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Telemedicine for Adolescents With Insulin-dependent Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Control
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring type 1 diabetes, home glucose monitor, upload, cloud

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TTUHSC Pediatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine

Control

Arm Description

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.

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..

Outcomes

Primary Outcome Measures

hemoglobin A1c
As an indicator of diabetes control

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2014
Last Updated
December 6, 2019
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT02155855
Brief Title
Telemedicine for Adolescents With Insulin-dependent Diabetes
Official Title
Effectiveness of and Satisfaction With Remote Blood Glucose Monitoring and Telemedicine for Adolescents With Insulin-dependent Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, home glucose monitor, upload, cloud

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Routine care
Primary Outcome Measure Information:
Title
hemoglobin A1c
Description
As an indicator of diabetes control
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of contact with diabetes care team
Description
To see if tele-communication is used more than the conventional (phone, FAX)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daina Dreimane, MD
Organizational Affiliation
TTUHSC School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
TTUHSC Pediatric Clinic
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Telemedicine for Adolescents With Insulin-dependent Diabetes

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