Type 1 Diabetes (T1D)NCT06984133
Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes
A study testing Structured education program in people with Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus (T1DM), run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
Type 1 diabetes is becoming more common in Kuwaiti and Arab adolescents. Many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Type 1 Diabetes Mellitus (T1DM)
- What is being tested?
- Structured education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteKuwait
- Study dates
- 18 May 2025to 18 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Arab adolescents
- Males and females aged 11 to 14 years.
- Have been diagnosed with type 1 diabetes for at least 6 months.
- Wearing a continuous glucose monitor (CGM).
- Individuals and their parents must be able to join the entire duration of the study.
- Individuals and their parents must voluntarily provide consent and assent.
Who cannot join
- Presence of learning disabilities or any known psychological issues.
- Attendance at any diabetes education or carbohydrate counting programs within the six months preceding the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, Sharq, 15462
Badreya Al-Lahou, PhD, +965 22242999 ext. 2660, badreya.allahou@dasmaninstitute.org
About this study
Official title: Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
Type 1 diabetes is becoming more common in Kuwaiti and Arab adolescents. Many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life.
The goal of this clinical trial is to evaluate the effectiveness of a structured educational program on glycemic control among Arab adolescents with type 1 diabetes aged 11 to 14 years.
Read more
Participants will be randomly assigned to one of two groups. The intervention group will receive the structured education program, and the control group will continue with standard care.
All participants will undergo assessments that include:
- collecting demographic and diabetes management data
- measuring weight and height
- measuring HbA1c levels and lipid profile
- filling out questionnaires on quality of life, carbohydrate and insulin dosing knowledge, physical activity
- collecting dietary intake
- providing AGP report
Participants in the intervention group will additionally be required to:
- attend the program for 4 consecutive days, one day for parents and three days for children
- fill out 3-day food diary records during the program
- attend a refresher course after 6 months
Participants in the control group will have the opportunity to participate in the program after approximately six months.
- Being tested
- Structured education program
- Keywords
- Kuwait, Glycemic control, Type 1 diabetes, Carbohydrate counting, Arab adolescents, Structured education, Adolescents, Diabetes education program, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education programBehavioural
A structured group educational program culturally adapted from a UK model for adolescents with type 1 diabetes. The program aims to empower adolescents by providing knowledge and tools needed for effective diabetes management.
It is delivered by dietitians, diabetes educators, and a pediatric endocrinologist in small groups. The curriculum targets both caregivers and adolescents: the first day is for parents and covers diabetes basics, management of hypoglycemia and hyperglycemia, insulin dosing, sick day management, and exercise considerations. The following three days focus on adolescents and include interactive sessions on the role of food in diabetes management, the effect of different nutrients on blood glucose levels, carbohydrate sources, reading food labels, advanced carbohydrate counting, and insulin dose adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Participants will receive usual care at their treating hospitals. |
| Intervention arm | Experimental | Participants will attend a structured education program over 4 days and a refresher course after 6 months. Receives: Behavioral: Structured education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Levels
Change in HbA1c Levels from baseline to 6 months
Measured: Baseline and 6 months
Change in %Time In Range (%TIR)
Change in %TIR from baseline to 6 months
Measured: Baseline and 6 months
Secondary outcomes (4)
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores from baseline to 6 months
Measured: Baseline and 6 months
Change in Diabetes-Specific Quality of Life Scores
Change in Diabetes-Specific Quality of Life Scores from baseline to 6 months, will be assessed using the validated Arabic version of the Pediatric Quality of Life Inventory 3.0 Diabetes Module (PedsQL DM).
Measured: Baseline and 6 months
Change in Hypoglycemia Frequency
This will be assessed by:
- the percentage of time blood glucose levels are below the target range (%TBR), and b) parent-reported episodes requiring treatment such as glucagon administration.
