Skip to main content
OpenTrials
Completed

NCT Number: NCT02155855

Telemedicine for Adolescents With Insulin-dependent Diabetes

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TTUHSC Pediatric Clinic

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Other

Study group will test blood glucose at least 4 times a day Each time the meter timestamps 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.

Control

Other

Routine care

Primary outcomes

  1. hemoglobin A1c

    Time frame: 12 months

    As an indicator of diabetes control

Secondary outcomes

  1. Frequency of contact with diabetes care team

    Time frame: 12 months

    To see if tele-communication is used more than the conventional (phone, FAX)

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Effectiveness of and Satisfaction With Remote Blood Glucose Monitoring and Telemedicine for Adolescents With Insulin-dependent Diabetes

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2014
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.