Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1, Adolescent Behavior

Intervention / Treatment
-----------------
* Behavioral: Pet Fish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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% Exclusion Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pet Fish<br>Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months | Behavioral: Pet Fish<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Glycated hemoglobin test provides an average level of blood sugar over the past 3 months. | 3 months |