DiabetesNCT03653013
Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?
A study testing Neuropsychological Consultation in people with Diabetes and Glycinemia, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes, Glycinemia
- What is being tested?
- Neuropsychological Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 1 Aug 2023
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
- English speaking families
Who cannot join
- not english speaking
- diagnosed with type 1 diabetes within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.
- Conditions
- Diabetes, Glycinemia
- Being tested
- Usual standard of care, Neuropsychological Consultation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual standard of careBehavioural
Also called Control Group
Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.
Neuropsychological ConsultationBehavioural
Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Usual standard of care from their diabetes care team Receives: Behavioral: Usual standard of care |
| Neuropsychological Consultation Group | Experimental | Children will be administered a number of neuropsychological tests. Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL, Generic Scale and Diabetes Module), diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module. Receives: Behavioral: Neuropsychological Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Measured: 0 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Measured: 3 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Measured: 6 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Jul 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Gallagher, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653013
- Sponsor's protocol ID
- 18-00649
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2018
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?
- ClinicalTrials.gov ID
- NCT03653013
- Acronym / sponsor ID
- 18-00649
- Conditions
- Diabetes, Glycinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Aug 2018 (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 is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Usual standard of careUsual standard of care from their diabetes care team |
| Neuropsychological Consultation Group | Experimental | Behavioral: Neuropsychological ConsultationChildren will be administered a number of neuropsychological tests. Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL, Generic Scale and Diabetes Module), diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
- English speaking families
Key exclusion criteria (2 listed)
- not english speaking
- diagnosed with type 1 diabetes within the last 6 months
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 |
|---|---|---|
| Usual standard of careAlso: Control GroupParticipants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study. | Behavioural | Control Group |
| Neuropsychological ConsultationChildren and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module. | Behavioural | Neuropsychological Consultation Group |
Primary outcome
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Time frame: 0 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Time frame: 3 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Time frame: 6 Months
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)
Time frame: 9 Months
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 24 Aug 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Mary Gallagher, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological Consultation in people with Diabetes and Glycinemia, run by NYU Langone Health at 1 site in United States.
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 24 Aug 2023. 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 United States. 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?
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C) (time frame: 0 Months). 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?
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 24 Aug 2023.