Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes

May 3, 2023 updated by: Nanjing First Hospital, Nanjing Medical University
This study aims at the analysis of relevant influencing factors of glycemic control in patients with diabetes.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: day 1
the glycosylated hemoglobin level of patients
day 1
TIR
Time Frame: day 1-14
time in range observed using continuous glucose monitoring
day 1-14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBG
Time Frame: day 1-14
mean blood glucose
day 1-14
MAGE
Time Frame: day 1-14
Mean amplitude of glycemic excursion assessed by continuous glucose monitoring
day 1-14
SD
Time Frame: day 1-14
the standard deviation of mean glucose
day 1-14
Incidence of hypoglycemia
Time Frame: day 1-14
Incidence of hypoglycemia
day 1-14

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

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 (Actual)

August 1, 2013

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • KY20220124-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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