scholarly journals Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036474
Author(s):  
Anna Lilja Secher ◽  
Ulrik Pedersen-Bjergaard ◽  
Ole Lander Svendsen ◽  
Birthe Gade-Rasmussen ◽  
Thomas P Almdal ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Continuous Glucose Monitoring ◽  
Standard Care ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Carbohydrate Counting ◽  
Freestyle Libre ◽  
Randomised Controlled

IntroductionThere are beneficial effects of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM) in persons with type 1 diabetes. We aim to compare the effects of isCGM, training in carbohydrate counting with ABC and the combination of the two concepts with standard care.Methods and analysisA multi-centre randomised controlled trial with inclusion criteria: ≥18 years, type 1 diabetes ≥1 year, injection therapy, HbA1c >53 mmol/mol, whereas daily use of carbohydrate counting and/or CGM/isCGM wear are exclusion criteria. Inclusion was initiated in October 2018 and is ongoing. Eligible persons are randomised into four groups: standard care, ABC, isCGM or ABC+isCGM. Devices used are FreeStyle Libre Flash and smart phone diabetes application mySugr. Participants attend group courses according to treatment allocation with different educational contents. Participants are followed for 26 weeks with clinical visits and telephone consultations. At baseline and at study end, participants wear blinded CGM, have blood samples performed and fill in questionnaires on person-related outcomes, and at baseline also on personality traits and hypoglycaemia awareness. The primary outcome is the difference in time spent in normoglycaemia (4–10 mmol/L) at study end versus baseline between the isCGM group and the standard care group. Secondary outcomes will also be analysed. Results are expected in 2020.Ethics and disseminationRegional Scientific Ethics Committee approval (H-17040573). Results will be sought disseminated at conferences and in high impact journals.Trial registration numberClinicalTrial.gov registry (NCT03682237).

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.

scholarly journals Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 390 (10110) ◽  
pp. 2347-2359 ◽  
Author(s):  
Denice S Feig ◽  
Lois E Donovan ◽  
Rosa Corcoy ◽  
Kellie E Murphy ◽  
Stephanie A Amiel ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Continuous Glucose Monitoring ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Randomised Controlled

scholarly journals A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol

2021 ◽  
Author(s):  
Sara Styles ◽  
Ben Wheeler ◽  
Alisa Boucsein ◽  
Hamish Crocket ◽  
Michel de Lange ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Glycaemic Control ◽  
Second Generation ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Self Monitoring ◽  
Freestyle Libre ◽  
Randomised Controlled

Abstract Purpose Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control. Methods This open-label randomised controlled trial will enrol 100 children (4–13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58–110 mmol/mol [7.5–12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability. Discussion This research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

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