Clinical trial NCT05163054: Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China
Official title: Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes
Keywords: cohort study
type 1 diabetes
mobile
home-community-hospital
China
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes from in-patient and out-patient.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Outcome evaluation at 10 years.
measure: Time in range (TIR)
timeFrame: Outcome evaluation at 10 years.
measure: Incidence of hypoglycemia
timeFrame: Outcome evaluation at 10 years.
Secondary outcomes:
measure: Comprehensive metabolic control
timeFrame: Outcome evaluation at 10 years.
measure: Comprehensive metabolic control
timeFrame: Outcome evaluation at 10 years.
measure: Occurrence of Diabetes-related complications.
timeFrame: Outcome evaluation at 10 years.
measure: Progression of Diabetes-related complications.
timeFrame: Outcome evaluation at 10 years.
measure: Anxiety condition.
timeFrame: Outcome evaluation at 10 years.
measure: Anxiety condition.
timeFrame: Outcome evaluation at 10 years.
measure: Depression condition.
timeFrame: Outcome evaluation at 10 years.
measure: Depression condition.
timeFrame: Outcome evaluation at 10 years.
measure: Depression condition.
timeFrame: Outcome evaluation at 10 years.
measure: Life quality.
timeFrame: Outcome evaluation at 10 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Jin Yang, PhD
role: STUDY_DIRECTOR
affiliation: Peking University Third Hospital
name: Kun Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: