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

NCT ID: NCT02556398

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-01-22

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention - Educ Module and App

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

Group Type: EXPERIMENTAL

Sugar Sleuth

Intervention Type: BEHAVIORAL

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

Interventions

Sugar Sleuth

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Toschi, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2015-07

Identifier Type: -

Identifier Source: org_study_id