Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

NCT06385899 | Completed DMC

• 1 other identifier: : Poorly controlled T2DM-12
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months.

Conditions

Type 2 Diabetes; Poor Glycemic Control

Keywords

type 2 diabetes; poorly metabolic control

Outcome Measures

Primary Outcomes (2)

• Changes in HbA1c levels after 12 months treatment

  Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.

  twelve months

• percentage of patients who reached the HbA1c target of equal to or below 7%

  Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%

  twelve months

Secondary Outcomes (4)

• The effect of education on the HbA1c changes

  twelve months

• The effect of depression on the HbA1c changes

  twelve months

• The effect of the level of physical activity on the HbA1c changes

  twelve months

• The effect of weight loss on the HbA1c changes

  twelve months

Study Arms (4)

Newly diagnosed diabetes

Patients who have been diagnosed with type 2 diabetes within a month

Had controlled diabetes before

Patients who had at least two HbA1c levels =\<%7,5 before enrollment

Had moderately uncontrolled diabetes

Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment

Had poorly controlled diabetes

Patients who had at least two HbA1c levels above %9,5 before enrollment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed

You may qualify if:

• diagnosed with type 2 diabetes
• give consent to the study
• accessibility to the previous and recent test results

You may not qualify if:

• acute infection or inflammation lasting more than a week
• acute metabolic decompensation
• unable to attend to the follow-ups
• having non-thyroid endocrine diseases
• active oncologic treatment

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ayse N Erbakan

  Goztepe Prof Dr Suleyman Yalcın City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 26, 2024
• Study Start: August 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)