Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03466398|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 1 Diabetes Mellitus||Behavioral: Vivify Health RPM Protocol||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes|
|Actual Study Start Date :||April 11, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Intervention Arm
Patients will use the Vivify Health RPM protocol as part of their diabetes management. They required to complete the Care Plan questions on a daily basis, and will upload blood glucose readings directly to the tablet twice a day. They will also have scheduled video conferences with study team physicians or advanced practice nurses on a weekly basis, to discuss ongoing diabetes management and educational objectives.
Behavioral: Vivify Health RPM Protocol
The Vivify RPM Protocol includes a wireless tablet and glucometer/Bluetooth device that can directly upload blood glucose readings to the tablet. Patients will daily Care Plan questionnaires on the tablet, as well as upload blood glucose readings twice a day. The tablets will also be used for weekly video conferences with study investigators.
No Intervention: Control Arm
Patients in this arm will manage their diabetes at home per normal standard of care, without any extra intervention from the study investigators.
- Hemoglobin A1c [ Time Frame: 3 months ]To determine whether 12 weeks of participation in a remote monitoring protocol utilizing remote glucose data uploads and video visits through a mobile device improves glycemic control as measured by Hemoglobin A1c in adolescents with poorly controlled Type 1 Diabetes.
- Diabetes Knowledge Test 2 (DKT2) score [ Time Frame: 6 months ]
To determine whether 12 weeks of participation in a remote monitoring protocol can improve diabetes knowledge as assessed by a questionnaire in adolescents with poorly controlled Type 1 Diabetes.
The DKT2 contains 2 sections, with 23 questions total. The first section is general knowledge, and has 14 items. The second section is an insulin-use subscale, with 9 items. Higher scores are better for both sections.
- Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) score [ Time Frame: 6 months ]
The first subscale (items 1-13) is Collaboration with Parents. Items 2 and 3 are reversed scored. The range of scores is 0 to 39. Higher scores indicate more collaboration.
The second subscale is Diabetes Care Activities (items 14-28). Items 16, 21, 22, 23, 25, 26 are reversed scored. The range is 0 to 45. Higher scores indicate better performance of diabetes tasks.
The third subscale is Diabetes Problem-Solving (items 29-35). Range of scores is 0 to 21. Higher scores indicate better problem-solving.
The fourth subscale is Diabetes Communication (items 36-45). The range of scores is 0 to 30. Higher scores indicate more communication.
The fifth subscale, Goals, is composed of items 1-7 of Part II of the instrument. The range of scores is 0 to 21. Higher scores indicate more goals.
Calculating a total score is not recommended.
- DKA Admission Rates [ Time Frame: 6 months ]To evaluate whether usage of the remote monitoring protocol affects hospital admission rates for adolescents with poorly controlled Type 1 Diabetes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466398
|Contact: Soumya Adhikari, MD||214-456-5959||SOUMYA.ADHIKARI@childrens.com|
|Contact: Huay-Lin Lo, MD||214-456-5959||Huay-Lin.Lo@utsouthwestern.edu|
|United States, Texas|
|Children's Medical Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Soumya Adhikari, MD email@example.com|
|Principal Investigator: Soumya Adhikari, MD|
|Sub-Investigator: Huay-Lin Lo, MD|
|Sub-Investigator: Sneha Patel, APN|
|Principal Investigator:||Soumya Adhikari, MD||UT Southwestern|