NCT05163054

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Jun 2022Jan 2032

First Submitted

Initial submission to the registry

November 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

June 1, 2022

Status Verified

October 1, 2021

Enrollment Period

9.6 years

First QC Date

November 9, 2021

Last Update Submit

May 31, 2022

Conditions

Type 1 Diabetes

Keywords

cohort studytype 1 diabetesmobilehome-community-hospitalChina

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (10)

  • Comprehensive metabolic control

    Outcome evaluation at 10 years.

  • Comprehensive metabolic control

    Outcome evaluation at 10 years.

  • Occurrence of Diabetes-related complications.

    Outcome evaluation at 10 years.

  • Progression of Diabetes-related complications.

    Outcome evaluation at 10 years.

  • Anxiety condition.

    Outcome evaluation at 10 years.

  • +5 more secondary outcomes

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 1 diabetes from in-patient and out-patient.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample and urine sample

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jin Yang, PhD

    Peking University Third Hospital

    STUDY DIRECTOR

  • Kun Yang, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Yang, MD

CONTACT

86-13651315864yangkun@bjmu.edu.cn

Jin Yang, PhD

CONTACT

86-15810298367yangjin@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

December 20, 2021

Study Start

June 1, 2022

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Last Updated

June 1, 2022

Record last verified: 2021-10

Locations

CN(1)