NCT03466398

Brief 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 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

February 20, 2018

Last Update Submit

May 12, 2020

Conditions

Diabetes MellitusType 1 Diabetes Mellitus

Keywords

Remote Patient MonitoringAdolescents

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Diabetes Knowledge Test 2 (DKT2) score

    6 months

  • Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) score

    6 months

  • DKA Admission Rates

    6 months

Study Arms (2)

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.

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.

Interventions

Vivify Health RPM ProtocolBEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (16)

  • 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.

    PMID: 23733895BACKGROUND

  • Centers 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

  • 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.

    PMID: 24356592BACKGROUND

  • Wood 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.

    PMID: 23340893BACKGROUND

  • Randall 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.

    PMID: 21775761BACKGROUND

  • Ozcan 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.

    PMID: 25128266BACKGROUND

  • Ziegler 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.

    PMID: 20337978BACKGROUND

  • Campbell 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.

    PMID: 23957219BACKGROUND

  • Pimouguet 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.

    PMID: 21149524BACKGROUND

  • Shea 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.

    PMID: 19390093BACKGROUND

  • Nundy 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.

    PMID: 25278512BACKGROUND

  • Franklin 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.

    PMID: 17116184BACKGROUND

  • Malloy 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.

    PMID: 23949666BACKGROUND

  • Jacob 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.

    PMID: 23279278BACKGROUND

  • Fitzgerald 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.

    PMID: 26769757RESULT

  • Schilling LS, Dixon JK, Knafl KA, Lynn MR, Murphy K, Dumser S, Grey M. A new self-report measure of self-management of type 1 diabetes for adolescents. Nurs Res. 2009 Jul-Aug;58(4):228-36. doi: 10.1097/NNR.0b013e3181ac142a.

    PMID: 19561555RESULT

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Soumya Adhikari, MD

    UT Southwestern

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 15, 2018

Study Start

April 11, 2018

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)