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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (insulin pump) | 30 patients who are on insulin pump. |
| |
| Group B (MDI) | 30 patients who are on multiple daily injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health related quality of life | Other | Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from Ain shams pediatric and adolescent diabetes unit(PADU)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams University | Cairo | Abbasia | 11517 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35690827 | Derived | El Samahy MH, Salah NY, Abdeen MS, Falastin BRK. Psychosocial aspects of continuous subcutaneous insulin infusion in children with type 1 diabetes in Egypt; a limited resources country perspective. Diabetol Metab Syndr. 2022 Jun 11;14(1):82. doi: 10.1186/s13098-022-00853-6. |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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| D004778 |
| Environment and Public Health |