Promoting Adolescent Investment In Diabetes Care (InvesT1D)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Financial incentive (gain); Behavioral: Financial incentive (loss)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98121
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care reflects the standard treatment currently provided to T1D patients. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits.
Experimental: Gain-framed incentive; Participants will start off with nothing at the beginning of the treatment period. For each day that participants' meet goals, value will be added to their incentive balance. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits.	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.
Experimental: Loss-framed incentive; Participants will start off at the maximum incentive balance at the beginning of the treatment period and for each day that participants' fail to meet goals, value will be subtracted from their incentive balance over the 12-week. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c from baseline to 12 weeks	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): January 8, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; adolescent; young adult; type 1 diabetes; behavioral economics; financial incentive; AYA
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1540260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No