Measured: Baseline and 6 months
Change in Diabetes-Related Hospitalizations
Frequency of hospital admissions for diabetic ketoacidosis or hypoglycemia, reported by parents, within a month prior the assessment visit.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 May 2025 (estimated)
- Primary completion18 May 2028 (estimated)
- Study completion18 May 2028 (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 (T1D)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebaa Al Ozairi, MD, Study director, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984133
- Sponsor's protocol ID
- RA HM-2025-02
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Structured Educational Program on Glycemic Control in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06984133
- Acronym / sponsor ID
- RA HM-2025-02
- Keywords
- Kuwait, Glycemic control, Type 1 diabetes, Carbohydrate counting, Arab adolescents, Structured education, Adolescents, Diabetes education program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 18 May 2025 (estimated)
- Primary completion
- 18 May 2028 (estimated)
- Study completion
- 18 May 2028 (estimated)
- First posted
- 22 May 2025 (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.
Type 1 diabetes is becoming more common in Kuwaiti and Arab adolescents. Many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life.
The goal of this clinical trial is to evaluate the effectiveness of a structured educational program on glycemic control among Arab adolescents with type 1 diabetes aged 11 to 14 years.
Participants will be randomly assigned to one of two groups. The intervention group will receive the structured education program, and the control group will continue with standard care.
All participants will undergo assessments that include:
- collecting demographic and diabetes management data
- measuring weight and height
- measuring HbA1c levels and lipid profile
- filling out questionnaires on quality of life, carbohydrate and insulin dosing knowledge, physical activity
- collecting dietary intake
- providing AGP report
Participants in the intervention group will additionally be required to:
- attend the program for 4 consecutive days, one day for parents and three days for children
- fill out 3-day food diary records during the program
- attend a refresher course after 6 months
Participants in the control group will have the opportunity to participate in the program after approximately six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Participants will receive usual care at their treating hospitals. |
| Intervention arm | Experimental | Behavioral: Structured education programParticipants will attend a structured education program over 4 days and a refresher course after 6 months. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Arab adolescents
- Males and females aged 11 to 14 years.
- Have been diagnosed with type 1 diabetes for at least 6 months.
- Wearing a continuous glucose monitor (CGM).
- Individuals and their parents must be able to join the entire duration of the study.
Key exclusion criteria (2 listed)
- Presence of learning disabilities or any known psychological issues.
- Attendance at any diabetes education or carbohydrate counting programs within the six months preceding the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured education programA structured group educational program culturally adapted from a UK model for adolescents with type 1 diabetes. The program aims to empower adolescents by providing knowledge and tools needed for effective diabetes management. It is delivered by dietitians, diabetes educators, and a pediatric endocrinologist in small groups. The curriculum targets both caregivers and adolescents: the first day is for parents and covers diabetes basics, management of hypoglycemia and hyperglycemia, insulin dosing, sick day management, and exercise considerations. The following three days focus on adolescents and include interactive sessions on the role of food in diabetes management, the effect of different nutrients on blood glucose levels, carbohydrate sources, reading food labels, advanced carbohydrate counting, and insulin dose adjustment. | Behavioural | Intervention arm |
Primary outcome
Change in HbA1c Levels
Time frame: Baseline and 6 months
Change in HbA1c Levels from baseline to 6 months
Change in %Time In Range (%TIR)
Time frame: Baseline and 6 months
Change in %TIR from baseline to 6 months
4 secondary outcomes
Change in Carbohydrate Counting and Insulin Adjustment Knowledge Scores
Time frame: Baseline and 6 months
Change in Diabetes-Specific Quality of Life Scores
Time frame: Baseline and 6 months
Change in Hypoglycemia Frequency
Time frame: Baseline and 6 months
Change in Diabetes-Related Hospitalizations
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ebaa Al Ozairi, MD study director
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education program in people with Type 1 Diabetes (T1D) and Type 1 Diabetes Mellitus (T1DM), 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 2 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Badreya Al-Lahou, PhD (+965 22242999 ext. 2660, badreya.allahou@dasmaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c Levels (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. 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 22 May 2025.