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

The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Poor Glycemic Control

Detailed Description

Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of >= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether the participants have depression (Beck depression questionnaire). Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

• Study Type: Observational
• Enrollment (Actual): 266

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of education on the HbA1c changes	Educational status may have an impact on HbA1c reduction. Participants who have reached the HbA1c target are compared in terms of their educational level and those who have not.	twelve months
The effect of depression on the HbA1c changes	The Beck Depression Index will be used to compare participants who reach the HbA1c target and those who do not	twelve months
The effect of the level of physical activity on the HbA1c changes	Physical activity is graded into 4 levels. Levels will be compared in participants who reach target HbA1c level and who do not	twelve months
The effect of weight loss on the HbA1c changes	The effect of weight loss on reaching HbA1c target of 7% will be compared	twelve months

Collaborators and Investigators

• Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
• Investigators: Principal Investigator: Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: type 2 diabetes; poorly metabolic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: : Poorly controlled T2DM-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No