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

Completed

• Conditions: Insulin Pump; Health Related Quality of Life; T1DM
• Interventions: Other: Health related quality of life

• Registration Number: NCT04756011
• Lead Sponsor: Ain Shams University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-15
• Primary Completion: 2021-01-17
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-16
• Last Update Submitted: 2021-02-20
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Type 1 diabetes mellitus.
• 2.Patients who are on insulin pumps must be for at least 3 months on them

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Exclusion Criteria

• 1. Other types of DM e.g., T2DM, MODY.
• 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ....etc.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A (insulin pump)	Health related quality of life	30 patients who are on insulin pump.
Group B (MDI)	Health related quality of life	30 patients who are on multiple daily injection.

Primary Outcome Measures

Name	Time	Method
Confidence in diabetes self care questionnaire (CIDS)	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	5 minutes	Assessment of family socioeconomic standard
MINI-KID (Mini International Neuropsychiatric Interview )	25 minutes	Mini International Neuropsychiatric Interview for Children and Adolescents
Evaluation of health-related quality of life (HRQL)	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.

Trial Locations

Locations (1)

Ain shams University; 🇪🇬 Cairo, Abbasia, Egypt