Telemedicine for Adolescents With Insulin-dependent Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Control; Other: Telemedicine

• Registration Number: NCT02155855
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

Investigators hope that providing patients and families with additional ways of communication with the diabetes care team will improve diabetes control.

Detailed Description

Study Group Study group will be asked to test blood glucose at least 4 times a day Each time the study subject takes a meter reading the meter time-stamps the reading. All meter readings will upload to the cloud via" Myglucohealth" website, where they can be accessed by caregivers, including providers and parents. Device will be programmed to coax patients when readings are due. Parents will be notified by device about the blood glucose testing results. Provider will set device to alert patient or patient's family if patient has not yet tested or uploaded a test or send alerts to parent if uploaded numbers are outside an identified range (\<70 mg/dL \> 300 mg/dL). As per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. Parents will be encouraged to contact study personnel if they are concerned about the diabetes control. Study personnel will access home blood glucose monitor data, and provide insulin dosing advice. Parents will be asked to upload blood glucose readings prior to each visit.

Control group Subjects will continue routine care which requires blood glucose testing at least 4 times a day. Parents will use customary ways to communicate (pager, email, fax or phone) with the Diabetes team, if they are concerned about glycemic control..

Study group will have two virtual visits (months 3 and 6) Control group will have all quarterly visits in person. A laptop will be used for virtual visits and will be set up with the help of the TTUHSC Information Technology Security Officer.

Study Timeline

• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Study Start: 2014-12
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-- Age 10-18 years

• Multiple daily injections regimen
• Duration of diabetes > 12 months
• HbA1c > 7%
• Lives outside of Lubbock
• Committed to visit schedule

Exclusion Criteria

• Foster care or residential facility
• Psychiatric illness
• Developmental delay
• Reading at < 4th grade level
• Pregnancy
• Known seizure disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Control Subjects will continue routine care which requires blood glucose testing at least 4 times a day. Parents will use customary ways to communicate (pager, email, fax or phone) with the Diabetes team, if they are concerned about glycemic control..
Telemedicine	Telemedicine	Telemedicine group will test blood glucose at least 4 times a day Each time the meter time-stamps the reading. All meter readings will upload to the cloud via "Myglucohealth" website, where they can be accessed by caregivers, including providers and parents. Parents will be notified by device about the blood glucose testing results. Provider will set device to alert patient or patient's family or send alerts if uploaded numbers are outside an identified range (\<70 mg/dL \> 300 mg/dL). As per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. Parents will be encouraged to contact study personnel if they are concerned about the diabetes control. Study personnel will access home blood glucose monitor data, and provide insulin dosing advice. Parents will be asked to upload blood glucose readings prior to each visit.

Primary Outcome Measures

Name	Time	Method
hemoglobin A1c	12 months	As an indicator of diabetes control

Secondary Outcome Measures

Name	Time	Method
Frequency of contact with diabetes care team	12 months	To see if tele-communication is used more than the conventional (phone, FAX)

Trial Locations

Locations (1)

TTUHSC Pediatric Clinic; 🇺🇸 Lubbock, Texas, United States