An observational study in T1DM, Health Related Quality of Life and Insulin Pump, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Ain Shams University · Observational
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).
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients from Ain shams pediatric and adolescent diabetes unit(PADU)
Exclusion Criteria:
30 patients who are on insulin pump.
Other: Health related quality of life
30 patients who are on multiple daily injection.
Other: Health related quality of life
Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL
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.
Time frame: 10 min
socioeconomic level of the family scale
Assessment of family socioeconomic standard
Time frame: 5 minutes
MINI-KID (Mini International Neuropsychiatric Interview )
Mini International Neuropsychiatric Interview for Children and Adolescents
Time frame: 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.
Time frame: 5 minutes
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University