Insulin Therapy in Type 2 Diabetic Patients: Real-life Study on Effectiveness and Satisfaction

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06117449
Collaborator
(none)
100
13

Study Details

Study Description

Brief Summary

Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both.

A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity.

Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness and Satisfaction of Insulin Therapy in Type 2 Diabetic Patients (Real Life Study)
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients going on insulin therapy

    patients going on oral antidiabetic drugs

    Outcome Measures

    Primary Outcome Measures

    1. measure blood glucose level and HbA1C [baseline]

      comparison of patients who going on insulin therapy with patient going on oral antidiabetic drugs by in blood glucose level and HbA1C between

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    -Patients with type 2 diabetes mellitus aged ≥18 years.

    • Patients going on insulin therapy versus patients going on oral antidiabetic drugs.

    • patients included if they met the following

    Criteria:
    • previous diagnosis of diabetes mellitus or on medical therapy of DM.

    • no prescription fills for a basal insulin containing product in the 1-year pre index date period; and no prescription fills for bolus insulin or mixed insulin products on index date or in the 1-year pre-index date periods.

    Exclusion Criteria:
    • Patients had type 1 diabetes mellitus.

    • Pregnant patients.

    • Incapable of completing the study questionnaires.

    • were pregnant at any time during the pre-or post-index periods; or

    • were diagnosed with any other type of diabetes during the study period, including, gestational diabetes , secondary diabetes , or other abnormal glu-cose conditions .

    • Patients who were con-comitantly participating in another trial or receiving insulin treatment for reasons other than T2DM.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Esraa Ashraf Mohamed Hussein, doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06117449
    Other Study ID Numbers:
    • ESITT2DP
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2023