Type 1 Diabetes MellitusNCT03066284
A Qualitative Study on CSII in Children and Adolescents Having Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Dasman Diabetes Institute at 1 site in Kuwait.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 20 participants
- Where
- 1 siteKuwait
- Study dates
- 14 Mar 2016to 13 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Non-English \& non-Arabic speakers
- Presence of a learning disability
- Diagnosis of any diabetes complication before starting the CSII therapy
- Diagnosis of psychological problem
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Sharq, Kuwait City, 15462/1180
Nehad A. Taha, MSc., +96522242999 ext. 2202, nehad.taha@dasmaninstitute.org
Zahraa N. Rahme, MSc., +96522242999 ext. 2207, zahraa.rahme@dasmaninstitute.org
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Children, Adolescents, Parents, Insulin Pump Therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start14 Mar 2016
- Primary completion13 Mar 2017 (estimated)
- Study completion13 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nehad Taha, Dasman Diabetes Institute
- Investigators
- Nehad A. Taha, MSc., Principal investigator, Dasman Diabetes InstituteNaglaa I. Mesbah, MSc., Principal investigator, Dasman Diabetes InstituteZahra N. Rahme, MSc., Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066284
- Sponsor's protocol ID
- RA 2016-006
- Status last verified
- Feb 2017
- First submitted
- 23 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03066284
- Acronym / sponsor ID
- RA 2016-006
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Children, Adolescents, Parents, Insulin Pump Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 13 Mar 2017 (estimated)
- Study completion
- 13 Mar 2019 (estimated)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Non-English \& non-Arabic speakers
- Presence of a learning disability
- Diagnosis of any diabetes complication before starting the CSII therapy
- Diagnosis of psychological problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehad A. Taha, MSc. principal investigator
Dasman Diabetes Institute
Naglaa I. Mesbah, MSc. principal investigator
Dasman Diabetes Institute
Zahra N. Rahme, MSc. principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehad A. Taha, MSc. (+965-22242999 ext. 2202, nehad.taha@dasmaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of IPT on QoL of children and adolescents from their perspective and their parents' perspective (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.