Diabetes MellitusNCT03466398
Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
A study testing Vivify Health RPM Protocol in people with Diabetes Mellitus and Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes Mellitus
- What is being tested?
- Vivify Health RPM Protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-18 years old
- Diagnosed with Type 1 Diabetes Mellitus >1 year ago with at least one positive diabetes autoantibody
- Patient on multiple daily injections of insulin, with no change to insulin type within the past 3 months
- ≥2 separate HbA1c values (at least 60 days apart) ≥10.0% in the past year, with the most recent HbA1c value ≥10.0%
- English-Speaking (patient and at least 1 parent)
- Patient or parents must own a smart phone or other device compatible with Glooko
Who cannot join
- Patients on Continuous Subcutaneous Insulin Infusion
- Diagnosed with Type 2 Diabetes or taking metformin
- Other chronic medical condition that would be likely to affect blood glucose. Exceptions include:
- Hypothyroidism on treatment with normal thyroid function tests
- Asthma with no oral steroids within past 3 months
- Unstable social situation that could compromise diabetes management or study follow-up in the judgment of the investigators
Trial locations and contacts
1 site in 1 country.
About this study
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate treatment groups. Group A will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes management per standard of care, including quarterly office visits. After a period of 12 weeks, Group B will switch to the RPM protocol, while Group A will return to standard of care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.
Read the detailed description
RPM Software The Remote Patient Monitoring application that will be used for this study was created by Vivify Health. Vivify Health was founded in 2009, and their Remote Care Management platform utilizes consumer electronics and wireless health devices that patients can use easily from home. Using this platform, providers can create customized care plans for patients, as well as provide education through multimedia and face-to-face interaction through video conferences.
The Glooko mobile application allows patients to download diabetes data, including blood sugar readings, directly from their meter to compatible iOS and Android devices. The data can then be uploaded by the patient and viewed by providers.
Subjects Prospective study participants will be screened for by review of HbA1c values of patients with upcoming Endocrine clinic appointments, or during diabetes-related hospital admissions. Qualifying patients will be invited to participate in the study and written consent will be obtained from their parents (and assent from patients 10 years of age and older) prior to their randomization. Patients agreeing to participate in the study will be randomly assigned using sealed, blinded envelopes to Group A or Group B. Each group will have 25 patients.
Pre-Study Measurements Both groups will have HbA1c measured at the pre-study clinic visit or hospital admission as part of standard of care. After consenting to participation, each subject will schedule a brief telephone check-in with an investigator within 1 week of the initial encounter. Successful adherence to this telephone appointment will be used as a barometer of ability to follow through on scheduled remote communications, and will be required for randomization. After completing the telephone check-in, each patient will return within 2 weeks of the initial encounter. At this visit, randomization will occur, and they will complete 2 questionnaires at the beginning of the study: one knowledge assessment (the Diabetes Knowledge Test 2 (DKT2)) [15] and one assessment of self-efficacy (the Self-Management of Type 1 Diabetes in Adolescence (SMOD-A)) [16].
Intervention Groups Group A will be taught the remote monitoring expectations and will receive training on how to use the Vivify RPM software at the same visit that randomization occurs. Subjects in this group will be enrolled in the RPM protocol for the first 12 weeks of their participation in the study. While on the RPM protocol, subjects will be required to complete the Care Plan questions on a daily basis. They will also have scheduled video conferences with study team physicians or advanced practice nurses on a weekly basis, and will be expected to upload their blood glucose readings to Glooko each week for review. A web-based provider dashboard will allow the study team to monitor patients' usage of the software on a daily basis. Video visits are anticipated to last 15-20 minutes. During this time the study team will review the data collected during the previous week, discuss ongoing diabetes management and any barriers to care, and review selected diabetes self-management educational topics with study participants. The Care Plan questions, Weekly Conference questions, and Educational Objectives intended to be covered during the video visits are appended to the end of this document. Patients in Group B will complete all pre-study measurements at randomization, but remain on a quarterly visit schedule as per standard of care for the first 12 weeks of their participation in the study.
After the first 12 weeks, patients in Group A will return to quarterly office visits with their endocrinology team as per standard of care while patients in Group B enter into the RPM protocol. Both groups will have a clinic visit with HbA1c checked, and will complete the DKT2 and SMOD-A questionnaires for the 2nd time.
