Study of the impact of the Flash Glucose Monitoring System (FGM) on glycometabolism of newly diagnosed type 2 diabetic patients

JRCT ID: jRCTs042210010

Registered date:21/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 14/10/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): After written informed consents are obtained, 60 participants would be classified randomly into 2 groups; one in which participants would be equipped with FreeStyle Libre sensors during the first 12 weeks and the other in which participants would not be equipped with FreeStyle Libre2. We measure HbA1c at baseline and every 4 weeks during the first 24 weeks, and every 8weeks thereafter. If the subsequent HbA1c level is 7% or more after the 8 weeks from the baseline or the HbA1c is 9% or more, then hypoglycemic drug therapy would be introduced.

Outcome(s)

• Primary Outcome: Drug-free period

Secondary Outcome

HbA1c, fasting blood glucose
body weight, BMI
blood pressure
total-C, HDL-C, LDL-C, TG
drugs
DTSQ (Diabetes Treatment Satisfaction Questionnaire)
IPAQ (International Physical Activity Questionnaire)
BDHQ (brief-type self-administered diet history questionnaire)
adverse events
FGM data

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diabetes patients who
1)are diagnosed type 2 diabetes mellitus
2)have HbA1c level of 7.0% or more and less than 8.0%
3)are 20 years of age or older
4) are not prescribed any hypoglycemic drug

Exclude criteria

Those who have hyperglycaemic symptoms or ketosis
Those whose anti-GAD Abs are positive
Those who have been using self-monitaring of blood glucose
THose who have preproliferative or proliferative diabetic retinopathy
Those who have severe renal failure (eGFR<30/ml/min/1.73m3)
Those who are judged by their physicians to be unsuitable for enrolling the study

Related Information

• Primary Sponsor: Arima Hiroshi
• Source(s) of Monetary Support: Abbott Diabetes Care