NCT04932928Recruiting
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 21 Jun 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose. Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 13 Jun 2021
- Start date
- 23 Mar 2021
- Primary completion date
- 23 Sept 2022
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT04932928
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 23 Mar 2021 to the primary completion date, 23 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Addiction to drugs and alcohol
- Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
Other illness
- Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
- Change in diabetes medication in the preceding 3 months
- Severe liver disease
- End-stage renal disease (i.e. on dialysis)
- Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
Lab values
- Conditions that impact the stability of HbA1c measurement
Other
- Use of prandial insulin
- Pregnant/lactating women
Who the study is looking for
- Age 19-80
- Diagnosed with type 2 diabetes mellitus (DM)
- Uncontrolled type 2 DM: HbA1c 7.0-10.0%
- Signed informed consent
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.