- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05163054
Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China (COOPERATIONS)
31. maj 2022 opdateret af: Peking University Third Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kun Yang, MD
- Telefonnummer: 86-13651315864
- E-mail: yangkun@bjmu.edu.cn
Undersøgelse Kontakt Backup
- Navn: Jin Yang, PhD
- Telefonnummer: 86-15810298367
- E-mail: yangjin@bjmu.edu.cn
Studiesteder
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-
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Beijing, Kina, 100191
- Peking University Third Hospital
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Kontakt:
- Kun Yang, MD
- Telefonnummer: 86-13651315864
- E-mail: yangkun@bjmu.edu.cn
-
Kontakt:
- Jin Yang, PhD
- Telefonnummer: 86-15810298367
- E-mail: yangjin@bjmu.edu.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with type 1 diabetes from in-patient and out-patient.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
HbA1c
Tidsramme: Outcome evaluation at 10 years.
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HbA1c is one of the indicators that reflects the level of blood glucose control overall.
Blood sample will be required and tested.
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Outcome evaluation at 10 years.
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Time in range (TIR)
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Incidence of hypoglycemia
Tidsramme: 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.
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Outcome evaluation at 10 years.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comprehensive metabolic control
Tidsramme: 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).
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Outcome evaluation at 10 years.
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Comprehensive metabolic control
Tidsramme: Outcome evaluation at 10 years.
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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).
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Outcome evaluation at 10 years.
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Occurrence of Diabetes-related complications.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Progression of Diabetes-related complications.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Anxiety condition.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Anxiety condition.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Depression condition.
Tidsramme: 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.
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Outcome evaluation at 10 years.
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Depression condition.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Depression condition.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Life quality.
Tidsramme: Outcome evaluation at 10 years.
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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.
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Outcome evaluation at 10 years.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jin Yang, PhD, Peking University Third Hospital
- Ledende efterforsker: Kun Yang, MD, Peking University Third Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juni 2022
Primær færdiggørelse (Forventet)
1. januar 2032
Studieafslutning (Forventet)
1. januar 2032
Datoer for studieregistrering
Først indsendt
9. november 2021
Først indsendt, der opfyldte QC-kriterier
6. december 2021
Først opslået (Faktiske)
20. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2022
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M2021380
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