Budget Impact Analysis of Self-Monitoring of Blood Glucose vs. Flash-Continuous Glucose Monitoring in Intensive Insulin Users with Diabetes Type 2 Covered by Medicare and Medicaid

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 142-LB
Author(s):  
MAGNUS STUEVE ◽  
YORK F. ZOELLNER
BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040648
Author(s):  
Nanna Lind ◽  
Dorte Lindqvist Hansen ◽  
Signe Sætre Rasmussen ◽  
Kirsten Nørgaard

IntroductionMedical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.Methods and analysisThe study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration numberClinicalTrials.gov Registry (NCT04331444).Protocol versionV.3, 11 December 2020.


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 913-P
Author(s):  
YUYA TAKANO ◽  
YULIA NAMIKI ◽  
HIROKO HIIRAGI ◽  
TAKU YAMADA ◽  
HIROTO SASAKI ◽  
...  

2017 ◽  
Vol 13 (02) ◽  
pp. 57 ◽  
Author(s):  
Stephen M Twigg ◽  
Mahmood R Kazemi ◽  
Maria E Craig ◽  
◽  
◽  
...  

Objective: Established methods of self-monitoring of glucose levels include capillary self-monitoring of blood glucose (SMBG) and interstitial continuous glucose monitoring (CGM). Flash CGM is a novel form of self-monitoring that provides on-demand continuous interstitial glucose profiles. The purpose of this article is to critically review the recent outcome data from randomized controlled trials that assessed the efficacy and safety of flash CGM to replace routine SMBG in diabetes management. Methods: Two recent six-month, prospective, multicenter, randomized controlled trials in type 1 (IMPACT; NCT02232698) and type 2 (REPLACE; NCT02082184) diabetes compared flash CGM with SMBG under otherwise usual care conditions. The trials did not use a prescribed treatment algorithm based on self-monitoring of glucose. Results: Both trials demonstrated that the time spent in hypoglycemia over a 24-hour period, as well as overnight, was markedly reduced by flash CGM without deterioration in glycated hemoglobin (A1C) levels. In IMPACT there was a 38% reduction in time in hypoglycemia with flash CGM versus SMBG, and in REPLACE there was a 43% reduction in time in hypoglycemia with flash CGM compared with SMBG. Moreover, patient satisfaction improved with flash CGM, usage adherence rates were high, and flash CGM was well tolerated. Conclusions: The findings from these trials suggest that improved care outcomes can be achieved when flash CGM is integrated into current established clinical care paradigms. Flash CGM provides important advantages over SMBG that are likely to be applicable to real-world care of individuals with differing forms of diabetes requiring intensive insulin treatment.


Sign in / Sign up

Export Citation Format

Share Document