The study will conclude with the 6 month visit for both groups. Both groups will have a HbA1c checked, and will complete the post-study DKT2 and SMOD-A questionnaires for the 3rd and final time.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes Mellitus
- Being tested
- Vivify Health RPM Protocol
- Keywords
- Remote Patient Monitoring, Adolescents
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivify Health RPM ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Vivify Health RPM Protocol |
| Control Arm | No intervention | Patients in this arm will manage their diabetes at home per normal standard of care, without any extra intervention from the study investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
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.
Measured: 3 months
Secondary outcomes (3)
Diabetes Knowledge Test 2 (DKT2) score
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.
Measured: 6 months
Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) score
Scoring:
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.
Measured: 6 months
DKA Admission Rates
To evaluate whether usage of the remote monitoring protocol affects hospital admission rates for adolescents with poorly controlled Type 1 Diabetes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start11 Apr 2018
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: Technical limitations encountered with the remote monitoring platform
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vivify Health
- Responsible party
- Sponsor
- Investigators
- Soumya Adhikari, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466398
- Sponsor's protocol ID
- STU 122016-056
- Status last verified
- May 2020
- First submitted
- 20 Feb 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egro FM. Why is type 1 diabetes increasing? J Mol Endocrinol. 2013 Jul 12;51(1):R1-13. doi: 10.1530/JME-13-0067. Print 2013.
PubMed 23733895Centers for Disease Control and Prevention., National Diabetes Statistics Report: Estimates of Diabetes and its Burden in the United States, 2014. US Department of Health and Human Services; 2014: Atlanta, GA.
Nathan DM; DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. doi: 10.2337/dc13-2112.
PubMed 24356592Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
PubMed 23340893Randall L, Begovic J, Hudson M, Smiley D, Peng L, Pitre N, Umpierrez D, Umpierrez G. Recurrent diabetic ketoacidosis in inner-city minority patients: behavioral, socioeconomic, and psychosocial factors. Diabetes Care. 2011 Sep;34(9):1891-6. doi: 10.2337/dc11-0701. Epub 2011 Jul 20.
PubMed 21775761Ozcan S, Amiel SA, Rogers H, Choudhary P, Cox A, de Zoysa N, Hopkins D, Forbes A. Poorer glycaemic control in type 1 diabetes is associated with reduced self-management and poorer perceived health: a cross-sectional study. Diabetes Res Clin Pract. 2014 Oct;106(1):35-41. doi: 10.1016/j.diabres.2014.07.023. Epub 2014 Jul 26.
PubMed 25128266Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R; DPV-Wiss-Initiative. Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2011 Feb;12(1):11-7. doi: 10.1111/j.1399-5448.2010.00650.x.
PubMed 20337978Campbell MS, Schatz DA, Chen V, Wong JC, Steck A, Tamborlane WV, Smith J, Beck RW, Cengiz E, Laffel LM, Miller KM, Haller MJ; T1D Exchange Clinic Network. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes. 2014 Mar;15(2):110-7. doi: 10.1111/pedi.12067. Epub 2013 Aug 19.
PubMed 23957219Pimouguet C, Le Goff M, Thiebaut R, Dartigues JF, Helmer C. Effectiveness of disease-management programs for improving diabetes care: a meta-analysis. CMAJ. 2011 Feb 8;183(2):E115-27. doi: 10.1503/cmaj.091786. Epub 2010 Dec 13.
PubMed 21149524Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.
PubMed 19390093Nundy S, Mishra A, Hogan P, Lee SM, Solomon MC, Peek ME. How do mobile phone diabetes programs drive behavior change? Evidence from a mixed methods observational cohort study. Diabetes Educ. 2014 Nov-Dec;40(6):806-19. doi: 10.1177/0145721714551992. Epub 2014 Oct 2.
PubMed 25278512Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Diabet Med. 2006 Dec;23(12):1332-8. doi: 10.1111/j.1464-5491.2006.01989.x.
PubMed 17116184Malloy LE, Gingerich J, Olson MD, Atkins DL. Remote monitoring of cardiovascular implantable devices in the pediatric population improves detection of adverse events. Pediatr Cardiol. 2014 Feb;35(2):301-6. doi: 10.1007/s00246-013-0774-5. Epub 2013 Aug 15.
