Clinical trial NCT02155855: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, home glucose monitor, upload, cloud
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of contact with diabetes care team
timeFrame: 12 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTUHSC Pediatric Clinic
state: Texas
Study officials:
affiliation: TTUHSC School of Medicine
name: Daina Dreimane, MD
role: PRINCIPAL_INVESTIGATOR
References: