NCT05854862

Brief Summary

This study aims at the analysis of relevant influencing factors of glycemic control in patients with diabetes.

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

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

August 1, 2013

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

January 1, 2023

Enrollment Period

10.4 years

First QC Date

May 3, 2023

Last Update Submit

May 3, 2023

Conditions

Glycemic Control

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    the glycosylated hemoglobin level of patients

    day 1

  • TIR

    time in range observed using continuous glucose monitoring

    day 1-14

Secondary Outcomes (4)

  • MBG

    day 1-14

  • MAGE

    day 1-14

  • SD

    day 1-14

  • Incidence of hypoglycemia

    day 1-14

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from August 2013 to the present.

You may qualify if:

  • Patients aged 18-90 years with diabetes and the diagnostic criteria of diabetes is according to the World Health Organization in 1999.

You may not qualify if:

  • Patients with stress hyperglycaemia. Patients with severe systemic disease. Patients treated with systemic glucocorticoids within the last three months. Patients without any records about HbA1c, CGM and SMBG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 11, 2023

Study Start

August 1, 2013

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-01

Locations

CN(1)