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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.
In this study, the investigators plan to enroll patients of different types of diabetes, including type 1 diabetes mellitus, type 2 diabetes mellitus, gestational diabetes mellitus, perioperative diabetes mellitus, pancreatogenic diabetes mellitus (after total pancreatectomy) and diabetes patients in perioperative period,each type of diabetes patients were divided into three groups according to the time (7days, 14days and 28days) reaching the target blood glucose. Those patients are educated to record blood glucose and frequency of hypoglycemia during the study period. After achieving goal blood glucose, follow-up will continue one week to evaluate whether the blood glucose reached our goal and adjust the insulin pump parameter if necessary. The investigators plan to apply continuous glucose monitoring(CGM) for each patient during follow up. The investigators aim to explore the best time to reach goal blood glucose considering frequency of hypoglycemia, economic factors, insulin pump parameters at the end of study and the final insulin pump parameters at the end of follow up. The investigators aim to enroll patients with six different types diabetes because those patients have different insulin secretion pattern, which induced to different mode of CSII. The investigators set the goal fasting blood glucose at 4-6mmol/L and the goal postprandial blood glucose at 6-8mmol/L. The blood glucose of hypoglycemia was lower than 3.9mmol/L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes mellitus_7-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Type 1 diabetes mellitus_14-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Type 1 diabetes mellitus_28-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Type 2 diabetes mellitus_7-day group | Experimental | Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Type 2 diabetes mellitus_14-day group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump (Microtech, Equil®) | Device | Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose . |
| Measure | Description | Time Frame |
|---|---|---|
| The basal insulin dose of insulin pump at the end of the study | Day-7 or day-14 or day-28 for different groups | |
| The preprandial insulin dose of insulin pump at the end of the study | Day-7 or day-14 or day-28 for different groups | |
| The basal insulin dose of insulin pump at the end of the 6-day follow-up | Day-14 or day-28 or day-35 for different groups | |
| The preprandial insulin dose of insulin pump at the end of the 6-day follow-up | Day-14 or day-28 or day-35 for different groups |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of hypoglycemia | Day-7 or day-14 or day-28 for different groups | |
| The time in range of goal blood glucose during follow-up | Day-14 or day-28 or day-35 for different groups | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weigang Zhao, MD | Contact | +86 13910054636 | xiehezhaoweigang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Experimental |
Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Type 2 diabetes mellitus_28-day group | Experimental | Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Gestational diabetes mellitus_7-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Gestational diabetes mellitus_14-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Gestational diabetes mellitus_28-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pregestational diabetes mellitus_7-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pregestational diabetes mellitus_14-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pregestational diabetes mellitus_28-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pancreatogenic diabetes mellitus _7-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pancreatogenic diabetes mellitus _14-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Pancreatogenic diabetes mellitus _28-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Diabetes patients in perioperative period _7-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Diabetes patients in perioperative period _14-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| Diabetes patients in perioperative period _28-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
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| The frequency of pain at puncture site |
| Day-7 or day-14 or day-28 for different groups |
| The frequency of errors in patency of infusion pipeline connection | Day-7 or day-14 or day-28 for different groups |
| The blood glucose value of hypoglycemia | Day-7 or day-14 or day-28 for different groups |
| The symptoms of hypoglycemia | Day-7 or day-14 or day-28 for different groups |
| The frequency of bleeding at puncture site | Day-7 or day-14 or day-28 for different groups |
| The frequency of infection at puncture site | Day-7 or day-14 or day-28 for different groups |
| The frequency of errors in patency of needle fixation | Day-7 or day-14 or day-28 for different groups |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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