Clinical trial NCT03066284: A Qualitative Study on CSII in Children and Adolescents Having Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Keywords: Children
Adolescents
Parents
Insulin Pump Therapy
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sharq
country: Kuwait
facility: Dasman Diabetes Institute
state: Kuwait City
Study officials:
affiliation: Dasman Diabetes Institute
name: Nehad A. Taha, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dasman Diabetes Institute
name: Naglaa I. Mesbah, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dasman Diabetes Institute
name: Zahra N. Rahme, MSc.
role: PRINCIPAL_INVESTIGATOR
References: