% [−3.50, −6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA 1c reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively ( p = 0.40).

          Conclusions/interpretation

          Continuous glucose monitoring was associated with decreased HbA 1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.

          Trial registration

          ClinicalTrials.gov registration no. NCT00598663.

          Funding

          The study was funded by Medtronic International Trading Sarl Switzerland.

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          Most cited references12

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          Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes.

          Richard M. Bergenstal, William Tamborlane, Andrew Ahmann … (2010)
          Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors. In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level. At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group. In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.) 2010 Massachusetts Medical Society
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            Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005).

            P. Cleary, Paul Orchard, Rachel Miller-Lotan … (2009)
            Clinical treatment goals of type 1 diabetes mellitus (T1DM) have changed since the Diabetes Control and Complications Trial (DCCT) demonstrated reduced long-term complications with intensive diabetes therapy. There have been few longitudinal studies to describe the clinical course of T1DM in the age of intensive therapy. Our objective was to describe the current-day clinical course of T1DM. An analysis of the cumulative incidence of long-term complications was performed. The DCCT (1983-1993) assigned patients to conventional or intensive therapy. Since 1993, the DCCT has been observational, and intensive therapy was recommended for all patients. The Pittsburgh Epidemiology of Diabetes Complications (EDC) study is an observational study of patients with T1DM from Allegheny County, Pennsylvania. The study population comprised the DCCT T1DM cohort (N = 1441) and a subset of the EDC cohort (n = 161) selected to match DCCT entry criteria. In the DCCT, intensive therapy aimed for a near-normal glycemic level with 3 or more daily insulin injections or an insulin pump. Conventional therapy, with 1 to 2 daily insulin injections, was not designed to achieve specific glycemic targets. Main outcome measures included the incidences of proliferative retinopathy, nephropathy (albumin excretion rate >300 mg/24 h, creatinine level >or=2 mg/dL [to convert to micromoles per liter, multiply by 88.4], or renal replacement), and cardiovascular disease. After 30 years of diabetes, the cumulative incidences of proliferative retinopathy, nephropathy, and cardiovascular disease were 50%, 25%, and 14%, respectively, in the DCCT conventional treatment group, and 47%, 17%, and 14%, respectively, in the EDC cohort. The DCCT intensive therapy group had substantially lower cumulative incidences (21%, 9%, and 9%) and fewer than 1% became blind, required kidney replacement, or had an amputation because of diabetes during that time. The frequencies of serious complications in patients with T1DM, especially when treated intensively, are lower than that reported historically.
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              Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion.

              J C Pickup, A J Sutton (2008)
              Continuous subcutaneous insulin infusion (CSII) is a recommended treatment for reducing severe hypoglycaemia in Type 1 diabetes, but the change in hypoglycaemia compared with multiple daily insulin injections (MDI) is unclear. We therefore conducted a meta-analysis comparing severe hypoglycaemia and glycaemic control during CSII and MDI. Databases and literature (1996-2006) were searched for randomized controlled trials (RCTs) and before/after studies of > or = 6 months' duration CSII and with severe hypoglycaemia frequency > 10 episodes/100 patient years on MDI. In 22 studies (21 reports), severe hypoglycaemia during MDI was related to diabetes duration (P = 0.038) and was greater in adults than children (100 vs. 36 events/100 patient years, P = 0.036). Severe hypoglycaemia was reduced during CSII compared with MDI, with a rate ratio of 2.89 (95% CI 1.45 to 5.76) for RCTs and 4.34 (2.87 to 6.56) for before/after studies [rate ratio 4.19 (2.86 to 6.13) for all studies]. The reduction was greatest in those with the highest initial severe hypoglycaemia rates on MDI (P < 0.001). The mean difference in glycated haemoglobin (HbA(1c)) between treatments was less for RCTs [0.21% (0.13-0.30%)] than in before/after studies [0.72% (0.55-0.90%)] but strongly related to the initial HbA(1c) on MDI (P < 0.001). The severe hypoglycaemia rate in Type 1 diabetes was markedly less during CSII than MDI, with the greatest reduction in those with most severe hypoglycaemia on MDI and those with the longest duration of diabetes. The biggest improvement in HbA(1c) was in those with the highest HbA(1c) on MDI.
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                Author and article information

                Contributors
                T. Battelino: tadej.battelino@mf.uni-lj.si
                Journal
                Journal ID (nlm-ta): Diabetologia
                Journal ID (iso-abbrev): Diabetologia
                Title: Diabetologia
                Publisher: Springer-Verlag (Berlin/Heidelberg )
                ISSN (Print): 0012-186X
                ISSN (Electronic): 1432-0428
                Publication date (Electronic): 11 September 2012
                Publication date PMC-release: 11 September 2012
                Publication date (Print): December 2012
                Volume: 55
                Issue: 12
                Pages: 3155-3162
                Affiliations
                [1 ]UMC - University Children’s Hospital, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000 Ljubljana, Slovenia
                [2 ]Diabetes Unit, ICMDM Hospital Clínici Universitari, Barcelona, Spain
                [3 ]Glostrup Hospital, Glostrup, Denmark
                [4 ]Hospital Hietzing, Vienna, Austria
                [5 ]Steno Diabetes Center, Gentofte, Denmark
                [6 ]Groene Hart Ziekenhuis, Gouda, the Netherlands
                [7 ]Clinique Pediatrique, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg
                [8 ]Clinica Pediatrica, Servizio Diabetologia, Policlinico Umberto I, Rome, Italy
                [9 ]Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden
                Article
                Publisher ID: 2708
                DOI: 10.1007/s00125-012-2708-9
                PMC ID: 3483098
                PubMed ID: 22965294
                SO-VID: bc671b56-de8a-4bb7-baec-9bca4faf32f3
                Copyright © © The Author(s) 2012
                History
                Date received : 15 May 2012
                Date accepted : 31 July 2012
                Categories
                Subject: Article
                Custom metadata
                issue-copyright-statement © Springer-Verlag Berlin Heidelberg 2012

                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: continuous glucose monitoring,diabetes mellitus type 1,glycaemic control,insulin pump therapy,randomised controlled trial,sensor-augmented insulin pump therapy
                Data availability:
                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: continuous glucose monitoring, diabetes mellitus type 1, glycaemic control, insulin pump therapy, randomised controlled trial, sensor-augmented insulin pump therapy

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