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

October 14, 2019 updated by: Peking Union Medical College Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day-7 or day-14 or day-28 for different groups
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
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
Time Frame: Day-14 or day-28 or day-35 for different groups
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
Time Frame: Day-14 or day-28 or day-35 for different groups
Day-14 or day-28 or day-35 for different groups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The frequency of hypoglycemia
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The time in range of goal blood glucose during follow-up
Time Frame: Day-14 or day-28 or day-35 for different groups
Day-14 or day-28 or day-35 for different groups
The frequency of pain at puncture site
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of infusion pipeline connection
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The blood glucose value of hypoglycemia
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The symptoms of hypoglycemia
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The frequency of bleeding at puncture site
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The frequency of infection at puncture site
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of needle fixation
Time Frame: Day-7 or day-14 or day-28 for different groups
Day-7 or day-14 or day-28 for different groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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