A Qualitative Study on CSII in Children and Adolescents H... | NCT03066284

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

NCT03066284

Sponsor

Dasman Diabetes Institute

Status

Unknown status

Last Update Posted

Feb 28, 2017Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

Not provided

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2016Actual

Primary Completion Date

Mar 13, 2017Estimated

Completion Date

Mar 13, 2019Estimated

First Submitted Date

Feb 23, 2017

First Submission Date that Met QC Criteria

Feb 27, 2017

First Posted Date

Feb 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2017

Last Update Posted Date

Feb 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nehad A. Taha, MSc.	Contact	+965-22242999	2202	nehad.taha@dasmaninstitute.org
Zahra N. Rahme, MSc	Contact	+965-22242999	2207	zahraa.rahme@dasmaninstitute.org

Overall Officials

Name	Affiliation	Role
Nehad A. Taha, MSc.	Dasman Diabetes Institute	Principal Investigator
Naglaa I. Mesbah, MSc.	Dasman Diabetes Institute	Principal Investigator
Zahra N. Rahme, MSc.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dasman Diabetes Institute	Recruiting	Sharq	Kuwait City	15462/1180	Kuwait

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided