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

Ain Shams University

Status: Completed

Conditions: Insulin Pump; T1DM; Health Related Quality of Life

Treatments: Other: Health related quality of life

Study type: Observational

Funder types: Other

Identifiers

NCT04756011

Health related quality of life

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Group A (insulin pump)

Description:

30 patients who are on insulin pump.

Treatment:

Other: Health related quality of life

Group B (MDI)

Description:

30 patients who are on multiple daily injection.

Treatment:

Other: Health related quality of life