Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)

Study Overview
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Brief Summary
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This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level ) Hypothesis: Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy. Aim of the Work: To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).

Official Title
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Aspects of Diabetes Technology (Insulin Pumps) Children Perspective, a Cross - Sectional Study

Conditions
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T1DM, Health Related Quality of Life, Insulin Pump

Intervention / Treatment
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* Other: Health related quality of life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Type 1 diabetes mellitus. 2.Patients who are on insulin pumps must be for at least 3 months on them Exclusion Criteria: 1. Other types of DM e.g., T2DM, MODY. 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ….etc.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (insulin pump)<br>30 patients who are on insulin pump. | Other: Health related quality of life<br>* Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL<br>|
| Group B (MDI)<br>30 patients who are on multiple daily injection. | Other: Health related quality of life<br>* Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence in diabetes self care questionnaire (CIDS) | the CIDS scale, assessment included HbA1c, emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons. | 10 min | 
| socioeconomic level of the family scale | Assessment of family socioeconomic standard | 5 minutes | 
| MINI-KID (Mini International Neuropsychiatric Interview ) | Mini International Neuropsychiatric Interview for Children and Adolescents | 25 minutes | 
| Evaluation of health-related quality of life (HRQL) | HRQL was measured by the Peds-QL 4.0 11,22. The 23-item Peds-QL 4.0 generic core scales encompass (a) physical functioning (eight items), (b) emotional functioning (five items), (c) social functioning (five items), and (d) school functioning (five items). The physical health summary score (eight items) is the same as the physical functioning scale. To create the psychosocial health summary score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the emotional, social, and school functioning scales. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin pump, T1DM, HRQL