Type 1 Diabetes MellitisNCT06598345
Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
A study testing Routine Pet Fish Care and Collaborative Communication in people with Type 1 Diabetes Mellitis, run by Duke University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal… Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Type 1 Diabetes Mellitis
- What is being tested?
- Routine Pet Fish Care and Collaborative Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to 31 Aug 2027
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 10-13 years (inclusive)
- diagnosis of T1DM for at least one year
- fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
- utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
- current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.
Who cannot join
- clinical or laboratory characteristics suggestive of type 2 DM
- involvement in foster care
- dual-home living situation
- severe psychiatric disorders
- developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
- current participation in another study that may impact glycemic control
- HbA1c >14% (because these individuals may need a more intensive intervention than this is intended to provide)
- lack of a computer or compatible cell phone for uploading CGM or glucometer data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.
- Conditions
- Type 1 Diabetes Mellitis
- Being tested
- Routine Pet Fish Care, Collaborative Communication
- Keywords
- type 1 diabetes
- 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.
Routine Pet Fish CareBehavioural
Participants in the Routine Group will be provided specific instructions for coupling the daily and weekly fish care and diabetes care throughout the 12-week intervention They will also be told to monitor BG four times daily, review BG readings with their parent weekly and document the BG checks and weekly reviews on their device's software.
Collaborative CommunicationBehavioural
Parents and participants in the Collaborative Communication group will be given recommendations for how to conduct weekly meetings in a collaborative approach based on a modified version of the Minute Meeting protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pet Fish with Integrated Diabetes Care + Collaborative Communication | Experimental | Participants will receive specific instructions for coupling daily and weekly fish care and diabetes care throughout the 12-week intervention and how to conduct weekly collaborative communication meetings. Receives: Behavioral: Routine Pet Fish Care; Behavioral: Collaborative Communication |
| Pet Fish with Integrated Diabetes Care Only | Active comparator | Participants in the Pet Fish with Integrated Diabetes Care Only Group will be provided specific instructions for coupling the fish care and diabetes care throughout the 12-week intervention. Receives: Behavioral: Routine Pet Fish Care |
| Control | No intervention | Participants in the Control Group will be told to monitor BG (blood glucose) four times daily, review BG readings with their parent weekly and document on their device's software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be calculated as [number of participants assenting] divided by [number who were invited]
Measured: Baseline
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
Fidelity to BGM partnered with fish feeding will be assessed by calculating the percentage of BG checks that were partnered with fish feeding.
Measured: 3 months
Fidelity to weekly reviews partnered with fish tank maintenance
Fidelity to weekly reviews partnered with fish tank maintenance will be assessed by calculating the percentage of BG (blood glucose) reviews that were partnered with tank maintenance. The research team will review the data uploads on a weekly basis.
Measured: 3 months
Retention rate
Retention rate will be calculated as [number of participants who continue fish care tasks] divided by [number who were eligible upon completion of the baseline assessment].
Measured: 3 months
Secondary outcomes (5)
Number of blood glucose (BG) readings receiving parental review
Weekly BG review will be determined using the Weekly Review notations on the device's digital platform.
Measured: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
Time in Range (TIR)
Time in range (TIR) for participants using a continuous glucose monitor will be expressed as percentage of glucose readings between 70-180 mg/dL for the 2 weeks prior to the study visit per the report (i.e. Dexcom Clarity®) which is downloaded in clinic as standard of care.
Measured: Baseline, 3 months, 6 months
Self Care Inventory (SCI) (modified)
Three items from this validated measure assessing perceptions of adherence to diabetes self-care recommendations (BGM, BG review, insulin adjustment) over the previous 4 weeks will be used. Responses are on a 5-point Likert scale ranging from 0 = "Never do it" to 4 = "Always do this as recommended without fail".
Measured: Baseline, 3 months, 6 months
Blood glucose monitoring (BGM) frequency
Daily BGM frequency will be determined using the BG notations on device's digital platform. The percentage of days on which participants complete four SMBGs (self-monitoring of blood glucose) will be reported.
