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Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:
Steno2tech CGM-The Effect of Real-time Continuous Glucose Monitoring vs. Self-monitoring of Blood Glucose on Glycemic Variables and Patient Reported Outcomes in Adults With Type 2 Diabetes Treated With Insulin-A Randomized Controlled Trial.

Clinical Trial Summary

The overall objective of this research study is to examine the effectiveness of the use of CGM vs. SMBG in persons with insulin-treated type 2 diabetes on glycemic variables and patient reported outcomes on treatment satisfaction, health behavior and wellbeing. The independent effect of peer-support will also be studied.

Clinical Trial Description

The prevalence of type 2 diabetes is increasing. Although medical treatment options have increased, still less than a third obtain their optimal glycemic goal. The use of continuous glucose monitoring (CGM) in persons with type 1 diabetes has shown to be the most important driver for improvement in glycemic control-even more than insulin-pump therapy-but the use of technology in type 2 diabetes are not yet reimbursed and has been investigated in very few studies. The study will be a single center, prospective, randomized, open-labelled, three-armed study with the randomization 2:1:2 in group A with CGM, group B with CGM and peer-support, group C as a control group with SMBG. The study will run for 12 months and will include 100 adult participants with insulin-treated type 2 diabetes, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Recruitment will begin in August 2020 and end in May 2022. Final 12-month follow-up is anticipated to be in July 2023. The study is investor-initiated. The primary investigator (Nanna Lind, PhD. Student) will be responsible for execution of this study under guidance by the sponsor Kirsten Nørgaard. Results will be published in international peer-reviewed journals. Our study will provide evidence of the effectiveness of the use of CGM in the treatment for type 2 diabetes, potentially shaping clinical guidelines for SMBG frequency and timing as well as use of technology in type 2 diabetes with an impact on both healthcare and healthcare costs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04331444
Study type Interventional
Source Steno Diabetes Center Copenhagen
Contact
Status Completed
Phase N/A
Start date August 1, 2020
Completion date July 1, 2023
View Details
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