Status:
NOT_YET_RECRUITING
Precision Lifestyle Interventions Guided by Continuous Glucose Monitoring: Impact on Glycemic Outcomes in Type 2 Diabetes Mellitus
Lead Sponsor:
He Eye Hospital
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is an interventional research. Through scientific evaluation, it explores the effect of precise lifestyle intervention based on CGM data on the control of chronic type 2 diabetes mellitus. ...
Detailed Description
Internationally, significant breakthroughs have been made in diabetes research. The 'Standards of Care in Diabetes-2024' released by the ADA has shifted treatment goals from solely lowering blood gluc...
Eligibility Criteria
Inclusion
- Comply with the diagnostic criteria for T2DM in the 'Clinical guidelines for prevention and treatment of type 2 diabetes mellitus in the elderly in China (2020 edition)', and be diagnosed with type 2 diabetes mellitus, i.e., mainly due to insulin resistance and insufficient relative insulin secretion, and have the typical symptoms of diabetes mellitus (irritable thirst and excessive drinking, excessive urination, excessive food intake, and unexplained weight loss) plus a random glucose level ≥11.1 mmol/L (200 mg/dl), or plus a fasting Blood glucose level ≥ 7.0 mmol/L (126 mg/dl), or plus random blood glucose or OGTT (Oral Glucose Tolerance Test) 2-hour blood glucose level ≥ 11.1 mmol/L (200 mg/dl), or plus glycated hemoglobin (HbA1c) level ≥ 6.5%;
- Age 18～65 years old (including the threshold), gender is not limited;
- Can skillfully operate a smartphone by themselves, or their family members can help to use the phone to give feedback on their daily life situation;
- Willing to participate in this study with good compliance;
- Agree to authorize He Eye Specialist Hospital to make cases of health management content.
Exclusion
- Pregnant women, lactating women, and women of childbearing age who do not wish to use contraception during the research period;
- Severe skin disease, adhesive tape or adhesive allergy at the sensor placement site;
- People with a history of specific allergies, or allergies (e.g., allergic to two or more drugs, food, or pollen);
- Patients who meet the criteria for Grade 3 hypertension according to the ratings in the' Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revision)', i.e., blood pressure over 180/110 mmHg, or low blood pressure of 110 mmHg or more;
- Suffering from severe cardiovascular and cerebrovascular diseases (including ST-segment elevation myocardial infarction, unstable angina up to Braunwald classification III (one or more episodes of resting angina within 48 hours), transient ischemic attack, stroke treatment accompanied by various degrees of sequelae (e.g.,hemiplegia,aphasia,impaired consciousness, epilepsy, and even dementia), coronary artery stenosis of moderate stenosis (50%) and above, hemodialysis reconstruction surgery less than 6 months, cerebral embolism and cerebral hemorrhage less than 6 months or with varying degrees of movement disorders after the treatment, cognitive disorders, speech and swallowing disorders, and other sequelae, etc.), or daily accompanied by frequent episodes of angina pectoris, chest tightness, chest pain and other symptoms;
- Renal insufficiency up to stage III and above (blood creatinine level more than 450μmol/L);
- History of psychoSsis or psychotropic substance abuse;
- Any condition judged by the investigator to be unsuitable for participation.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06960512
Start Date
May 1 2025
End Date
December 1 2026
Last Update
May 7 2025
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