Skip to main content
OpenTrials
Completed

NCT Number: NCT04516694

Promoting Adolescent Investment In Diabetes Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial incentive (gain)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. HbA1c

    Time frame: 12 weeks

    Change in HbA1c from baseline to 12 weeks

Secondary outcomes

  1. Glucose monitoring

    Time frame: 12 weeks

    Frequency of glucose monitoring

  2. Insulin Administration

    Time frame: 12 weeks

    Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant

  3. SCI-R

    Time frame: 12 weeks

    The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations

  4. PAID-T

    Time frame: 12 weeks

    Problem Areas in Diabetes- Teen version

  5. DFCS

    Time frame: 12 weeks

    Diabetes Family Conflict Scale

  6. Time in Range

    Time frame: 12 weeks

    Evaluation of percentage of time spent in goal range via continuous glucose monitor system

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Seattle Children's Hospital

Registry information

Acronym: InvesT1D

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 18, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.