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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042210010
Enrollment
60
Registered
2021-04-21
Start date
2021-10-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus diabetes mellitus

Interventions

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

Sponsors

Arima Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Drug-free period

Secondary

MeasureTime frame
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

Contacts

Public ContactTomoko Kobayashi

Nagoya University Hospital

kobayashi.tomoko@med.nagoya-u.ac.jp+81-527442142

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026