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      Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study

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          Abstract

          Randomized controlled trials evaluating real-time continuous glucose monitoring (RT-CGM) patients with type 1 diabetes (T1D) show improved glycemic control, but limited data are available on real-world use.

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          Most cited references20

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

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

            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 HbA1c 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 HbA1c 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 HbA1c 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, HbA1c 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 HbA1c 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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              Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1.

              We wanted to identify a five-item short form of the Problem Areas in Diabetes Scale and a single-item measure for rapid screening of diabetes-related emotional distress. Using an existing database of 1,153 patients with diabetes, we conducted a principal-components analysis to identify a set of five items and then conducted a reliability analysis and validity checks. From those five items, we identified the item with the strongest psychometric properties as a one-item screening tool. We identified a reliable and valid short version of the Problem Areas in Diabetes Scale (PAID) comprising five of the emotional-distress questions of the full PAID items (PAID-5, with items 3, 6, 12, 16, 19). The PAID-5 has satisfactory sensitivity (94%) and specificity (89%) for recognition of diabetes-related emotional distress. We also identified a one-item screening tool, the PAID-1 (Question 12: Worrying about the future and the possibility of serious complications), which has concurrent sensitivity and specificity of about 80% for the recognition of diabetes-related emotional distress. The PAID-5 and PAID-1 appear to be psychometrically robust short-form measures of diabetes-related emotional distress.
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                Author and article information

                Journal
                The Journal of Clinical Endocrinology & Metabolism
                The Endocrine Society
                0021-972X
                1945-7197
                March 2018
                March 2018
                March 01 2018
                January 12 2018
                : 103
                : 3
                : 1224-1232
                Affiliations
                [1 ]Department of Endocrinology, University Hospitals Leuven–Katholieke Universiteit Leuven, Leuven, Belgium
                [2 ]PhD Fellowship Strategic Basic Research of the Research Foundation–Flanders (Fonds Wetenschappelijk Onderzoek), Brussels, Belgium
                [3 ]Department of Endocrinology, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium
                [4 ]Department of Endocrinology, Diabetology and Metabolism, University of Antwerp–Antwerp University Hospital, Antwerp, Belgium
                [5 ]Department of Diabetes, Nutrition and Metabolic Disorders, Centre Hospitalier Universitaire Liege–Liege University, Liege, Belgium
                [6 ]Department of Endocrinology and Nutrition, Cliniques Universitaires St-Luc–Université Catholique de Louvain, Brussels, Belgium
                [7 ]Department of Endocrinology, Algemeen Ziekenhuis Sint-Jan Brugge AV, Bruges, Belgium
                [8 ]Department of Endocrinology, Imelda Hospital Bonheiden, Bonheiden, Belgium
                [9 ]Department of Endocrinology, Ghent University Hospital, Ghent, Belgium
                [10 ]Department of Endocrinology, Université Libre de Bruxelles–Hôpital Erasme, Brussels, Belgium
                [11 ]Department of Public Health and Primary Care, I-BioStat, KU Leuven–University of Leuven and Universiteit Hasselt, Leuven, Belgium
                [12 ]Diabeteskliniek, University Hospital Brussels–Vrije Universiteit Brussel, Brussels, Belgium
                Article
                10.1210/jc.2017-02498
                29342264
                268dbf04-ef06-494d-92ae-af8a8e56a67d
                © 2018
                History

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