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

February 27, 2017 updated by: nehad Taha, Dasman Diabetes Institute

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kuwait
    • Kuwait City
      • Sharq, Kuwait City, Kuwait, 15462/1180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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, and were on MDI for at least 12 months before initiation of CSII

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dasman Diabetes Institute

Investigators

  • Principal Investigator: Nehad A. Taha, MSc., Dasman Diabetes Institute
  • Principal Investigator: Naglaa I. Mesbah, MSc., Dasman Diabetes Institute
  • Principal Investigator: Zahra N. Rahme, MSc., Dasman Diabetes Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Anticipated)

March 13, 2017

Study Completion (Anticipated)

March 13, 2019

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA 2016-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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