Dataset Information

Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial.

ABSTRACT: AIM:Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes. METHODS:Primary (n = 17) and secondary care centres (n = 5) randomised 148 type 2 diabetes patients into three groups: (A) self-monitoring of blood glucose (n = 52), (B) self-monitoring of blood glucose and two Libre Pro sensor wears (n = 46) or (C) self-monitoring of blood glucose and four sensor wears (n = 50). Primary endpoint was time in range (glucose 3.9-10 mmol/L) within group C comparing baseline with days 172-187. Predefined secondary endpoints included HbA1c, hypoglycaemia and quality of life measures analysed within and between groups (clinicaltrials.gov, NCT02434315). RESULTS:In group C, time in range in the first 14 days (baseline) and days 172-187 was similar at 15.0 ± 5.0 and 14.1 ± 4.7 h/day (mean ± SD), respectively, (p = 0.1589). In contrast, HbA1c reduced from baseline to study end within group C by 4.9 ± 8.8 mmol/mol (0.44% ± 0.81%; p = 0.0003). HbA1c was also lower in group C compared with A at study end by 5.4 ± 1.79 mmol/mol (0.48% ± 0.16%; p = 0.0041, adjusted mean ± SE), without increased time in hypoglycaemia (p = 0.1795). Treatment satisfaction scores improved in group C compared with A (p = 0.0225) and no device-related serious adverse events were reported. CONCLUSIONS:Libre Pro can improve HbA1c and treatment satisfaction without increasing hypoglycaemic exposure in insulin-treated type 2 diabetes individuals managed in primary/secondary care centres.

SUBMITTER: Ajjan RA

PROVIDER: S-EPMC6613178 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial.

Ajjan Ramzi A RA Jackson Neil N Thomson Scott A SA

Diabetes & vascular disease research 20190701 4

<h4>Aim</h4>Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes.<h4>Methods</h4>Primary (n = 17) and secondary care centres (n = 5) randomised 148 type 2 diabetes patients into three groups: (A) self-monitoring of blood glucose (n = 52), (B) self-monitoring of blood glucose and two Libre Pro sensor wears (n = 46) or (C) self-monitoring of blood glucose and four sensor wears (n = 50). Primary endpoint w ...[more]

PMID: 31271312

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Project description:BACKGROUND:This prospective single-center study recruited insulin-resistant continuous subcutaneous insulin infusion (CSII) therapy-naive patients with type 2 diabetes (T2D) using insulin analog-based multiple daily injections (MDI) therapy and metformin. METHODS:A total of 23 individuals with T2D (70% male), aged a mean ± standard deviation 57.2 ± 8.03 years, with body mass index of 36.2 ± 7.02 kg/m2, diabetes duration of 13.3 ± 4.64 years, and HbA1c of 10.0% ± 1.05% were randomly assigned to a CSII arm or an MDI continuation arm to explore glucose control, weight loss, total daily insulin dose (TDD), and insulin resistance. Insulin dosing was optimized over a 2-month run-in period. RESULTS:At 6 months, patients assigned to the CSII arm achieved a significant mean HbA1c reduction of -0.9% (95% confidence interval [CI] = -1.6, -0.1), while reducing their TDD by -29.8 ± 28.41 U/day (33% of baseline [92.1 ± 20.35 U/day]) and achieving body mass (BM) reduction of -0.8 ± 5.61 kg (0.98% of baseline [104.8 ± 16.15 kg]). MDI patients demonstrated a nonsignificant HbA1c reduction of -0.3% (95% CI = -0.8, 0.1) with a TDD reduction of 5% from baseline (99.0 ± 25.25 U/day to 94.3 ± 21.25 U/day), and a BM reduction of -1.0 ± 2.03 kg (0.99% of baseline [108.9 ± 20.55 kg]). After 6 months, the MDI arm crossed over to CSII therapy. At 12 months, patients continuing CSII demonstrated an additional mean 0.7% HbA1c reduction with 54.6% achieving HbA1c<8%. The final TDD reduction was -9.7 U/day in comparison to baseline; BM increased by 1.1 ± 6.5 kg from baseline. The MDI patients that crossed to CSII showed an HbA1c reduction of -0.5% ± 1.04%, HbA1c response rate of 27.3%, a TDD reduction of -17.4 ± 21.06 U/day, and a BM reduction of -0.3 ± 3.39 kg. Diabetic ketoacidosis or severe hypoglycemia did not occur in either arm. CONCLUSION:CSII therapy safely and significantly improved metabolic control with less insulin usage, with no sustainable reduction of BM, blood pressure, and lipid profile, in insulin-resistant T2D patients. Treatment adherence and satisfaction in these patients were excellent.

Project description:Introduction: Pediatric patients cared for in professional healthcare settings are at high risk of medication errors. Interventions to improve patient safety often focus on prescribing; however, the subsequent stages in the medication use process (dispensing, drug administration, and monitoring) are also error-prone. This systematic review aims to identify and analyze interventions to reduce dispensing, drug administration, and monitoring errors in professional pediatric healthcare settings. Methods: Four databases were searched for experimental studies with separate control and intervention groups, published in English between 2011 and 2019. Interventions were classified for the first time in pediatric medication safety according to the "hierarchy of controls" model, which predicts that interventions at higher levels are more likely to bring about change. Higher-level interventions aim to reduce risks through elimination, substitution, or engineering controls. Examples of these include the introduction of smart pumps instead of standard pumps (a substitution control) and the introduction of mandatory barcode scanning for drug administration (an engineering control). Administrative controls such as guidelines, warning signs, and educational approaches are lower on the hierarchy and therefore predicted by this model to be less likely to be successful. Results: Twenty studies met the inclusion criteria, including 1 study of dispensing errors, 7 studies of drug administration errors, and 12 studies targeting multiple steps of the medication use process. A total of 44 interventions were identified. Eleven of these were considered higher-level controls (four substitution and seven engineering controls). The majority of interventions (n = 33) were considered "administrative controls" indicating a potential reliance on these measures. Studies that implemented higher-level controls were observed to be more likely to reduce errors, confirming that the hierarchy of controls model may be useful in this setting. Heterogeneous study methods, definitions, and outcome measures meant that a meta-analysis was not appropriate. Conclusions: When designing interventions to reduce pediatric dispensing, drug administration, and monitoring errors, the hierarchy of controls model should be considered, with a focus placed on the introduction of higher-level controls, which may be more likely to reduce errors than the administrative controls often seen in practice. Trial Registration Prospero Identifier: CRD42016047127.

Dataset Information

Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial.

Publications

Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial.

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