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Trial record 71 of 2460 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03066284
Recruitment Status : Unknown
Verified February 2017 by nehad Taha, Dasman Diabetes Institute.
Recruitment status was:  Recruiting
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
nehad Taha, Dasman Diabetes Institute

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.

Condition or disease
Type 1 Diabetes Mellitus

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Other
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
Actual Study Start Date : March 14, 2016
Estimated Primary Completion Date : March 13, 2017
Estimated Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066284


Contacts
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Contact: Nehad A. Taha, MSc. +965-22242999 ext 2202 nehad.taha@dasmaninstitute.org
Contact: Zahra N. Rahme, MSc +965-22242999 ext 2207 zahraa.rahme@dasmaninstitute.org

Locations
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Kuwait
Dasman Diabetes Institute Recruiting
Sharq, Kuwait City, Kuwait, 15462/1180
Contact: Nehad A. Taha, MSc.    +96522242999 ext 2202    nehad.taha@dasmaninstitute.org   
Contact: Zahraa N. Rahme, MSc.    +96522242999 ext 2207    zahraa.rahme@dasmaninstitute.org   
Principal Investigator: Naglaa I. Mesbah, MSc.         
Sponsors and Collaborators
Dasman Diabetes Institute
Investigators
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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

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Responsible Party: nehad Taha, Senior Diabetes Educator, Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT03066284     History of Changes
Other Study ID Numbers: RA 2016-006
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by nehad Taha, Dasman Diabetes Institute:
Children
Adolescents
Parents
Insulin Pump Therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs