NCT03758430

Brief Summary

The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

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

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

November 27, 2018

Last Update Submit

August 20, 2020

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)

    Change from Baseline to Week 16 in HbA1c

    Baseline to Week 16

Secondary Outcomes (1)

  • Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals

    Baseline to Week 16

Study Arms (1)

Combined Diabetes Management Data

Participants with type 1 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their continuous glucose monitor and insulin pump. Combined data will be used for diabetes management.

Other: Meal-Tagging AppDevice: Fitness Tracker

Interventions

Meal-Tagging AppOTHER

Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.

Combined Diabetes Management Data
Fitness TrackerDEVICE

Fitness tracker will be worn around the clock for 16 weeks.

Combined Diabetes Management Data

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with T1D

You may qualify if:

  • T1D by clinical diagnosis for \> 3 years
  • Insulin pump use \> 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
  • Continuous Glucose Monitor (CGM) \> 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
  • HbA1c 7.0-9.5%
  • Must have iPhone (meal-tagging app has been built on iOS)
  • Personal computer for uploading of pump and CGM devices
  • Willingness to follow study protocol including tagging food data
  • Comfort speaking, reading, and writing English

You may not qualify if:

  • Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
  • Individuals planning to follow a specific diet plan for weight loss
  • Inability to consume "common meals"
  • Gastroparesis;
  • Eating disorder
  • Evidence of missed insulin meal-time insulin boluses on pump download
  • Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
  • Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
  • Alcohol abuse
  • Pre-conception, pregnancy, or lactation

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

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

February 6, 2019

Primary Completion

August 7, 2020

Study Completion

August 7, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)