Increasing Use of Continuous Glucose Monitors in Publicly... | NCT03297762

Studies
Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

NCT03297762

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Apr 20, 2020Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Type1diabetes

Interventions

gamification
Use of Dexcom G5

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

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment challenges

Expanded Access Info

Start Date

May 7, 2018Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Sep 25, 2017

First Submission Date that Met QC Criteria

Sep 25, 2017

First Posted Date

Sep 29, 2017Actual

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

Apr 16, 2020

Last Update Posted Date

Apr 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).

Detailed Description

The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gamification	Experimental	Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.	Behavioral: gamification Behavioral: Use of Dexcom G5
Standard care	Active Comparator	Use of continuous glucose monitor (Dexcom G5) per usual care.	Behavioral: Use of Dexcom G5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gamification	Behavioral	incentives/rewards and contact between standard visits	Gamification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CGM use	amount of time per week CGM is used	baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Hgb A1c	glycemic control as measured by Hgb A1c	baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 1 diabetes for more than 6 months
on insulin pump or multiple daily injections without plans to change modality in next 6 months
insured by CCS or Medi-Cal
receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
English or Spanish-speaking

Exclusion Criteria:

major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
current oral glucocorticoid use
prior use of a CGM system
hemoglobin A1C <7.5% or >12%
no wireless internet access

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Chang, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Children's		Stanford	California	94305	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