An interventional study of Freestyle Libre in PreDiabetes and Diabetes Mellitus, Type 2, sponsored by Kangbuk Samsung Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 420 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Kangbuk Samsung Hospital is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with type 2 diabetes
Patients with prediabetes
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
Device: Freestyle Libre
Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
HbA1c
HbA1c assessed by blood test after 2-week use of CGM and dietary education
Time frame: 8weeks after intervention
Fasting blood glucose
Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education
Time frame: 8weeks after intervention
Lipid profiles
Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education
Time frame: 8weeks after intervention
Body weight
Body weight assessed by blood test after 2-week use of CGM and dietary education
Time frame: 8weeks after intervention
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of three parts. * total satisfaction (minimum 0, maximum 36, higher scores mean a better outcome.) * perceived hyperglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.) * perceived hypoglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)
Time frame: 8weeks after intervention
Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).
Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of five parts. * diet (values: minimum 0, maximum 28, higher scores mean a better outcome.) * exercise (minimum 0, maximum 14, higher scores mean a better outcome.) * blood sugar check-up (values: minimum 0, maximum 14, higher scores mean a better outcome.) * foot care (minimum 0, maximum 14, higher scores mean a better outcome.) * smoking (minimum 0, maximum 1, higher scores mean a worse outcome.)
Time frame: 8weeks after intervention
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 31 months is above that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Kangbuk Samsung Hospital