Telemedicine for Adolescents With Insulin-dependent Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155855
• Other study ID #: L14-037
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2019
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Telemedicine
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
Routine care

Locations

Country	Name	City	State
United States	TTUHSC Pediatric Clinic	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c	As an indicator of diabetes control	12 months
Secondary	Frequency of contact with diabetes care team	To see if tele-communication is used more than the conventional (phone, FAX)	12 months