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 Jul 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
8 months until next milestone

Study Start

First participant enrolled

July 25, 2021

Completed
3.8 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
1.3 years until next milestone

Results Posted

Study results publicly available

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

November 16, 2020

Results QC Date

April 1, 2026

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percent Glycated Hemoglobin/6 Months

    Estimated mean change (slope) in percent glycated hemoglobin per each 6 month interval from Baseline to Month 12 were obtained from a growth curve analysis using maximum likelihood estimation to account for missing data. All randomized participants were utilized in the model (ITT analysis).

    From Baseline to Month 12

  • Change in Hba1c at 12 Months, Main Effects of Each Intervention Component

    Estimated mean change from Baseline to Month 12 were obtained from a maximum likelihood structural path model to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as the change in HbA1c at 12 months vs. baseline associated with the On level of the intervention condition relative to the Off level of the intervention condition.

    12 months, controlling for baseline

Secondary Outcomes (6)

  • Change in Percent Glycated Hemoglobin Per Day of Glucose Checking Goal Achievement

    At 12 months, controlling for baseline

  • Change in Percent Glycated Hemoglobin Per Day of Mealtime Goal Achievement

    At 12 months, controlling for baseline

  • Days Per Week Meeting Glucose Checking Goal During Intervention Period, Main Effects of Each Intervention Component

    Baseline to 6 months

  • Days Per Week Meeting Mealtime Goal During Intervention Period, Main Effects of Each Intervention Component

    Baseline to 6 months

  • Change in Percent Glycated Hemoglobin Due to Each Intervention Mediated by Days Met Glucose Checking Goal

    Baseline to 12 months

  • +1 more secondary outcomes

Study Arms (4)

Sweetgoals app

EXPERIMENTAL
Behavioral: Sweetgoals app

Sweetgoals app, incentives

EXPERIMENTAL
Behavioral: IncentivesBehavioral: Sweetgoals app

Sweetgoals app, coaching

EXPERIMENTAL
Behavioral: CoachingBehavioral: Sweetgoals app

Sweetgoals app, incentives, coaching

EXPERIMENTAL
Behavioral: CoachingBehavioral: IncentivesBehavioral: Sweetgoals app

Interventions

Sweetgoals appBEHAVIORAL

App provides weekly feedback about behavioral goals

Sweetgoals appSweetgoals app, coachingSweetgoals app, incentivesSweetgoals app, incentives, coaching
CoachingBEHAVIORAL

Web health coaching

Sweetgoals app, coachingSweetgoals app, incentives, coaching
IncentivesBEHAVIORAL

Financial incentives for meeting goals

Sweetgoals app, incentivesSweetgoals app, incentives, coaching

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 (3)

  • Yallampalli H, Plaitano EG, Stanger C. Technology readiness associated with insulin pump and automated insulin delivery system use in young adults with type 1 diabetes. J Health Psychol. 2026 Mar 29:13591053261433230. doi: 10.1177/13591053261433230. Online ahead of print.

  • 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

Results Point of Contact

Title
Catherine Stanger
Organization
Dartmouth College

Study Officials

  • Catherine Stanger, Ph.D.

    Trustees of Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Optimization study. Main effects of each intervention condition are the primary aims.
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

July 25, 2021

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

August 13, 2026

Results First Posted

August 13, 2026

Record last verified: 2026-07

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