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

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ClinicalTrials.gov Identifier: NCT05163054
Recruitment Status : Not yet recruiting
First Posted : December 20, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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.

Condition or disease
Type 1 Diabetes

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : January 2032
Estimated Study Completion Date : January 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 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.

  2. Time in range (TIR) [ Time Frame: 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.

  3. Incidence of hypoglycemia [ Time Frame: 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 Outcome Measures :
  1. Comprehensive metabolic control [ Time Frame: 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).

  2. Comprehensive metabolic control [ Time Frame: Outcome evaluation at 10 years. ]
    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).

  3. Occurrence of Diabetes-related complications. [ Time Frame: 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.

  4. Progression of Diabetes-related complications. [ Time Frame: 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.

  5. Anxiety condition. [ Time Frame: 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.

  6. Anxiety condition. [ Time Frame: Outcome evaluation at 10 years. ]
    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.

  7. Depression condition. [ Time Frame: 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.

  8. Depression condition. [ Time Frame: Outcome evaluation at 10 years. ]
    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.

  9. Depression condition. [ Time Frame: Outcome evaluation at 10 years. ]
    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.

  10. Life quality. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole blood sample and urine sample


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 1 diabetes from in-patient and out-patient.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163054


Contacts
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Contact: Kun Yang, MD 86-13651315864 yangkun@bjmu.edu.cn
Contact: Jin Yang, PhD 86-15810298367 yangjin@bjmu.edu.cn

Locations
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China
Peking University Third Hospital
Beijing, China, 100191
Contact: Kun Yang, MD    86-13651315864    yangkun@bjmu.edu.cn   
Contact: Jin Yang, PhD    86-15810298367    yangjin@bjmu.edu.cn   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Jin Yang, PhD Peking University Third Hospital
Principal Investigator: Kun Yang, MD Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT05163054    
Other Study ID Numbers: M2021380
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
cohort study
type 1 diabetes
mobile
home-community-hospital
China
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases