Telemedicine for Adolescents With Insulin-dependent Diabetes

NCT02155855 | Completed

• 1 other identifier: L14-037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, home glucose monitor, upload, cloud

Outcome Measures

Primary Outcomes (1)

• hemoglobin A1c

  As an indicator of diabetes control

  12 months

Secondary Outcomes (1)

• Frequency of contact with diabetes care team

  12 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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.

Telemedicine

Control OTHER

Routine care

Control

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \-- Age 10-18 years
• Multiple daily injections regimen
• Duration of diabetes \> 12 months
• HbA1c \> 7%
• Lives outside of Lubbock
• Committed to visit schedule

You may not qualify if:

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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

TTUHSC Pediatric Clinic

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Daina Dreimane, MD

  TTUHSC School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

US (1)