PubMed 23949666Jacob E, Duran J, Stinson J, Lewis MA, Zeltzer L. Remote monitoring of pain and symptoms using wireless technology in children and adolescents with sickle cell disease. J Am Assoc Nurse Pract. 2013 Jan;25(1):42-54. doi: 10.1111/j.1745-7599.2012.00754.x. Epub 2012 Jul 12.
PubMed 23279278Fitzgerald JT, Funnell MM, Anderson RM, Nwankwo R, Stansfield RB, Piatt GA. Validation of the Revised Brief Diabetes Knowledge Test (DKT2). Diabetes Educ. 2016 Apr;42(2):178-87. doi: 10.1177/0145721715624968. Epub 2016 Jan 14.
PubMed 26769757
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03466398
- Acronym / sponsor ID
- STU 122016-056
- Conditions
- Diabetes Mellitus, Type 1 Diabetes Mellitus
- Keywords
- Remote Patient Monitoring, Adolescents
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical limitations encountered with the remote monitoring platform
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Vivify Health
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate treatment groups. Group A will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes management per standard of care, including quarterly office visits. After a period of 12 weeks, Group B will switch to the RPM protocol, while Group A will return to standard of care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.
Detailed description
RPM Software The Remote Patient Monitoring application that will be used for this study was created by Vivify Health. Vivify Health was founded in 2009, and their Remote Care Management platform utilizes consumer electronics and wireless health devices that patients can use easily from home. Using this platform, providers can create customized care plans for patients, as well as provide education through multimedia and face-to-face interaction through video conferences.
The Glooko mobile application allows patients to download diabetes data, including blood sugar readings, directly from their meter to compatible iOS and Android devices. The data can then be uploaded by the patient and viewed by providers.
Subjects Prospective study participants will be screened for by review of HbA1c values of patients with upcoming Endocrine clinic appointments, or during diabetes-related hospital admissions. Qualifying patients will be invited to participate in the study and written consent will be obtained from their parents (and assent from patients 10 years of age and older) prior to their randomization. Patients agreeing to participate in the study will be randomly assigned using sealed, blinded envelopes to Group A or Group B. Each group will have 25 patients.
Pre-Study Measurements Both groups will have HbA1c measured at the pre-study clinic visit or hospital admission as part of standard of care. After consenting to participation, each subject will schedule a brief telephone check-in with an investigator within 1 week of the initial encounter. Successful adherence to this telephone appointment will be used as a barometer of ability to follow through on scheduled remote communications, and will be required for randomization. After completing the telephone check-in, each patient will return within 2 weeks of the initial encounter. At this visit, randomization will occur, and they will complete 2 questionnaires at the beginning of the study: one knowledge assessment (the Diabetes Knowledge Test 2 (DKT2)) [15] and one assessment of self-efficacy (the Self-Management of Type 1 Diabetes in Adolescence (SMOD-A)) [16].
Intervention Groups Group A will be taught the remote monitoring expectations and will receive training on how to use the Vivify RPM software at the same visit that randomization occurs. Subjects in this group will be enrolled in the RPM protocol for the first 12 weeks of their participation in the study. While on the RPM protocol, subjects will be required to complete the Care Plan questions on a daily basis. They will also have scheduled video conferences with study team physicians or advanced practice nurses on a weekly basis, and will be expected to upload their blood glucose readings to Glooko each week for review. A web-based provider dashboard will allow the study team to monitor patients' usage of the software on a daily basis. Video visits are anticipated to last 15-20 minutes. During this time the study team will review the data collected during the previous week, discuss ongoing diabetes management and any barriers to care, and review selected diabetes self-management educational topics with study participants. The Care Plan questions, Weekly Conference questions, and Educational Objectives intended to be covered during the video visits are appended to the end of this document. Patients in Group B will complete all pre-study measurements at randomization, but remain on a quarterly visit schedule as per standard of care for the first 12 weeks of their participation in the study.
After the first 12 weeks, patients in Group A will return to quarterly office visits with their endocrinology team as per standard of care while patients in Group B enter into the RPM protocol. Both groups will have a clinic visit with HbA1c checked, and will complete the DKT2 and SMOD-A questionnaires for the 2nd time.
