Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control

August 31, 2021 updated by: Joslin Diabetes Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention will be three (3) months in duration and will entail use of a smart phone app for real-time data logging to identify factors causing glycemic variability, as well as use of a web-based nutrition education program. The investigators postulate that the interactive nutrition education curriculum - which will provide feedback to patients about the inter-relationship between their food intake and postprandial glucose profiles, as well as practical guidance for improvements - will lead to a change in food choices and improved post-prandial glucose control.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Individuals that satisfy all of the following conditions will be considered for participation:

  1. Must be between the ages of 25 - 75 years of age (inclusive)
  2. Type 1 diabetes diagnosis at least 1 year, treated with multiple daily injections or insulin pump.
  3. A1c 7.5-9.0%

Exclusion Criteria

  1. Current or past use of real-time CGM for more than 2 months.
  2. Pregnancy (self-reported) or planning conception in next 6 months.
  3. 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),
  4. Medical conditions or medications that would affect gastric emptying such as gastroparesis, bariatric surgery, medications such as pramlinitide, liraglutide or exenatide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - Educ Module and App
Participants in this arm to be given smartphone app ("Sugar Sleuth") and educational module.
Behavioral: Sugar Sleuth
Educational module and use of smart phone app ("Sugar Sleuth")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
area under the curve (AUC) above target (> 180 mg/dL)
Time Frame: 3 months
Amount of time spent above >180 mg/dL on CGM Freestyle Libre readings
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Investigators

  • Principal Investigator: Elena Toschi, MD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

January 22, 2021

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe