A Study of Technology to Improve Glucose Control in Parti... | NCT03758430

Studies
A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes

NCT03758430

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Aug 21, 2020Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 1

Interventions

Meal-Tagging App
Fitness Tracker

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
F3Z-MC-IORA	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2019Actual

Primary Completion Date

Aug 7, 2020Actual

Completion Date

Aug 7, 2020Actual

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Nov 27, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2020

Last Update Posted Date

Aug 21, 2020Actual

Name	Class
Joslin Diabetes Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 App Device: Fitness Tracker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meal-Tagging App	Other	Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.	Combined Diabetes Management Data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)	Change from Baseline to Week 16 in HbA1c	Baseline to Week 16

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals	Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals	Baseline to Week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with T1D

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joslin Diabetes Center		Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072936	Fitness Trackers

Ancestor Terms

ID	Term
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided