NCT04932928

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

June 21, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

June 13, 2021

Last Update Submit

June 13, 2021

Conditions

Diabetes Mellitus, Type 2Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3

    Baseline to Month 3

Secondary Outcomes (6)

  • Change in mean fasting glucose

    Baseline to Month 3

  • Change in body weight

    Baseline to Month 3

  • Change in blood pressure

    Baseline to Month 3

  • Change in waist circumference

    Baseline to Month 3

  • Change in lipid level

    Baseline to Month 3

  • +1 more secondary outcomes

Other Outcomes (4)

  • Change in CGM time in target range

    Baseline to Month 3

  • Change in CGM time-hyperglycemic

    Baseline to Month 3

  • Change in CGM time-hypoglycemic

    Baseline to Month 3

  • +1 more other outcomes

Study Arms (2)

FreeStyle Libre (CGM) Group

EXPERIMENTAL

Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification

Device: FreeStyle Libre

Self Monitoring of Blood Glucose (SMBG) Group

ACTIVE COMPARATOR

Device: Blood glucose meter Education on lifestyle modification

Device: Blood glucose meter

Interventions

FreeStyle LibreDEVICE

Flash glucose monitoring + Education on lifestyle modification

Also known as: Education on lifestyle modification
FreeStyle Libre (CGM) Group
Blood glucose meterDEVICE

Self monitoring of blood glucose + Education on lifestyle modification

Also known as: Education on lifestyle modification
Self Monitoring of Blood Glucose (SMBG) Group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19-80
  • Diagnosed with type 2 diabetes mellitus (DM)
  • Uncontrolled type 2 DM: HbA1c 7.0-10.0%
  • Signed informed consent

You may not qualify if:

  • Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
  • Use of prandial insulin
  • Change in diabetes medication in the preceding 3 months
  • Pregnant/lactating women
  • Addiction to drugs and alcohol
  • Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
  • 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.)
  • Conditions that impact the stability of HbA1c measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

  • Choe HJ, Rhee EJ, Won JC, Park KS, Lee WY, Cho YM. Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study. Diabetes Care. 2022 Oct 1;45(10):2224-2230. doi: 10.2337/dc22-0764.

    PMID: 35984640DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Young Min Cho, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hun Jee Choe, MD

CONTACT

82-2-2072-1965hunjeechoe@snu.ac.kr

Young Min Cho, MD, PhD

CONTACT

82-2-2072-1965ymchomd@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 21, 2021

Study Start

March 23, 2021

Primary Completion

September 23, 2022

Study Completion

March 23, 2023

Last Updated

June 21, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)