Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China

Study Overview
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Brief Summary
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This is a multi-centre, cross-sectional, non-interventional study assessing blood glucose target attainment, anti-hyperglycaemic treatment pattern and the clinical characteristics in older outpatients with Type 2 Diabetes Mellitus (T2DM) in hospitals of China. This study is designed to collect information of older T2DM patients in a real life setting

Official Title
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Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China: A Nationwide Cross-sectional Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: No Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form Outpatient with confirmed T2DM (According to the American Diabetes Association criteria 2015 [R16-1532]) Age≥60 years Exclusion criteria Patients with type 1 diabetes mellitus or secondary DM Patients who are participating in any other clinical study, including any questionnaire-based study, any interventional study (including diet/counselling based intervention), or any clinical study in which any medications (including Chinese herbal medications) are administered

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatient with confirmed T2DM<br>subjects with confirmed T2DM | Drug: No Treatment<br>* No treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines. | The percentage of patients attaining blood glucose control target defined as HbA1c<7%, according to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) guidelines. | At study visit (one day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function Level of Patients Measured by Albuminuria | The renal function level of patients was measured by albuminuria into following categories - normal, micro-albuminuria, macro-albuminuria and missing data. Albuminuria was measured using either as a random spot urine sample, a 24-h urine sample, or a timed urine sample. Normal was defined as < 30 mg/g, <30 mg/24h, and < 20 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Micro-albuminuria was defined as 30 - 300 mg/g, 30 - 300 mg/24h, and 20 - 200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Macro-albuminuria was defined as >300 mg/g, >300 mg/24h, and >200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. | At study visit (one day) | 
| Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR) | The renal function level of patients was measured by estimated glomerular filtration rate (eGFR). | At study visit (one day) | 
| Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage | The renal function level of patients was measured by CKD into following categories - eGFR ≥ 60 milliLitre/minute/1.73 meter ^ 2 (mL/min/1.73m^2), eGFR < 60 mL/min/1.73m^2 and missing data. | At study visit (one day) | 
| Treatment Regimens for T2DM That Patient Are Currently Taking | The treatment regimens for T2DM that patient are currently taking. | At study visit (one day) | 
| Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications | The percentage of patients macro-vascular and micro-vascular diabetic complications. | At study visit (one day) | 
| Percentage of Patients With Hypoglycaemic Occurrence | The percentage of patients with hypoglycaemic occurrence. | At study visit (one day) | 
| Percentage of Patients With Hypoglycaemia Leading to Therapy Change | The percentage of patients with hypoglycaemia leading to therapy change. | At study visit (one day) | 
| Percentage of Patients With Anti-hypertension Therapy Usage | The percentage of patients with anti-hypertension therapy usage. | At study visit (one day) | 
| Percentage of Patients With Lipid Lowering Therapy Usage | The percentage of patients with lipid lowering therapy usage. | At study visit (one day) | 
| Percentage of Patients With Anti-platelet Therapy Usage | The percentage of patients with anti-platelet therapy usage. | At study visit (one day) | 
| Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice | The follow up duration of type 2 diabetes related risk factors was summarized using the situation of lab test including serum creatinine, uric acid, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride and total cholesterol. | At study visit (one day) |