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

NCT ID: NCT06117449

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-05-01

Brief Summary

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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 .

Detailed Description

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Conditions

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Diabete Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients going on insulin therapy

No interventions assigned to this group

patients going on oral antidiabetic drugs

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Ashraf Mohamed Hussein

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Esraa Ashraf

Role: CONTACT

01154727599 ext. +20

Loubna Eltony, prof

Role: CONTACT

References

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Elsner RH. California bureaucrats propose control of excess physicians. Fed Bull. 1979 May;66(5):140-1. No abstract available.

Reference Type BACKGROUND
PMID: 10241716 (View on PubMed)

Witek TJ Jr. The nose as a target for adverse effects from the environment: applying advances in nasal physiologic measurements and mechanisms. Am J Ind Med. 1993 Nov;24(5):649-57. doi: 10.1002/ajim.4700240512. No abstract available.

Reference Type BACKGROUND
PMID: 8266937 (View on PubMed)

Ishii H, Terauchi Y, Jinnouchi H, Taketsuna M, Takeuchi M, Imaoka T. Effects of insulin changes on quality of life and glycemic control in Japanese patients with type 2 diabetes mellitus: The insulin-changing study intending to gain patients' insights into insulin treatment with patient-reported health outcomes in actual clinical treatments (INSIGHTs) study. J Diabetes Investig. 2013 Nov 27;4(6):560-70. doi: 10.1111/jdi.12086. Epub 2013 Apr 30.

Reference Type BACKGROUND
PMID: 24843710 (View on PubMed)

Other Identifiers

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ESITT2DP

Identifier Type: -

Identifier Source: org_study_id

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