Telemedicine for Adolescents With Insulin-dependent Diabetes

Effectiveness of and Satisfaction With Remote Blood Glucose Monitoring and 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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Telemedicine; Other: 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • TTUHSC Pediatric Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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..	Other: Control; Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin A1c	As an indicator of diabetes control	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Daina Dreimane, MD, TTUHSC School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: type 1 diabetes, home glucose monitor, upload, cloud
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: L14-037