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Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.

ABSTRACT: INTRODUCTION:The impact of flash glucose monitoring technology on HbA1c in type 2 diabetes managed by basal bolus insulin is uncertain. Three parallel European retrospective non-interventional chart review studies collected data reported in medical records. Each country's study aim was to determine the effectiveness of the device on HbA1c when used by their population for 3-6 months as their standard of care for management of glycaemia in a real-world setting. METHODS:Medical records were eligible for adult patients with type 2 diabetes, on a basal bolus insulin regimen for 1 year or more, device use for 3 months or more before the start of the study, an HbA1c concentration up to 3 months prior to starting device use (patients were using blood glucose monitoring for self-management) between 64 and 108 mmol/mol (8.0-12.0%) plus an HbA1c determination 3-6 months after commencing flash glucose monitoring use. RESULTS:Records were analysed from 18 medical centres in Austria (n = 92), France (n = 88) and Germany (n = 183). Baseline HbA1c results, recorded up to 90 days before the start of device use, were comparable across the three countries and were reduced significantly by 9.6 ± 8.8 mmol/mol mean ± SD (Austria [0.9 ± 0.8%], p < 0.0001), 8.9 ± 12.5 mmol/mol (France [0.8% ± 1.1], p < 0.0001) and 10.1 ± 12.2 mmol/mol (Germany [0.9% ± 1.1], p < 0.0001). No significant differences were detected between age group, sex, BMI or duration of insulin use. CONCLUSIONS:Three European real-world, chart review studies in people with type 2 diabetes managed using basal bolus insulin therapy each concluded that HbA1c was significantly reduced after changing to use of flash glucose monitoring for 3-6 months in a real-world setting.

SUBMITTER: Kroger J

PROVIDER: S-EPMC6965548 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAmong self-care measures, the self-monitoring of blood glucose (SMBG) is a critical component for checking blood glucose levels. In addition, there is growing evidence suggesting that digital technologies are being adopted as an additional method for health care systems to increase patient contact. However, for patients with non-insulin-treated diabetes mellitus type 2 (DMT2), the value of SMBG was inconsistent among studies, and the evidence for digital technologies from real-world clinical practice is still limited.ObjectiveOur study aimed to assess patients with non-insulin-treated DMT2 who were receiving care from a single clinic and analyze whether the use of a diabetes management app and SMBG behavior would affect glycemic control in a real-world clinical setting.MethodsWe collaborated with a large clinic focused on diabetes care in Taiwan that had been using the Health2Sync mobile app and web-based Patient Management Platform to collect the data. The patients were divided into 2 groups (app-engaged-user group and only-data-uploader group) according to different activities in the app, and blood glucose was recorded every month from 1 to 6 months after registration in the app. A sample of 420 patients was included in the analysis, and a linear mixed model was built to investigate which factors affected the patients' blood glucose percentage change.ResultsUsing the mixed model coefficient estimates, we found that the percentage change was significantly negative when the only-data-uploader group was set as the baseline (t=-3.873, df=1.81 × 104; P<.001 for the patients of the app-engaged-user group). We found that for patients with shorter diabetes duration, their blood glucose decreased more than patients with longer diabetes duration (t=2.823, df=1.71 × 104; P=.005 for the number of years of diabetes duration). In addition, we found that for younger patients, their blood glucose decreased more than older patients (t=2.652, df=1.71 × 104; P=.008 for the age of the patients). Furthermore, the patients with an education level of junior high school or lower saw a significantly greater decrease in blood glucose percentage change than the patients with an education level of senior high school or higher (t=4.996, df=1.72 × 104; P<.001 for the patients with an education level of senior high school or higher). We also found that the count of blood glucose measured enlarged the decrease along the interaction months (t=-8.266, df=1.97 × 104; P<.001 for the nth month × the count of blood glucose in the nth month). Lastly, the gender of the patients did not significantly affect the percentage change (t=0.534, df=1.74 × 104; P=.59 for female patients).ConclusionsOur analysis showed the following: the blood glucose percentage change of the patients in the app-engaged-user group dropped more than that in the only-data-uploader group; shorter diabetes duration is associated with a steeper decrease in the patients' blood glucose percentage change; the percentage decrease in blood glucose change in younger patients is greater than older patients; the blood glucose percentage change of the patients with an education level of junior high school or lower dropped more than those with an education level of senior high school or higher; and the more frequently the patients test SMBG each month, the greater the decrease in the patients' blood glucose percentage. Further studies can be performed to consider the differences in daily behaviors such as exercise and diet across the patients and whether these factors could have vital effects on glycemic control.

Project description:IntroductionCombination use of onabotulinumtoxinA and calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) has the potential to be more effective than either therapy alone for migraine prevention.MethodsThis retrospective, longitudinal chart review included adults with chronic migraine treated at one clinical site with ≥ 2 consecutive cycles of onabotulinumtoxinA and ≥ 1 month of subsequent combination treatment with CGRP mAbs. Charts at time of mAb prescription (baseline) and up to four visits ~ 3, 6, 9, and 12 months post-baseline were reviewed for safety, tolerability, and outcome measures (monthly headache days [MHDs], headache intensity, and migraine-related disability [MIDAS]).ResultsOf 300 charts reviewed, 257 patients met eligibility criteria (mean age: 50 years; 82% women). Average headache frequency was 21.5 MHDs before initiation of onabotulinumtoxinA and 12.1 MHDs before adding CGRP mAb therapy. Prescribed mAbs were erenumab (78%), fremanezumab (6%), and galcanezumab (16%). Over the entire study, patients discontinued CGRP mAb more frequently than onabotulinumtoxinA (23 vs. 3%). Adverse events occurred in 28% of patients, most commonly constipation (9%). Compared with onabotulinumtoxinA alone (baseline), MHDs decreased significantly at all visits (mean decrease: 3.5-4.0 MHDs over ~ 6-12 months of combination treatment); 45.1% of patients had clinically meaningful improvement in migraine-related disability (≥ 5-point reduction in MIDAS score) after ~ 6 months.ConclusionsIn this real-world study, combination treatment with onabotulinumtoxinA and CGRP mAbs was well tolerated, with no new safety signals identified, and was associated with additional clinically meaningful benefits. More real-world and controlled trials should be considered to further assess safety and potential benefits of combination treatment. Video abstract: Real-world data suggests that CGRP inhibitors improve onabotulinumtoxinA efficacy for chronic migraine (MP4 20,067 kb).

Project description:IntroductionOptimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP).Methods and analysisGeneral Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking 'does intermittent r-CGM in adults with T2D in primary care improve HbA1c?'Primary outcomeAbsolute difference in mean HbA1c at 12?months follow-up between intervention and control arms.Secondary outcomes(a) r-CGM per cent time in target (4-10?mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes).EligibilityAged 18-80 years, T2D for ?1?year, a (past month) HbA1c>5.5?mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four?months). Our general glycaemic target is 53?mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64?mmol/mol (8%)).Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1?hour education by a specialist diabetes nurse.The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5?mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition).Ethics and disseminationUniversity of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration number>ACTRN12616001372471; Pre-results.

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Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.

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