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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556398
• Other study ID #: 2015-07
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 22, 2021

Study information

• Verified date: August 2021
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 22, 2021
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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