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Clinical Trials/NCT02556398
NCT02556398CompletedNot Applicable

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

Joslin Diabetes Center1 site in 1 country35 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
area under the curve (AUC) above target (> 180 mg/dL)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
25 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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%

Exclusion Criteria

  • •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.

Arms & Interventions

Intervention - Educ Module and App

Experimental

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

Intervention: Sugar Sleuth (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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