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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

180

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2019

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

September 20, 2019

Completed

26 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed

Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

September 20, 2019

Last Update Submit

October 14, 2019

Conditions

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

Keywords

Diabetes mellitusInsulin pumpContinuous subcutaneous insulin infusion

Outcome Measures

Primary Outcomes (4)

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 Outcomes (9)

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
+4 more secondary outcomes

Study Arms (18)

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.