scholarly journals Benefits of the addition of continuous or flash glucose monitoring versus standard practice using self-monitored blood glucose and haemoglobin A1c in the primary care of diabetes mellitus: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e050027
Author(s):  
Alexander Kieu ◽  
Romona Devi Govender ◽  
Linda Östlundh ◽  
Jeffrey King
Keyword(s):  
Diabetes Mellitus ◽  
Systematic Review ◽  
Primary Care ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Glucose Monitoring ◽  
Physician Satisfaction ◽  
Haemoglobin A1c ◽  
Flash Glucose Monitoring ◽  
Patients With Diabetes

IntroductionStudies demonstrate that optimal glycaemic control reduces morbidity from diabetes mellitus but remains elusive in a significant portion of patients. Although research shows that continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) improves glycaemic control in selected subsets of patients with diabetes in specialty practices, we found no systematic reviews evaluating the use of CGM/FGM in primary care, where the majority of patients with diabetes are cared for.This systematic review aims to answer the questions: ‘compared with usual care of self-monitoring blood glucose and haemoglobin A1c (HbA1c), does the addition of CGM/FGM use in the primary care of patients with diabetes improve glycaemic control, decrease rates of hypoglycaemia, and improve patient and physician satisfaction?’ and if so, ‘what subgroups of primary care patients with diabetes are most likely to benefit?’.Methods and analysisAligning with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines, a search will be conducted in PubMed, EMBASE, Scopus, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science. We will include studies investigating CGM/FGM use and reporting the primary outcome measure of HbA1c and secondary outcome measures of hypoglycaemia, time in range, time below range, time above range and patient/staff satisfaction. We will examine which patient populations appear to benefit from CGM/FGM. Three independent researchers will use the Covidence systematic review software for blinded screening and study selection. The National Heart, Lung, and Blood Institute quality assessment tool and Grading of Recommendations Assessment, Development and Evaluation will be used to assess the risk of bias and quality of evidence.Ethics and disseminationThe systematic review methodology does not require ethics approval due to the nature of the study design. Study findings will be publicly available to a wide readership across disciplines and will be published in a peer-reviewed journal.PROSPERO registration numberCRD42021229416.

scholarly journals Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041486
Author(s):  
Agata Majewska ◽  
Paweł Stanirowski ◽  
Mirosław Wielgoś ◽  
Dorota Bomba-Opoń
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Blood Glucose Concentration ◽  
Glucose Monitoring ◽  
Flash Glucose Monitoring ◽  
Medical University ◽  
The Impact

IntroductionGestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysisThis is a prospective, randomised study, that will recruit 100 women at 24–28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and disseminationThe study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04422821.

scholarly journals Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039400
Author(s):  
Yongwen Zhou ◽  
Hongrong Deng ◽  
Hongxia Liu ◽  
Daizhi Yang ◽  
Wen Xu ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Type 1 Diabetes Mellitus ◽  
Glucose Monitoring ◽  
Adult Patients ◽  
Flash Glucose Monitoring ◽  
Distress Scale

IntroductionOptimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM .Methods and analysisThis open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0–2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12–14 weeks and 24–26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale.Ethics and disseminationThis study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.Trial registration numberNCT03522870.

scholarly journals Continuous Glucose Monitoring System Versus Self-Monitoring Blood Glucose in Type 1 Diabetes Mellitus Children: A Randomised Controlled Trial (RoSEC)

2021 ◽  
Vol 27 (2) ◽  
pp. 51-68
Author(s):  
Muhd Alwi Muhd Helmi ◽  
Norsa'adah Bachok ◽  
Suhaimi Hussain
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Monitoring System ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Control Group ◽  
Self Monitoring ◽  
The Mean

Objectives: The primary and secondary objectives were to compare the glycaemic control and frequency of hypoglycaemia between continuous glucose monitoring system (CGMS) and self-monitoring blood glucose (SMBG). Methods: A single centre, randomised, parallel-group controlled trial was conducted involving twenty-two type one Diabetes Mellitus (T1DM) patients with the mean age of 13.8 years assigned to either intervention or control group. All respondents wore the CGMS device at the beginning of the study. Intervention group (n=11) had their insulin adjusted based on the CGMS data, while the control group (n=11) was based on SMBG. Monthly average blood sugar level (BSL) and monthly mean hypoglycemic events per week (HE/wk) were measured at baseline, first month, second month, and third month. HbA1c levels were measured at baseline and in the third month. Results: The baseline characteristics were similar. The data were analysed using repeated measure analysis of variance (ANOVA). The mean difference of HbA1c within the group was not statistically significant with p=0.322. There were significant differences in the monthly mean HE/wk within and between groups, p=0.004, and p=0.037. Conclusion: In conclusion, CGMS is equivalent to SMBG in optimising glycaemic control but is more effective in detecting hypoglycaemia in children.  

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