Diabetes Mellitus, Type 1NCT03761251
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
A study testing Pet Fish in people with Diabetes Mellitus, Type 1 and Adolescent Behavior, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Adolescent Behavior
- What is being tested?
- Pet Fish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 25 Sep 2019
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 10-13 years
- diagnosis of T1DM
- duration of T1DM for at least one year
- fluency in English
- two recent consecutive HbA1c values 8.0 - 13%
Who cannot join
- clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
- involvement in foster care
- dual-home living situation
- severe psychiatric disorders
- developmental delay or cognitive impairment
- current participation in another study that may impact glycemic control
- regular usage of a continuous glucose monitor
- HbA1c > 13% (because these individuals may need a more intensive intervention than this is intended to provide).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.
Read the detailed description
Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time for the deterioration of glycemic control in patients with T1DM. In particular, parental monitoring declines during early adolescence. This often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. Consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.
- Conditions
- Diabetes Mellitus, Type 1, Adolescent Behavior
- Being tested
- Pet Fish
- Medical subject headings
- Diabetes Mellitus, Type 1, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet FishBehavioural
Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:
- feed fish one pellet in the morning after waking; check and record BG reading at that time
- feed fish one pellet in the evening before dinner; check and record BG reading at that time
- feed fish one pellet at night before bedtime; check and record BG reading at that time
- every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.
Each child will also receive two books intended to supplement and enrich their pet fish experience.
| Study group | Role | What they receive |
|---|---|---|
| Pet Fish | Experimental | Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months Receives: Behavioral: Pet Fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start31 Oct 2018
- Primary completion9 Jul 2019
- Study completion25 Sep 2019
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 Texas Southwestern Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Gupta, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761251
- Sponsor's protocol ID
- 2018-0044
- Status last verified
- Sep 2019
- First submitted
- 28 Nov 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03761251
- Acronym / sponsor ID
- 2018-0044
- Conditions
- Diabetes Mellitus, Type 1, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 3 Dec 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 study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.
Detailed description
Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time for the deterioration of glycemic control in patients with T1DM. In particular, parental monitoring declines during early adolescence. This often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. Consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pet Fish | Experimental | Behavioral: Pet FishParticipants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 10-13 years
- diagnosis of T1DM
- duration of T1DM for at least one year
- fluency in English
- two recent consecutive HbA1c values 8.0 - 13%
Key exclusion criteria (8 listed)
- clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
- involvement in foster care
- dual-home living situation
- severe psychiatric disorders
- developmental delay or cognitive impairment
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 |
|---|---|---|
| Pet FishParticipants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care: 1. feed fish one pellet in the morning after waking; check and record BG reading at that time 2. feed fish one pellet in the evening before dinner; check and record BG reading at that time 3. feed fish one pellet at night before bedtime; check and record BG reading at that time 4. every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern. Each child will also receive two books intended to supplement and enrich their pet fish experience. | Behavioural | Pet Fish |
Primary outcome
Hemoglobin A1c
Time frame: 3 months
Glycated hemoglobin test provides an average level of blood sugar over the past 3 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 2 Oct 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.
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?
A study testing Pet Fish in people with Diabetes Mellitus, Type 1 and Adolescent Behavior, run by University of Texas Southwestern Medical Center 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 5 inclusion and 8 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 2 Oct 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?
Hemoglobin A1c (time frame: 3 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 2 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.