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

Health Related Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756011
• Other study ID #: Health related quality of life
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2021
• Est. primary completion date: January 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Related Quality of Life
• Insulin Pump
• T1DM

Intervention

Other:
• Health related quality of life
Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL

Locations

Country	Name	City	State
Egypt	Ain shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	socioeconomic level of the family scale	Assessment of family socioeconomic standard	5 minutes
Primary	MINI-KID (Mini International Neuropsychiatric Interview )	Mini International Neuropsychiatric Interview for Children and Adolescents	25 minutes
Primary	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