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

Primary Purpose

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Insulin pump (Microtech, Equil®)

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes mellitus, Insulin pump, Continuous subcutaneous insulin infusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
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.

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Arm Label

Type 1 diabetes mellitus_7-day group

Type 1 diabetes mellitus_14-day group

Type 1 diabetes mellitus_28-day group

Type 2 diabetes mellitus_7-day group

Type 2 diabetes mellitus_14-day group

Type 2 diabetes mellitus_28-day group

Gestational diabetes mellitus_7-day group

Gestational diabetes mellitus_14-day group

Gestational diabetes mellitus_28-day group

Pregestational diabetes mellitus_7-day group

Pregestational diabetes mellitus_14-day group

Pregestational diabetes mellitus_28-day group

Pancreatogenic diabetes mellitus _7-day group

Pancreatogenic diabetes mellitus _14-day group

Pancreatogenic diabetes mellitus _28-day group

Diabetes patients in perioperative period _7-day group

Diabetes patients in perioperative period _14-day group

Diabetes patients in perioperative period _28-day group

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The basal insulin dose of insulin pump at the end of the study

The preprandial insulin dose of insulin pump at the end of the study

The basal insulin dose of insulin pump at the end of the 6-day follow-up

The preprandial insulin dose of insulin pump at the end of the 6-day follow-up

Secondary Outcome Measures

The frequency of hypoglycemia

The time in range of goal blood glucose during follow-up

The frequency of pain at puncture site

The frequency of errors in patency of infusion pipeline connection

The blood glucose value of hypoglycemia

The symptoms of hypoglycemia

The frequency of bleeding at puncture site

The frequency of infection at puncture site

The frequency of errors in patency of needle fixation

Full Information

NCT ID

NCT04129424

First Posted

September 20, 2019

Last Updated

October 14, 2019

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04129424

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes Mellitus, Pancreatogenic Diabetes Mellitus, Pregestational Diabetes Mellitus, Diabetes Patients in Perioperative Period

Keywords

Diabetes mellitus, Insulin pump, Continuous subcutaneous insulin infusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Type 1 diabetes mellitus_7-day group

Arm Type

Experimental

Arm Description

Arm Title

Type 1 diabetes mellitus_14-day group

Arm Type

Experimental

Arm Description

Arm Title

Type 1 diabetes mellitus_28-day group

Arm Type

Experimental

Arm Description

Arm Title

Type 2 diabetes mellitus_7-day group

Arm Type

Experimental

Arm Description

Arm Title

Type 2 diabetes mellitus_14-day group

Arm Type

Experimental

Arm Description

Arm Title

Type 2 diabetes mellitus_28-day group

Arm Type

Experimental

Arm Description

Arm Title

Gestational diabetes mellitus_7-day group

Arm Type

Experimental

Arm Description

Arm Title

Gestational diabetes mellitus_14-day group

Arm Type

Experimental

Arm Description

Arm Title

Gestational diabetes mellitus_28-day group

Arm Type

Experimental

Arm Description

Arm Title

Pregestational diabetes mellitus_7-day group

Arm Type

Experimental

Arm Description

Arm Title

Pregestational diabetes mellitus_14-day group

Arm Type

Experimental

Arm Description

Arm Title

Pregestational diabetes mellitus_28-day group

Arm Type

Experimental

Arm Description

Arm Title

Pancreatogenic diabetes mellitus _7-day group

Arm Type

Experimental

Arm Description

Arm Title

Pancreatogenic diabetes mellitus _14-day group

Arm Type

Experimental

Arm Description

Arm Title

Pancreatogenic diabetes mellitus _28-day group

Arm Type

Experimental

Arm Description

Arm Title

Diabetes patients in perioperative period _7-day group

Arm Type

Experimental

Arm Description

Arm Title

Diabetes patients in perioperative period _14-day group

Arm Type

Experimental

Arm Description

Arm Title

Diabetes patients in perioperative period _28-day group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Insulin pump (Microtech, Equil®)

Intervention Description

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 .

Primary Outcome Measure Information:

Title

The basal insulin dose of insulin pump at the end of the study

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The preprandial insulin dose of insulin pump at the end of the study

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The basal insulin dose of insulin pump at the end of the 6-day follow-up

Time Frame

Day-14 or day-28 or day-35 for different groups

Title

The preprandial insulin dose of insulin pump at the end of the 6-day follow-up

Time Frame

Day-14 or day-28 or day-35 for different groups

Secondary Outcome Measure Information:

Title

The frequency of hypoglycemia

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The time in range of goal blood glucose during follow-up

Time Frame

Day-14 or day-28 or day-35 for different groups

Title

The frequency of pain at puncture site

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The frequency of errors in patency of infusion pipeline connection

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The blood glucose value of hypoglycemia

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The symptoms of hypoglycemia

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The frequency of bleeding at puncture site

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The frequency of infection at puncture site

Time Frame

Day-7 or day-14 or day-28 for different groups

Title

The frequency of errors in patency of needle fixation

Time Frame

Day-7 or day-14 or day-28 for different groups

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weigang Zhao, MD

Phone

+86 13910054636

xiehezhaoweigang@163.com

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weigang Zhao, MD

Phone

+86 13910054636

xiehezhaoweigang@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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