Promoting Adolescent Investment In Diabetes Care

Type 1 Diabetes Clinical Trial

— InvesT1D  

Official title:

Promoting Adolescent Investment In Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516694
• Other study ID #: 1540260
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: January 8, 2022

Study information

• Verified date: March 2024
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

Description:

Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 8, 2022
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• >12 and =18 years old
• Diagnosed with type 1 diabetes =12 months
• Speaks English fluently
• Cognitively able to participate in incentive program and complete surveys.
• Have access to a mobile phone to receive goal-obtainment and incentive updates
• Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
• Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics

Exclusion Criteria:

• Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
• Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
• Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
• Cognitively or physically unable to participate
• Patient is unable to speak in the English language
• Patient is unable to read in the English language
• Patient is a ward of the state
• Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Financial incentive (gain)
Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal.
• Financial incentive (loss)
Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal.

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c from baseline to 12 weeks	12 weeks
Secondary	Glucose monitoring	Frequency of glucose monitoring	12 weeks
Secondary	Insulin Administration	Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant	12 weeks
Secondary	SCI-R	The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations	12 weeks
Secondary	PAID-T	Problem Areas in Diabetes- Teen version	12 weeks
Secondary	DFCS	Diabetes Family Conflict Scale	12 weeks
Secondary	Time in Range	Evaluation of percentage of time spent in goal range via continuous glucose monitor system	12 weeks