scholarly journals Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040498
Author(s):  
Evelyn Annegret Huhn ◽  
Tina Linder ◽  
Daniel Eppel ◽  
Karen Weißhaupt ◽  
Christine Klapp ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Randomised Controlled Trial ◽  
Glucose Metabolism ◽  
Gestational Diabetes ◽  
Real Time ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Pharmacological Intervention ◽  
Randomised Controlled

IntroductionReal-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.Methods and analysisOpen-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6–8 days. The third visit will be scheduled 8–10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8–10 days.Ethics and disseminationThis study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberNCT03981328; Pre-results.

scholarly journals Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial

2021 ◽  
Vol 5 (4) ◽  
pp. 265-273 ◽  
Author(s):  
Kathryn Beardsall ◽  
Lynn Thomson ◽  
Catherine Guy ◽  
Isabel Iglesias-Platas ◽  
Mirjam M van Weissenbruch ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Real Time ◽  
Preterm Infants ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Open Label ◽  
Randomised Controlled

scholarly journals GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021435 ◽  
Author(s):  
John Furler ◽  
David Norman O’Neal ◽  
Jane Speight ◽  
Irene Blackberry ◽  
Jo-Anne Manski-Nankervis ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Absolute Difference ◽  
Randomised Controlled ◽  
Retrospective Continuous Glucose Monitoring

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.

Bei schwangeren Typ-1-Diabetikerinnen ist kontinuierliches Glukosemonitoring vorteilhaft

2017 ◽  
Vol 221 (06) ◽  
pp. 260-261
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Randomised Controlled ◽  
Typ 1 Diabetes ◽  
Kontinuierliches Glukosemonitoring

Feig DS et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet 2017; pii: S0140-6736(17)32400-5. doi:10.1016/S0140-6736(17)32400-5 Um das Risiko für maternale und fetale Komplikationen zu minimieren, sollen Typ-1-Diabetes-Patientinnen vor sowie während der Schwangerschaft auf eine optimale Blutzuckereinstellung achten. Dies gelingt jedoch nicht immer. Profitieren diese Frauen und ihre Kinder von einem kontinuierlichen Glukosemonitoring (CGM)? Ein internationales Forscherteam ist dieser Frage mithilfe einer randomisierten kontrollierten Studie nachgegangen.

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial

2019 ◽  
Vol 36 (09) ◽  
pp. 891-897 ◽  
Author(s):  
Andrew S. Lane ◽  
Malgorzata A. Mlynarczyk ◽  
Margarita de Veciana ◽  
Lauren M. Green ◽  
Dana I. Baraki ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gestational Diabetes ◽  
Real Time ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Self Monitoring ◽  
Randomized Controlled ◽  
Sensor Glucose ◽  
Monitoring Group

Objective To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes. Study Design We performed a single-institution randomized controlled trial. Patients with gestational diabetes were randomized to use either real-time or blinded continuous glucose monitoring. The primary outcome was mean sensor glucose level during the fourth week of continuous glucose monitoring use. Secondary outcomes included glycemic control and a composite of obstetric and neonatal outcomes. Results Of the 40 enrolled patients, 12 (60%) patients in the blinded continuous glucose monitoring group and 11 (55%) in the real-time continuous glucose monitoring group completed 4 weeks of monitoring and were included in the final analysis. There was no significant difference in mean sensor glucose level between the blinded continuous glucose monitoring group (98.9 ± 8.9 mg/dL) and the real-time continuous glucose monitoring group (107.5 ± 11.4 mg/dL). There were also no significant differences in the time spent in glycemic target, maternal, or neonatal outcomes. Conclusion Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.

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