NCT02556398

Brief Summary

The project involve evaluation of a web-based nutrition education program and pilot-testing of a new smartphone app for real-time data logging to identify factors causing glycemic variability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

September 21, 2015

Last Update Submit

August 31, 2021

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • area under the curve (AUC) above target (> 180 mg/dL)

    Amount of time spent above \>180 mg/dL on CGM Freestyle Libre readings

    3 months

Study Arms (1)

Intervention - Educ Module and App

EXPERIMENTAL

Participants in this arm to be given smartphone app ("Sugar Sleuth") and educational module.

Behavioral: Sugar Sleuth

Interventions

Sugar SleuthBEHAVIORAL

Educational module and use of smart phone app ("Sugar Sleuth")

Intervention - Educ Module and App

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals that satisfy all of the following conditions will be considered for participation:
  • Must be between the ages of 25 - 75 years of age (inclusive)
  • Type 1 diabetes diagnosis at least 1 year, treated with multiple daily injections or insulin pump.
  • A1c 7.5-9.0%

You may not qualify if:

  • Current or past use of real-time CGM for more than 2 months.
  • Pregnancy (self-reported) or planning conception in next 6 months.
  • History of disordered eating, actively trying to lose weight or planning to do so, BMI \> 30 kg/m2 (to limit participation by individuals who are actively trying to lose weight),
  • Medical conditions or medications that would affect gastric emptying such as gastroparesis, bariatric surgery, medications such as pramlinitide, liraglutide or exenatide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elena Toschi, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

January 22, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)