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Type 1 DiabetesCOOPERATIONSNCT05163054

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

An observational study of Type 1 Diabetes, run by Peking University Third Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Type 1 Diabetes
How many people
500 participants
Where
1 siteChina
Study dates
Jun 2022to Jan 2032
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kun Yang, MD contact

86-13651315864

yangkun@bjmu.edu.cn

Jin Yang, PhD contact

86-15810298367

yangjin@bjmu.edu.cn

China1 site

  • Peking University Third Hospital

    Beijing, 100191

    Kun Yang, MD, 86-13651315864, yangkun@bjmu.edu.cn

    Jin Yang, PhD, 86-15810298367, yangjin@bjmu.edu.cn

Other trials in China

About this study

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.

Conditions
Type 1 Diabetes
Keywords
cohort study, type 1 diabetes, mobile, home-community-hospital, China
Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested.

    Measured: Outcome evaluation at 10 years.

  2. 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.

    Measured: Outcome evaluation at 10 years.

  3. 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.

    Measured: Outcome evaluation at 10 years.

Secondary outcomes (10)

  1. Comprehensive metabolic control

    Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP).

    Measured: Outcome evaluation at 10 years.

  2. 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).

    Measured: Outcome evaluation at 10 years.

  3. 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.

    Measured: Outcome evaluation at 10 years.

  4. 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.

    Measured: Outcome evaluation at 10 years.

  5. 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.

    Measured: Outcome evaluation at 10 years.

  6. 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.

    Measured: Outcome evaluation at 10 years.

  7. 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.

    Measured: Outcome evaluation at 10 years.

  8. 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.

    Measured: Outcome evaluation at 10 years.

  9. 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.

    Measured: Outcome evaluation at 10 years.

  10. 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.

    Measured: Outcome evaluation at 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study startJun 2022 (estimated)
  3. Primary completionJan 2032 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163054
Sponsor's protocol ID
M2021380
Acronym
COOPERATIONS
Status last verified
Oct 2021
First submitted
9 Nov 2021
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kun Yang, MD (86-13651315864, yangkun@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Outcome evaluation at 10 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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