Type 2 Diabetes Mellitus
Conditions
Interventions
CGM group:Intermittent use of an open-label real-time continuous glucose monitoring (rtCGM) system.
SBGM group:Routine self-monitoring of blood glucose (SMBG).
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >18 years; 2.Type 2 diabetes mellitus (according to the 1999 WHO diagnostic criteria for diabetes), with age at diagnosis <=45 years; 3.Disease duration <=6 years; 4.HbA1c 7.0%–10.0% (inclusive) within the most recent 1 month; 5.No use of glucose-lowering medications in the past 2 months, OR use of stable-dose metformin ± SGLT2 inhibitor ± a third agent (excluding GLP-1 receptor agonists and insulin); 6.No use of real-time continuous glucose monitoring (CGM) systems in the past 3 months; 7.Ownership of a smartphone compatible with both CGM and blood glucose monitoring (BGM) systems, and willingness to use the glucometer provided by the study; able to understand the study protocol, willingness and capability to provide written informed consent, and compliance with study requirements;
Exclusion criteria
Exclusion criteria: 1.Patients with type 1 diabetes mellitus, gestational diabetes mellitus, specific types of diabetes, or secondary diabetes; 2.Use of GLP-1 receptor agonists (GLP-1 RAs) or insulin within 2 months prior to enrollment; 3.Presence of severe complications or cardiovascular disease; 4.Current use or anticipated use of oral corticosteroid therapy during the study period; 5.Severe hepatic impairment (ALT or AST levels >= 3 times the upper limit of normal); 6.Severe renal impairment or end-stage renal disease (eGFR < 30 mL/min/1.73 m^2); 7.Severe skin conditions at the sensor insertion site, or allergy to tapes or adhesives; 8.Severe psychiatric disorders precluding cooperation; 9.Pregnant or lactating women, or women of childbearing potential unwilling to use contraception during the study; 10.Use of a CGM device at screening or within the previous 3 months;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Blood proteomics and metabonomics;Gut microbiome;Urine proteomics and metabonomics;Glycemic Control Rate;CGM Metrics;Cardiovascular Disease Risk Factors;Percentage of participants achieving TIR >=70%; | — |
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Countries
China
Contacts
Public ContactYu Miao
Peking Union Medical College Hospital
Outcome results
None listed