Continuous Glucose Monitoring(CGM)-Based Remote Counseling Program for Poorly Controlled Insulin-Treated Type 2 Diabetes Mellitus(T2DM): A Randomized Controlled Trial(RCT)

Development and Effectiveness of a Remote Counseling Education Program Using Continuous Glucose Monitoring (CGM) for Type 2 Diabetes Patients with Poorly Controlled Glycemic Levels on Insulin Therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012004

Enrollment

Registered

2026-05-19

Start date

2026-07-20

Completion date

Unknown

Last updated

2026-05-25

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

Conditions

None listed

Interventions

Behavioral : The intervention in this study is a CGM-based remote counseling education program for insulin-treated patients with poorly controlled type 2 diabetes, with three groups receiving differen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Adults aged 18 years or older with type 2 diabetes who have been receiving insulin injection therapy for at least 3 months 2)Patients with poorly controlled glycemia, defined as HbA1c = 7.0% 3)Willing to use a CGM device and able to wear it continuously for at least 4 weeks 4)Possession of a smartphone (Android/iPhone) with the ability to use mobile applications, and access to a stable internet or mobile communication environment at home 5)Voluntary provision of written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1)Patients with type 1 diabetes or other specific types of diabetes 2)Patients scheduled for surgery within 1 month 3)Patients unable to wear the CGM device continuously due to allergies to skin adhesives, nickel, or other sensor site materials 4)Patients with severe complications such as heart failure, renal failure, or hepatic failure 5)Women who are pregnant or breastfeeding 6)Patients with cognitive impairment that makes it difficult to understand and follow the study procedures 7)Patients currently participating in another clinical study during the study period

Design outcomes

Primary

Measure	Time frame
Change in glycated hemoglobin (HbA1c): HbA1c (%) values are extracted from medical records at baseline and 12 weeks and compared among three groups.;CGM metrics: Time In Range (TIR), Time Below Range (TBR), Time Above Range (TAR), and Coefficient of Variation (CV) are compared between the experimental group and active control group 1 after 4 weeks of CGM wear.	—

Secondary

Measure	Time frame
Change in Self-Care of Diabetes Inventory Korean version (SCODI-K) scores: 40 items across 4 subscales (maintenance, monitoring, management, confidence), measured on a 5-point Likert scale and compared among three groups over time.;Change in Self-Care Self-Efficacy Scale Korean version (SCSES-K) scores: 10 items measured on a 5-point Likert scale and compared among three groups over time.;Change in Diabetes Knowledge Test scores: 26 items (20 general diabetes knowledge, 6 insulin-related), scored 1 point per correct answer (total 0-26), compared among three groups over time.	—

Measure

Time frame

Change in Self-Care of Diabetes Inventory Korean version (SCODI-K) scores: 40 items across 4 subscales (maintenance, monitoring, management, confidence), measured on a 5-point Likert scale and compared among three groups over time.;Change in Self-Care Self-Efficacy Scale Korean version (SCSES-K) scores: 10 items measured on a 5-point Likert scale and compared among three groups over time.;Change in Diabetes Knowledge Test scores: 26 items (20 general diabetes knowledge, 6 insulin-related), scored 1 point per correct answer (total 0-26), compared among three groups over time.

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Countries

Korea, Republic of

Contacts

Public ContactYoungjin Choi

Kyung Hee University Hospital at Gangdong

young0227@hanmail.net+82-2-440-7084

Outcome results