NCT02143440

Brief Summary

To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
Last Updated

May 21, 2014

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

May 17, 2014

Last Update Submit

May 17, 2014

Conditions

Type 2 Diabetes.

Outcome Measures

Primary Outcomes (1)

  • When the glucose level decreased to about 10 mmol/L

    72-96 hours

Study Arms (1)

Newly diagnosed type 2 patients

OTHER

The initial assessment of daily insulin dose.

Behavioral: The initial assessment of daily insulin dose.

Interventions

The initial assessment of daily insulin dose.BEHAVIORAL
Newly diagnosed type 2 patients

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital.

You may not qualify if:

  • Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2014

First Posted

May 21, 2014

Study Start

March 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 21, 2014

Record last verified: 2012-03

Locations

CN(1)