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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

T1DM Health Related Quality of Life Insulin Pump

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain shams University

Cairo, Abbasia, 11517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health related quality of life

Other

Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL

Primary outcomes

Confidence in diabetes self care questionnaire (CIDS)

Time frame: 10 min

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.
socioeconomic level of the family scale

Time frame: 5 minutes

Assessment of family socioeconomic standard
MINI-KID (Mini International Neuropsychiatric Interview )

Time frame: 25 minutes

Mini International Neuropsychiatric Interview for Children and Adolescents
Evaluation of health-related quality of life (HRQL)

Time frame: 5 minutes

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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Feb 16, 2021
Registry last updated: Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed