NCT05150041

The Efficacy of Guardian Connect to Modify Lifestyle in Patients With Type 2 Diabetes Mellitus

A Pilot Study for the Efficacy of Guardian Connect to Modify Lifestyle in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

It has been demonstrated by many different researches that for patients to work on their lifestyle modifications, it is important that the patients know their exact blood glucose levels. Unlike the HbA1c which can only be determined at the hospital, improvements in blood glucose levels were detected in both the Type 1 Diabetes Mellitus patients who use insulin as well as Type 2 Diabetes Mellitus patients with SMBG(self-monitoring of blood glucose) which is the method used by patients to measure the blood glucose level at home on their own. Where SMBG needed blood to be collected from the fingertips, it has now passed the continuous glucose monitoring(CGM) stage where blood drawing is no longer required and is now replaced by the real-time CGM(RT-CGM) where blood glucose level can be checked real time. Type 2 Diabetes Mellitus patients who do not use preprandial rapid insulin were divided into SMBG group and intermittent RT-CGM user group and their blood glucose level decrease monitored for 3 months. After 3 months, HbA1c in SMBG group decreased 0.5% compared to the baseline while 1.0% decreased in RT-CGM group. The research was extended 40 weeks to make the total research period to 52 weeks and the results still showed that there were significant decrease in the RT-CGM group. However, up to this day, there are no researches that can show that there are additional decrease in the blood glucose level in Type 2 Diabetes Mellitus patients with use of RT-CGM in the group where sufficient blood glucose management cannot be achieved through use of three oral drug combination therapy to lower the blood glucose level. This research seeks to find out if there are any decreases in the blood glucose level by using RT-CGM at 6 month period in Type 2 Diabetes Mellitu patient group whose blood glucose level cannot significantly be managed after the three oral hypoglycemic agent combination therapy.

Detailed description

* Pilot, Prospective, open label, multicenter, 3 arm, randomized, feasibility study * Divided into below three groups iPRo2 only (Control group) / iPRo2 + RT-CGM 1 week treatment (Treatment group 1) / iPRo2 + RT-CGM 1 week on /3 weeks off (2 cycles) (Treatment group 2)

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Guardian connect	* Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period. * Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.
DEVICE	iPro2	* Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period. * Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.

Timeline

• Start date: 2020-04-07
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2021-12-08
• Last updated: 2022-03-08

Locations

1 site across 1 country: South Korea