Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus, Type 1 Noncompliance, Patient

Keywords

Type 1 DiabetesContinuous Glucose MonitorsTelemedicineRemote MonitoringSecure TextingPoorly controlled diabetes

Outcome Measures

Primary Outcomes (1)

Change in Hemoglobin A1c From Baseline to 3 Months
Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging)
3 months

Secondary Outcomes (1)

Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
3 months

Other Outcomes (17)

Change in Quality of Life Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
3 months
Change in Self Efficacy Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
3 months
Change in Parent-child Collaboration Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
3 months
+14 more other outcomes

Interventions

Continuous Glucose MonitoringOther

Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.

Secure textingOther

A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age13 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Age between 13-18
Diagnosis of type 1 diabetes for at least six months.

Sponsors & Collaborators

DexCom, Inc.
Industrycollaborator
University of Texas Southwestern Medical Center
Otherlead

Study Sites (2)

Childrens Medical Center

Dallas, Texas, 75390, United States

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Patient Compliance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

This was a pilot study so overall number of participant enrolled and ultimately assigned to the study arm was small.

Results Point of Contact

Title: Abha Choudhary
Organization: UTexasSouthwestern

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Pediatrics

Study Record Dates

First Submitted

July 17, 2020

First Posted

September 7, 2020

Study Start

November 1, 2021

Actual (reported)

Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (17)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (17)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations