An observational study in Type 1 Diabetes, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Peking University Third Hospital · Observational
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 500 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Peking University Third Hospital is the lead sponsor of 749 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with type 1 diabetes from in-patient and out-patient.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
HbA1c
HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested.
Time frame: 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.
Time frame: 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.
Time frame: Outcome evaluation at 10 years.
Comprehensive metabolic control
Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Time frame: Outcome evaluation at 10 years.
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).
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
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.
Time frame: Outcome evaluation at 10 years.
Start is estimated for Jun 2022; primary completion for Jan 2032, 115 months later.
Of 239 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 115 months is above that.
Counting every sponsor, half of 288 studies reached it within 27 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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