A Qualitative Study on CSII in Children and Adolescents Having Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Qualitative Study on the Experiences and Expectations of Children and Adolescents Having Type 1 Diabetes Towards Insulin Pump Therapy and Its Effect on Their Quality of Life in Kuwait

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03066284
• Other study ID #: RA 2016-006
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: February 27, 2017
• Start date: March 14, 2016
• Est. completion date: March 13, 2019

Study information

• Verified date: February 2017
• Source: Dasman Diabetes Institute
• Contact: Nehad A. Taha, MSc.
• Phone: +965-22242999
• Email: nehad.taha[@]dasmaninstitute.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using qualitative method; a qualitative case study using semi-structured interviews to explore patients' experiences. Study population of insulin pump patients aged 11-18 years old will be recruited from pediatrics with T1D at Dasman Diabetes Institute; who started using CSII at least one year ago and their parents. Semi-structured interviews will be recorded and then transcribed word by word. Data analysis will be performed using an inductive thematic approach.

Description:

SPECIFIC AIMS

1. To explore the experiences of adolescents and their parents and parents ofi children with type 1 diabetes in Kuwait about the use of Insulin Pump Therapy (IPT) in the context of their quality of life.

2. To gain in-depth understanding of the perceptions of adolescents and their parents and parents of children with type 1 diabetes in Kuwait with T1DM about IPT and its use for diabetes management.

Design A qualitative case study methodology will be adopted using semi-structured interviews for data gathering. Interviews will be conducted with a purposive sample including adolescents and their parents and parents of children with type 1 diabetes in Kuwait with T1D, who are on CSII therapy at least 12 months, along with their parents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2017
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of T1 D in Kuwait as specified by their Consultant and in line with the Kuwait Clinical Guidelines diagnosis of T1D (2006) criteria

• Adolescents between the age of 11 and 18 or children between 2 and 10 years old

• Kuwaiti or expats

• Duration of CSII (Insulin Pump Therapy) at least 12 months.

• Prior to starting Insulin Pump Therapy must have been on MDI for a minimum of 12 months

• Attend the Insulin Pump clinic at DDI

Exclusion Criteria:

• Non-English & non-Arabic speakers

• Presence of a learning disability

• Diagnosis of any diabetes complication before starting the CSII therapy

• Diagnosis of psychological problem

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Sharq	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective		2 years