The study will conclude with the 6 month visit for both groups. Both groups will have a HbA1c checked, and will complete the post-study DKT2 and SMOD-A questionnaires for the 3rd and final time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Vivify Health RPM ProtocolPatients 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. |
| Control Arm | No intervention | –Patients in this arm will manage their diabetes at home per normal standard of care, without any extra intervention from the study investigators. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 13-18 years old
- Diagnosed with Type 1 Diabetes Mellitus >1 year ago with at least one positive diabetes autoantibody
- Patient on multiple daily injections of insulin, with no change to insulin type within the past 3 months
- ≥2 separate HbA1c values (at least 60 days apart) ≥10.0% in the past year, with the most recent HbA1c value ≥10.0%
- English-Speaking (patient and at least 1 parent)
Key exclusion criteria (6 listed)
- Patients on Continuous Subcutaneous Insulin Infusion
- Diagnosed with Type 2 Diabetes or taking metformin
- Other chronic medical condition that would be likely to affect blood glucose. Exceptions include:
- Unstable social situation that could compromise diabetes management or study follow-up in the judgment of the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivify Health RPM ProtocolThe 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. | Behavioural | Intervention Arm |
Primary outcome
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.
3 secondary outcomes
Diabetes Knowledge Test 2 (DKT2) score
Time frame: 6 months
Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) score
Time frame: 6 months
DKA Admission Rates
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 23733895Egro FM. Why is type 1 diabetes increasing? J Mol Endocrinol. 2013 Jul 12;51(1):R1-13. doi: 10.1530/JME-13-0067. Print 2013.
- BackgroundCenters for Disease Control and Prevention., National Diabetes Statistics Report: Estimates of Diabetes and its Burden in the United States, 2014. US Department of Health and Human Services; 2014: Atlanta, GA.
- Background: PubMed 24356592Nathan DM; DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. doi: 10.2337/dc13-2112.
- Background: PubMed 23340893Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
- Background: PubMed 21775761Randall L, Begovic J, Hudson M, Smiley D, Peng L, Pitre N, Umpierrez D, Umpierrez G. Recurrent diabetic ketoacidosis in inner-city minority patients: behavioral, socioeconomic, and psychosocial factors. Diabetes Care. 2011 Sep;34(9):1891-6. doi: 10.2337/dc11-0701. Epub 2011 Jul 20.
- Background: PubMed 25128266Ozcan S, Amiel SA, Rogers H, Choudhary P, Cox A, de Zoysa N, Hopkins D, Forbes A. Poorer glycaemic control in type 1 diabetes is associated with reduced self-management and poorer perceived health: a cross-sectional study. Diabetes Res Clin Pract. 2014 Oct;106(1):35-41. doi: 10.1016/j.diabres.2014.07.023. Epub 2014 Jul 26.
- Background: PubMed 20337978Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R; DPV-Wiss-Initiative. Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2011 Feb;12(1):11-7. doi: 10.1111/j.1399-5448.2010.00650.x.
- Background: PubMed 23957219Campbell MS, Schatz DA, Chen V, Wong JC, Steck A, Tamborlane WV, Smith J, Beck RW, Cengiz E, Laffel LM, Miller KM, Haller MJ; T1D Exchange Clinic Network. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes. 2014 Mar;15(2):110-7. doi: 10.1111/pedi.12067. Epub 2013 Aug 19.
- Background: PubMed 21149524Pimouguet C, Le Goff M, Thiebaut R, Dartigues JF, Helmer C. Effectiveness of disease-management programs for improving diabetes care: a meta-analysis. CMAJ. 2011 Feb 8;183(2):E115-27. doi: 10.1503/cmaj.091786. Epub 2010 Dec 13.
- Background: PubMed 19390093Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.
- Background: PubMed 25278512Nundy S, Mishra A, Hogan P, Lee SM, Solomon MC, Peek ME. How do mobile phone diabetes programs drive behavior change? Evidence from a mixed methods observational cohort study. Diabetes Educ. 2014 Nov-Dec;40(6):806-19. doi: 10.1177/0145721714551992. Epub 2014 Oct 2.
- Background: PubMed 17116184Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Diabet Med. 2006 Dec;23(12):1332-8. doi: 10.1111/j.1464-5491.2006.01989.x.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soumya Adhikari, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivify Health RPM Protocol in people with Diabetes Mellitus and Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466398, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.