NCT05280184

Brief Summary

Our objective is to test the feasibility, acceptability, and initial efficacy of using behavioral economics incentives (BEI) in a novel, semi-automated intervention to target daily insulin BOLUS scores in adolescents with suboptimal insulin use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

February 15, 2022

Results QC Date

January 7, 2026

Last Update Submit

February 9, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in Glycated Hemoglobin- HbA1c

    proxy measure of average glycemic levels

    change in week 0 outcome at week 13

  • Change in Daily Insulin Bolus Score

    valid, objective measure of insulin use in youth with type 1 diabetes; range 0-3, higher scores reflect greater adherence to mealtime insulin use

    change in week 0 outcome at week 13

Secondary Outcomes (1)

  • Change in Glucose Time in Range (70-180 mg/dL)

    change in week 0 outcome at week 13

Study Arms (2)

Coin2Dose

EXPERIMENTAL

BEI intervention that also combines automated text message reminders to dose for insulin; will test Contingent and Non-Contingent BEI

Behavioral: Coin2Dose

Standard Care Control

NO INTERVENTION

Standard care control group; will not receive automated text message reminders to dose for insulin nor BEI for daily BOLUS scores

Interventions

Coin2DoseBEHAVIORAL

Behavioral Economics incentive intervention that also combines automated text message reminders to dose for insulin

Coin2Dose

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • adolescents between 11.0-17.0 years old and their parent/guardian;
  • adolescents have a physician confirmed diagnosis of type 1 diabetes of at least 6 months duration;
  • adolescents use an insulin pump for daily type 1 diabetes self-management;
  • adolescents evidence sub-optimal daily BOLUS scores (a mean daily BOLUS score \<2.5)

You may not qualify if:

  • adolescents who do not use an insulin pump; adolescents who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM;
  • adolescents with a comorbid chronic condition (e.g., renal disease);
  • adolescents and parents who do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nemours Children's Health

Jacksonville, Florida, 32207, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • Patton SR, Fox L, Cushing CC, McDonough R, Clements MA. Cash-Only INcentives to promote insulin DOSE engagement: A protocol paper for the pilot randomized controlled trial of COIN2DOSE. Contemp Clin Trials. 2022 Dec;123:107008. doi: 10.1016/j.cct.2022.107008. Epub 2022 Nov 14.

    PMID: 36396067DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Between June 6 and July 24, 2024, a data attribution issue occurred that affected our ability to accurately link youth participants with their insulin pump data. Data from participants impacted by this issue are not included in the current dataset.

Results Point of Contact

Title
Susana R Patton
Organization
Nemours Children's Health
susana.patton@nemours.org
9046973595

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Scientist

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 15, 2022

Study Start

January 1, 2023

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

February 11, 2026

Results First Posted

February 11, 2026

Record last verified: 2026-01

Locations

US(2)