Type 1 Diabetes
Conditions
Keywords
cohort study, type 1 diabetes, mobile, home-community-hospital, China
Brief summary
For last decade, the innovation of mobile health platform has brought new opportunities for disease management. Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients. Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 12 years old; * Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999; * Be able to use smart mobile phones; * Informed consent and voluntary participation.
Exclusion criteria
* Secondary diabetes; * Complicated with malignant diseases, such as cancer, hepatic and renal failure; * Complicated with cognitive impairment or mental illness; * Be pregnant or lactating at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Outcome evaluation at 10 years. | HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested. |
| Time in range (TIR) | Outcome evaluation at 10 years. | TIR is one of the indicators that reflects the level of blood glucose control from the point of view of target time. Continuous glucose monitoring (CGM) devices will be used. |
| Incidence of hypoglycemia | Outcome evaluation at 10 years. | Incidence of hypoglycemia is one of the indicators that reflects the level of blood glucose control. Hypoglycemia is defined as blood glucose lower than 3.9mmol/L with or without symptoms. Incidence of hypoglycemia is occurence times per month according to patients self-reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety condition. | Outcome evaluation at 10 years. | Anxiety condition is one of the psychosocial status indicators, and Self-Rating Anxiety Scale (SAS) will be used to assess anxiety level. The score ranges from 20 to 100, and higher score indicates more prone to anxiety. |
| Comprehensive metabolic control | Outcome evaluation at 10 years. | Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP). |
| Life quality. | Outcome evaluation at 10 years. | Life quality is one of the psychosocial status indicators, and specific scales as World Health Organization-5 well-being index (WHO-5) will be used to assess this factor. A score \<50 indicates poor psychological well-being. |
| Depression condition. | Outcome evaluation at 10 years. | Depression condition is one of the psychosocial status indicators, and Self-Rating Depression Scale (SDS) will be used to assess depression level. The level of depression is measured by depression severity index. The index ranges from 0.25 to 1.0, with higher scores associated with greater depression. |
| Occurrence of Diabetes-related complications. | Outcome evaluation at 10 years. | To observe and analyze occurrence of diabetes-related acute and chronic complications. Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS). Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA). Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death. |
| Progression of Diabetes-related complications. | Outcome evaluation at 10 years. | To observe and analyze progression of diabetes-related acute and chronic complications. Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS). Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA). Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death. |
Countries
China
Contacts
Primary ContactKun Yang, MD
Backup ContactJin Yang, PhD
Outcome results
None listed