Diabetes Mellitus, Type 1NCT03199716
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
A study testing Parent mentors in people with Diabetes Mellitus, Type 1, run by University of California, Davis at 1 site in United States.
Trial summary
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Parent mentors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 23 Mar 2017
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Residing within 60 miles of a Parent Mentor
- Child diagnosed with T1DM greater than or equal to 1 year at the start of our study's data collection (February 2015)
- On multiple daily injection regime or insulin pump therapy
- Mean HbA1c between 8.5 - 12.5% over the last 2 clinic visits
- Child diagnosed with T1DM greater than or equal to 2 years at the start of our study's data collection
- Compliant with suggestions made by the diabetes care team
- Mean HbA1c less than or equal to 8% over the last 2 clinic visits
- No episodes of diabetic ketoacidosis, aside from initial episode at diagnosis, if applicable
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Pediatrics Endocrinology
Sacramento, California, 95817
About this study
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Read the detailed description
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Parent mentors
- 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.
Parent mentorsOther
Parent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications
| Study group | Role | What they receive |
|---|---|---|
| Parent Mentors and Intervention Group | Experimental | Parent mentors are parents from our UC Davis Pediatrics Endocrinology clinic who have met our parent mentor inclusion criteria; the intervention group are families in our clinic who have met our mentee family inclusion criteria Receives: Other: Parent mentors |
| Control Group with no Parent Mentors | No intervention | The control group is made up of families at our UC Davis Pediatrics Endocrinology clinic who have met the mentee family inclusion criteria but are not matched with a parent mentor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily frequency of blood glucose monitoring (BGM)
Number of glucose monitoring events per day
Measured: up to 12 months
Secondary outcomes (1)
HbA1c levels
Values of HbA1c in blood
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startSep 2014
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
- Investigators
- Dennis Styne, MD, Principal investigator, UC Davis Pediatrics EndocrinologyYvonne Lee, MD, Principal investigator, UC Davis Pediatrics Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199716
- Sponsor's protocol ID
- 615897
- Status last verified
- Jun 2019
- First submitted
- 19 Feb 2015
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
- ClinicalTrials.gov ID
- NCT03199716
- Acronym / sponsor ID
- 615897
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Sep 2014 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 27 Jun 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.
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Detailed description
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Mentors and Intervention Group | Experimental | Other: Parent mentorsParent mentors are parents from our UC Davis Pediatrics Endocrinology clinic who have met our parent mentor inclusion criteria; the intervention group are families in our clinic who have met our mentee family inclusion criteria |
| Control Group with no Parent Mentors | No intervention | –The control group is made up of families at our UC Davis Pediatrics Endocrinology clinic who have met the mentee family inclusion criteria but are not matched with a parent mentor |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Residing within 60 miles of a Parent Mentor
- Child diagnosed with T1DM greater than or equal to 1 year at the start of our study's data collection (February 2015)
- On multiple daily injection regime or insulin pump therapy
- Mean HbA1c between 8.5 - 12.5% over the last 2 clinic visits
- Child diagnosed with T1DM greater than or equal to 2 years at the start of our study's data collection
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Parent mentorsParent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications | Other | Parent Mentors and Intervention Group |
Primary outcome
Daily frequency of blood glucose monitoring (BGM)
Time frame: up to 12 months
Number of glucose monitoring events per day
1 secondary outcome
HbA1c levels
Time frame: up to 12 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 12 Jun 2019.
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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.
Dennis Styne, MD principal investigator
UC Davis Pediatrics Endocrinology
Yvonne Lee, MD principal investigator
UC Davis Pediatrics Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent mentors in people with Diabetes Mellitus, Type 1, run by University of California, Davis 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 8 inclusion and 0 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 12 Jun 2019. 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?
Daily frequency of blood glucose monitoring (BGM) (time frame: up to 12 months). 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 12 Jun 2019.