Measured: Baseline, 3 months, 6 months
HbA1c (Hemoglobin A1C) level
HbA1c is a biomarker that provides an estimate of glycemic control over the previous 3 months. HbA1c will be measured using a finger stick blood sample analyzed on a DCA Vantage Analyzer (Siemens). ADA recommends a goal of HbA1c <7% for this early adolescent age group.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (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 MellitisStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Olga Gupta, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598345
- Sponsor's protocol ID
- Pro00115936
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
- ClinicalTrials.gov ID
- NCT06598345
- Acronym / sponsor ID
- Pro00115936
- Conditions
- Type 1 Diabetes Mellitis
- Keywords
- type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pet Fish with Integrated Diabetes Care + Collaborative Communication | Experimental | Behavioral: Routine Pet Fish Care, Behavioral: Collaborative CommunicationParticipants will receive specific instructions for coupling daily and weekly fish care and diabetes care throughout the 12-week intervention and how to conduct weekly collaborative communication meetings. |
| Pet Fish with Integrated Diabetes Care Only | Active comparator | Behavioral: Routine Pet Fish CareParticipants in the Pet Fish with Integrated Diabetes Care Only Group will be provided specific instructions for coupling the fish care and diabetes care throughout the 12-week intervention. |
| Control | No intervention | –Participants in the Control Group will be told to monitor BG (blood glucose) four times daily, review BG readings with their parent weekly and document on their device's software. |
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 (inclusive)
- diagnosis of T1DM for at least one year
- fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
- utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
- current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.
Key exclusion criteria (8 listed)
- clinical or laboratory characteristics suggestive of type 2 DM
- involvement in foster care
- dual-home living situation
- severe psychiatric disorders
- developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
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 |
|---|---|---|
| Routine Pet Fish CareParticipants in the Routine Group will be provided specific instructions for coupling the daily and weekly fish care and diabetes care throughout the 12-week intervention They will also be told to monitor BG four times daily, review BG readings with their parent weekly and document the BG checks and weekly reviews on their device's software. | Behavioural | Pet Fish with Integrated Diabetes Care + Collaborative Communication, Pet Fish with Integrated Diabetes Care Only |
| Collaborative CommunicationParents and participants in the Collaborative Communication group will be given recommendations for how to conduct weekly meetings in a collaborative approach based on a modified version of the Minute Meeting protocol. | Behavioural | Pet Fish with Integrated Diabetes Care + Collaborative Communication |
Primary outcome
Recruitment rate
Time frame: Baseline
Recruitment rate will be calculated as [number of participants assenting] divided by [number who were invited]
Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
Time frame: 3 months
Fidelity to BGM partnered with fish feeding will be assessed by calculating the percentage of BG checks that were partnered with fish feeding.
Fidelity to weekly reviews partnered with fish tank maintenance
Time frame: 3 months
Fidelity to weekly reviews partnered with fish tank maintenance will be assessed by calculating the percentage of BG (blood glucose) reviews that were partnered with tank maintenance. The research team will review the data uploads on a weekly basis.
Retention rate
Time frame: 3 months
Retention rate will be calculated as [number of participants who continue fish care tasks] divided by [number who were eligible upon completion of the baseline assessment].
5 secondary outcomes
Number of blood glucose (BG) readings receiving parental review
Time frame: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
Time in Range (TIR)
Time frame: Baseline, 3 months, 6 months
Self Care Inventory (SCI) (modified)
Time frame: Baseline, 3 months, 6 months
Blood glucose monitoring (BGM) frequency
Time frame: Baseline, 3 months, 6 months
HbA1c (Hemoglobin A1C) level
Time frame: Baseline, 3 months, 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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Olga Gupta principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Pet Fish Care and Collaborative Communication in people with Type 1 Diabetes Mellitis, run by Duke University 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. 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?
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?
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?
Recruitment rate (time frame: Baseline). 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 9 Apr 2026.