Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Cli… (NCT04129424) | Clinical Trial Compass
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Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China
China180 participantsStarted 2019-12-01
Plain-language summary
Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated haemoglobin (HbA1c) level and reduced risk of severe hypoglycaemia. The best mode of CSII is a kind of programmed and individualized insulin infusion mode. But at present, the applying of insulin pump is mainly during hospitalization period in China, which is not conformed with daily living scenarios of patients. The outpatient insulin pump treatment is much closer to the real living scenarios of patients. However, lack of management experience and widely accepted formative model of insulin pump applying in clinic restricted use of insulin pumps in clinical in China. The investigators aimed to explore a safe and effective management mode of insulin pump operating to enable a wide population to have access to daily use of CSII, and to maximize the rational use of limited medical resources.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients in clinic of type 1 diabetes mellitus, type 2 diabetes mellitus, gestational/pregestational diabetes mellitus, perioperative diabetes mellitus and patients with diabetes mellitus after pancreatectomy, including those with poor blood glucose control using multiple subcutaneous insulin injections or those are willing to use insulin pump therapy;
. Age: 18-80 years old;
. Patients and family members understand the research program and are willing to participate in the study and sign written informed consent.
Exclusion criteria
. allergic to dressings and subcutaneous transfusion tubes;
. allergic to insulin;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The basal insulin dose of insulin pump at the end of the study
Timeframe: Day-7 or day-14 or day-28 for different groups
2
The preprandial insulin dose of insulin pump at the end of the study
Timeframe: Day-7 or day-14 or day-28 for different groups
3
The basal insulin dose of insulin pump at the end of the 6-day follow-up
Timeframe: Day-14 or day-28 or day-35 for different groups
4
The preprandial insulin dose of insulin pump at the end of the 6-day follow-up
Timeframe: Day-14 or day-28 or day-35 for different groups
. Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis).
. Severe chronic complications of diabetes mellitus, such as peripheral vascular lesions leading to amputation or chronic foot ulcer, end-stage renal disease, etc. who researchers thought not suitable for this study.
. Two or more times of severe hypoglycemia occured in the past year (such as consciousness disturbance and coma caused by hypoglycemia), or severe unconscious hypoglycemia.
. Patients with severe impairment of cardiac function (NYHA grade III or above), liver function (alanine aminotransferase, aspartate aminotransferase or total bilirubin higher than the upper limit of normal value 2 times or more), renal function (serum creatinine higher than the upper limit of normal value) or circulation disorder;
. Patients with mental illness and self-care ability;
. Patients or their families could not understand the conditions and objectives of this study.