NCT04646473

Brief Summary

The study will test an app and web-delivered intervention designed to improve glycemic control (HbA1c) among young adults with Type 1 diabetes. All participants will receive the "core" digital intervention, the SweetGoals app, focused on self-monitoring and goal setting. Efficacy of two independent intervention components (incentives for adherence and web health coaching) will be tested

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

November 16, 2020

Last Update Submit

July 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Mean HbA1c

    +12 months

Secondary Outcomes (2)

  • Glucose checking adherence

    +12 months

  • Problem solving

    +12 months

Study Arms (4)

App only

EXPERIMENTAL

Sweetgoals app only

Behavioral: SweetGoals app

App plus Incentives

EXPERIMENTAL

SweetGoals app + incentives=yes + coaching=no

Behavioral: SweetGoals appBehavioral: Incentives

App plus Coaching

EXPERIMENTAL

Sweetgoals app + incentives=no + coaching=yes

Behavioral: SweetGoals appBehavioral: Coaching

App plus Coaching plus Incentives

EXPERIMENTAL

Sweetgoals app + incentives=yes + coaching=yes

Behavioral: SweetGoals appBehavioral: CoachingBehavioral: Incentives

Interventions

SweetGoals appBEHAVIORAL

App offers goal setting and feedback

App onlyApp plus CoachingApp plus Coaching plus IncentivesApp plus Incentives
CoachingBEHAVIORAL

Web health coaching

App plus CoachingApp plus Coaching plus Incentives
IncentivesBEHAVIORAL

Financial incentives for meeting goals

App plus Coaching plus IncentivesApp plus Incentives

Eligibility Criteria

Age19 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have a diagnosis of T1D for \>18 months
  • Have A1c ≥7.5%
  • Report a visit with physician managing type 1 diabetes (T1D) within the previous 6 months
  • Participants must use a glucometer or continuous glucose monitor compatible with Glooko.

You may not qualify if:

  • Pregnancy or breast feeding
  • Severe medical illness that would preclude participation (e.g., cystic fibrosis, developmental disability, severe cognitive impairment)
  • Psychiatric illness that would preclude participation
  • Diabetes diagnoses other than T1D (Type 2 Diabetes, Maturity Onset Diabetes of the Young/MODY)
  • Use of any medications known to impact glycemic control (oral or injectable corticosteroids, beta-blockers, antipsychotic medications such as risperidone).
  • A history of known hemoglobinopathy, anemia, or transfusion (which could alter the validity of HbA1c measurement)
  • Already being engaged in a psychological intervention targeting diabetes adherence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Related Publications (2)

  • Plaitano EG, Stanger C. Joint effect of nicotine use and diabetes distress on glycemic control in young adults with type 1 diabetes. J Diabetes Complications. 2025 Aug;39(8):109083. doi: 10.1016/j.jdiacomp.2025.109083. Epub 2025 May 17.

  • Stanger C, Kowatsch T, Xie H, Nahum-Shani I, Lim-Liberty F, Anderson M, Santhanam P, Kaden S, Rosenberg B. A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial. JMIR Res Protoc. 2021 Feb 23;10(2):e27109. doi: 10.2196/27109.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Fertility

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Catherine Stanger, Ph.D.

    Trustees of Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 30, 2020

Study Start

April 29, 2021

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data will be made available to other researchers and practitioners, while safeguarding the privacy of participants and protecting confidential and proprietary data and third-party intellectual property. Findings will be published as soon as they are available in relevant peer-reviewed journals that are available online, and share as requested directly to the author(s). Data requests can be made directly to the Principal Investigator with information for accessing the data on the NIDDK Data Repository.

Shared Documents
STUDY PROTOCOL
Time Frame
If the study ends and data are no longer being obtained directly from study participants by study investigators, all study data will be provided to the Repository by the end of the funding period (which may include no-cost extensions). The period of exclusive use of the entire dataset from the study will be for three years after the last study contact for collection of intervention outcomes.
Access Criteria
Data requests made directly to the Principal Investigator or through the NIDDK Data Repository

Locations