Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus; Gestational Diabetes Mellitus; Pancreatogenic Diabetes Mellitus; Pregestational Diabetes Mellitus; Diabetes Patients in Perioperative Period
• Intervention / Treatment: Device: Insulin pump (Microtech, Equil®)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weigang Zhao, MD; Phone Number: +86 13910054636; Email: xiehezhaoweigang@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
      • Contact: Weigang Zhao, MD; Phone Number: +86 13910054636; Email: xiehezhaoweigang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Age: 18-80 years old;
3. Patients and family members understand the research program and are willing to participate in the study and sign written informed consent.

Exclusion Criteria:

1. allergic to dressings and subcutaneous transfusion tubes;
2. allergic to insulin;
3. Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis).
4. 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.
5. 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.
6. 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;
7. Patients with mental illness and self-care ability;
8. Patients or their families could not understand the conditions and objectives of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 1 diabetes mellitus_7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Type 1 diabetes mellitus_14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Type 1 diabetes mellitus_28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Type 2 diabetes mellitus_7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Type 2 diabetes mellitus_14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Type 2 diabetes mellitus_28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Gestational diabetes mellitus_7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Gestational diabetes mellitus_14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Gestational diabetes mellitus_28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pregestational diabetes mellitus_7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pregestational diabetes mellitus_14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pregestational diabetes mellitus_28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pancreatogenic diabetes mellitus _7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pancreatogenic diabetes mellitus _14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Pancreatogenic diabetes mellitus _28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Diabetes patients in perioperative period _7-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Diabetes patients in perioperative period _14-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .
Experimental: Diabetes patients in perioperative period _28-day group; 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.	Device: Insulin pump (Microtech, Equil®); 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Insulin pump; Continuous subcutaneous insulin infusion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: Zhao insulin pump

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No