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      Continuous Glucose Monitoring: A Brief Review for Primary Care Practitioners

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          Abstract

          Abstract

          Glycated hemoglobin A1c (HbA1c) is routinely used as a marker of average glycemic control, but it fails to provide data on hypoglycemia and glycemic variability, both of which are associated with adverse clinical outcomes. Self-monitoring of blood glucose (SMBG), particularly in insulin-treated patients, is a cornerstone in the management of patients with diabetes. SMBG helps with treatment decisions that aim to reduce high glucose levels while avoiding hypoglycemia and limiting glucose variability. However, repeated SMBG can be inconvenient to patients and difficult to maintain in the long term. By contrast, continuous glucose monitoring (CGM) provides a convenient, comprehensive assessment of blood glucose levels, allowing the identification of high and low glucose levels, in addition to evaluating glycemic variability. CGM using newer detection and visualization systems can overcome many of the limitations of an HbA1c-based approach while addressing the inconvenience and fragmented glucose data associated with SMBG. When used together with HbA1c monitoring, CGM provides complementary information on glucose levels, thus facilitating the optimization of diabetes therapy while reducing the fear and risk of hypoglycemia. Here we review the capabilities and benefits of CGM, including cost-effectiveness data, and discuss the potential limitations of this glucose-monitoring strategy for the management of patients with diabetes.

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          Sanofi US, Inc.

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          Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry.

          Kellee Miller, Nicole C Foster, Roy Beck … (2015)
          To examine the overall state of metabolic control and current use of advanced diabetes technologies in the U.S., we report recent data collected on individuals with type 1 diabetes participating in the T1D Exchange clinic registry. Data from 16,061 participants updated between 1 September 2013 and 1 December 2014 were compared with registry enrollment data collected from 1 September 2010 to 1 August 2012. Mean hemoglobin A1c (HbA1c) was assessed by year of age from 75 years. The overall average HbA1c was 8.2% (66 mmol/mol) at enrollment and 8.4% (68 mmol/mol) at the most recent update. During childhood, mean HbA1c decreased from 8.3% (67 mmol/mol) in 2-4-year-olds to 8.1% (65 mmol/mol) at 7 years of age, followed by an increase to 9.2% (77 mmol/mol) in 19-year-olds. Subsequently, mean HbA1c values decline gradually until ∼30 years of age, plateauing at 7.5-7.8% (58-62 mmol/mol) beyond age 30 until a modest drop in HbA1c below 7.5% (58 mmol/mol) in those 65 years of age. Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain all too common complications of treatment, especially in older (SH) and younger patients (DKA). Insulin pump use increased slightly from enrollment (58-62%), and use of continuous glucose monitoring (CGM) did not change (7%). Although the T1D Exchange registry findings are not population based and could be biased, it is clear that there remains considerable room for improving outcomes of treatment of type 1 diabetes across all age-groups. Barriers to more effective use of current treatments need to be addressed and new therapies are needed to achieve optimal metabolic control in people with type 1 diabetes.
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            Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

            Thomas Haak, Hélène Hanaire, Ramzi A Ajjan … (2016)
            Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. Trial registration ClinicalTrials.gov identifier: NCT02082184. Funding Abbott Diabetes Care. Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users.
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              Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group.

              John M. Lachin, Saul Genuth, Patricia Cleary … (2000)
              Among patients with type 1 diabetes mellitus, intensive therapy (with the aim of achieving near-normal blood glucose and glycosylated hemoglobin concentrations [hemoglobin A1c]) markedly reduces the risk of microvascular complications as compared with conventional therapy. To assess whether these benefits persist, we compared the effects of former and intensive conventional therapy on the recurrence and severity of retinopathy and nephropathy for four years after the end of the Diabetes Control and Complications Trial (DCCT). At the end of the DCCT, the patients in the conventional-therapy group were offered intensive therapy, and the care of all patients was transferred to their own physicians. Retinopathy was evaluated on the basis of centrally graded fundus photographs in 1208 patients during the fourth year after the DCCT ended, and nephropathy was evaluated on the basis of urine specimens obtained from 1302 patients during the third or fourth year, approximately half of whom were from each treatment group. The difference in the median glycosylated hemoglobin values between the conventional-therapy and intensive-therapy groups during the 6.5 years of the DCCT (average, 9.1 percent and 7.2 percent, respectively) narrowed during follow-up (median during 4 years, 8.2 percent and 7.9 percent, respectively, P<0.001). Nevertheless, the proportion of patients who had worsening retinopathy, including proliferative retinopathy, macular edema, and the need for laser therapy, was lower in the intensive-therapy group than in the conventional-therapy group (odds reduction, 72 percent to 87 percent, P<0.001). The proportion of patients with an increase in urinary albumin excretion was significantly lower in the intensive-therapy group. The reduction in the risk of progressive retinopathy and nephropathy resulting from intensive therapy in patients with type 1 diabetes persists for at least four years, despite increasing hyperglycemia.
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                Author and article information

                Contributors
                Ramzi Ajjan: R.Ajjan@leeds.ac.uk
                Journal
                Journal ID (nlm-ta): Adv Ther
                Journal ID (iso-abbrev): Adv Ther
                Title: Advances in Therapy
                Publisher: Springer Healthcare (Cheshire )
                ISSN (Print): 0741-238X
                ISSN (Electronic): 1865-8652
                Publication date (Electronic): 18 January 2019
                Publication date PMC-release: 18 January 2019
                Publication date (Print): 2019
                Volume: 36
                Issue: 3
                Pages: 579-596
                Affiliations
                [1 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, Leeds Institute of Cardiovascular and Metabolic Medicine, The LIGHT Laboratories, , University of Leeds, ; Leeds, UK
                [2 ]GRID grid.439905.2, Endocrinology and Metabolic Medicine, York Teaching Hospital, NHS Foundation Trust, ; York, UK
                [3 ]Department of Medicine and Community and Family Medicine, Duke Southern Regional AHEC, Fayetteville, NC USA
                Article
                Publisher ID: 870
                DOI: 10.1007/s12325-019-0870-x
                PMC ID: 6824352
                PubMed ID: 30659511
                SO-VID: 5218cec4-84e2-4918-9add-87824f2d6fef
                Copyright © © The Author(s) 2019
                History
                Date received : 1 November 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004339, Sanofi;
                Categories
                Subject: Review
                Custom metadata
                issue-copyright-statement © Springer Healthcare Ltd., part of Springer Nature 2019

                Keywords: continuous glucose monitoring,diabetes,flash glucose monitoring,glycemic variability,hba1c,hypoglycemia
                Data availability:
                Keywords: continuous glucose monitoring, diabetes, flash glucose monitoring, glycemic variability, hba1c, hypoglycemia

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