Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China

Type 1 Diabetes Clinical Trial

— COOPERATIONS  

Official title:

Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05163054
• Other study ID #: M2021380
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: January 2032

Study information

• Verified date: October 2021
• Source: Peking University Third Hospital
• Contact: Kun Yang, MD
• Phone: 86-13651315864
• Email: yangkun[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested.	Outcome evaluation at 10 years.
Primary	Time in range (TIR)	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.	Outcome evaluation at 10 years.
Primary	Incidence of hypoglycemia	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.	Outcome evaluation at 10 years.
Secondary	Comprehensive metabolic control	Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP).	Outcome evaluation at 10 years.
Secondary	Comprehensive metabolic control	Blood lipid is one of the control level of comprehensive metabolic indicators, including total cholesterol (TC), total triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C).	Outcome evaluation at 10 years.
Secondary	Occurrence of Diabetes-related complications.	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.	Outcome evaluation at 10 years.
Secondary	Progression of Diabetes-related complications.	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.	Outcome evaluation at 10 years.
Secondary	Anxiety condition.	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.	Outcome evaluation at 10 years.
Secondary	Anxiety condition.	Anxiety condition is one of the psychosocial status indicators. Generalized Anxiety Disorder 7-Item Scale (GAD-7 scale) will be used to assess anxiety symptoms. The score ranges from 0 to 7, and higher score indicates more anxiety symptoms.	Outcome evaluation at 10 years.
Secondary	Depression condition.	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.	Outcome evaluation at 10 years.
Secondary	Depression condition.	Depression condition is one of the psychosocial status indicators, and Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression level. The score ranges from 0 to 27. A higher score indicates a higher degree of depression.	Outcome evaluation at 10 years.
Secondary	Depression condition.	Depression condition is one of the psychosocial status indicators, and Problem Areas in Diabetes-Short form (PAID-5) will be used to evaluate the diabetes related emotional distress, which is strongly association with depression. A score =40 indicates high diabetes-related distress.	Outcome evaluation at 10 years.
Secondary	Life quality.	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.	Outcome evaluation at 10 years.