T1DMNCT04756011
Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)
An observational study of T1DM and Health Related Quality of Life, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level ) Hypothesis: Type 1 diabetes is characterized by… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- T1DM, Health Related Quality of Life, Insulin Pump
- What is being tested?
- Health related quality of life
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 1 Feb 2021
- How long will I take part?
- 11 Months
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from Ain shams pediatric and adolescent diabetes unit(PADU)
Who may be able to join
- 1.Type 1 diabetes mellitus.
- 2.Patients who are on insulin pumps must be for at least 3 months on them
Who cannot join
- 1. Other types of DM e.g., T2DM, MODY.
- 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ….etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspects of Diabetes Technology (Insulin Pumps) Children Perspective, a Cross - Sectional Study
This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )
Hypothesis:
Read more
Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy.
Aim of the Work:
To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).
- Conditions
- T1DM, Health Related Quality of Life, Insulin Pump
- Being tested
- Health related quality of life
- Keywords
- Insulin pump, T1DM, HRQL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health related quality of lifeOther
Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL
| Study group | Role | What they receive |
|---|---|---|
| Group A (insulin pump) | 30 patients who are on insulin pump. Receives: Other: Health related quality of life | |
| Group B (MDI) | 30 patients who are on multiple daily injection. Receives: Other: Health related quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence in diabetes self care questionnaire (CIDS)
the CIDS scale, assessment included HbA1c, emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.
Measured: 10 min
socioeconomic level of the family scale
Assessment of family socioeconomic standard
Measured: 5 minutes
MINI-KID (Mini International Neuropsychiatric Interview )
Mini International Neuropsychiatric Interview for Children and Adolescents
Measured: 25 minutes
Evaluation of health-related quality of life (HRQL)
HRQL was measured by the Peds-QL 4.0 11,22. The 23-item Peds-QL 4.0 generic core scales encompass (a) physical functioning (eight items), (b) emotional functioning (five items), (c) social functioning (five items), and (d) school functioning (five items). The physical health summary score (eight items) is the same as the physical functioning scale. To create the psychosocial health summary score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the emotional, social, and school functioning scales.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Mar 2020
- Primary completion17 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T1DMStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 11 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756011
- Sponsor's protocol ID
- Health related quality of life
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Samahy MH, Salah NY, Abdeen MS, Falastin BRK. Psychosocial aspects of continuous subcutaneous insulin infusion in children with type 1 diabetes in Egypt; a limited resources country perspective. Diabetol Metab Syndr. 2022 Jun 11;14(1):82. doi: 10.1186/s13098-022-00853-6.
PubMed 35690827
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Diabetes Technology (Insulin Pumps) Children Perspective, a Cross - Sectional Study
- ClinicalTrials.gov ID
- NCT04756011
- Acronym / sponsor ID
- Health related quality of life
- Conditions
- T1DM, Health Related Quality of Life, Insulin Pump
- Keywords
- Insulin pump, T1DM, HRQL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 16 Feb 2021 (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.
This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )
Hypothesis:
Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy.
Aim of the Work:
To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 11 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (insulin pump) | – | Other: Health related quality of life30 patients who are on insulin pump. |
| Group B (MDI) | – | Other: Health related quality of life30 patients who are on multiple daily injection. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from Ain shams pediatric and adolescent diabetes unit(PADU)
Key inclusion criteria (2 listed)
- 1.Type 1 diabetes mellitus.
- 2.Patients who are on insulin pumps must be for at least 3 months on them
Key exclusion criteria (2 listed)
- 1. Other types of DM e.g., T2DM, MODY.
- 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ….etc.
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 |
|---|---|---|
| Health related quality of lifeConfidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL | Other | Group A (insulin pump), Group B (MDI) |
Primary outcome
Confidence in diabetes self care questionnaire (CIDS)
Time frame: 10 min
the CIDS scale, assessment included HbA1c, emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.
socioeconomic level of the family scale
Time frame: 5 minutes
Assessment of family socioeconomic standard
MINI-KID (Mini International Neuropsychiatric Interview )
Time frame: 25 minutes
Mini International Neuropsychiatric Interview for Children and Adolescents
Evaluation of health-related quality of life (HRQL)
Time frame: 5 minutes
HRQL was measured by the Peds-QL 4.0 11,22. The 23-item Peds-QL 4.0 generic core scales encompass (a) physical functioning (eight items), (b) emotional functioning (five items), (c) social functioning (five items), and (d) school functioning (five items). The physical health summary score (eight items) is the same as the physical functioning scale. To create the psychosocial health summary score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the emotional, social, and school functioning scales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 35690827El Samahy MH, Salah NY, Abdeen MS, Falastin BRK. Psychosocial aspects of continuous subcutaneous insulin infusion in children with type 1 diabetes in Egypt; a limited resources country perspective. Diabetol Metab Syndr. 2022 Jun 11;14(1):82. doi: 10.1186/s13098-022-00853-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 T1DM and Health Related Quality of Life, run by Ain Shams University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confidence in diabetes self care questionnaire (CIDS) (time frame: 10 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756011, which also lists 1 linked publication.
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 23 Feb 2021.