Using mHealth to Modernize Diabetes Care
MDM
Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy
1 other identifier
observational
400
0 countries
N/A
Brief Summary
In this study the investigators are testing a device that may help us tell how well the participants' wound is healing. This device is called the MIMOSA, and it shines different "colours" of light on the participants' skin. It will not touch the participants' skin, or change how the participants' wound is healing. The MIMOSA is designed to be used alongside the camera that is built into the participants' cell phone, and the investigators will use a cell phone to take a picture of the participants' skin. This picture will tell us how much oxygen is getting to the participants' wound, which can tell us more about how the participants are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how the participants' wound is healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
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
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 4, 2018
April 1, 2018
1.6 years
March 8, 2018
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower rates of DFU recurrence in patients monitored using mHealth
Accurately recorded pictures and information will help clinicians to accurately access patient foot health and hopefully reduce the frequency of DFU's using this information.
0-12 months
Study Arms (4)
St. Michael's Hospital
St. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100
South Riverdale Community Health Centre
South Riverdale is a Community Health Centre focused on prevention. n=100
Westpark
Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100
Women's College Hospital
Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100
Interventions
The MIMOSA shines different "colours" of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing.
Eligibility Criteria
Adult diabetic subjects will be identified as candidates for our study if they present to the outpatient clinic, emergency department, inpatient or wound care team with or without a DFU. A subject is considered a patient with a DFU on one foot. If the patient has 2 wounds on the same foot, they are still considered one subject and both wounds are imaged. If the subject has a wound on the opposite foot they are considered a new subject.
You may qualify if:
- Diabetes: Type I or Type II.
- Outpatient or inpatient
- Diabetic Foot Ulcer
- Adhere to monitoring schedule
You may not qualify if:
- Presence of invasive infection requiring intravenous antibiotics
- Cognitively able to give consent \& participate in study
- Active malignancy
- End stage renal disease
- Patients who are participating in another clinical study for ulcer management
- Patients with a known history of poor compliance with medical treatment
- Patients who are unable to understand the aims of the study and not give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- South Riverdale Community Health Centrecollaborator
- West Park Healthcare Centrecollaborator
- Women's College Hospitalcollaborator
Related Publications (5)
Pelletier C, Dai S, Roberts KC, Bienek A, Onysko J, Pelletier L. Report summary. Diabetes in Canada: facts and figures from a public health perspective. Chronic Dis Inj Can. 2012 Dec;33(1):53-4.
PMID: 23294922BACKGROUNDSkrepnek GH, Mills JL Sr, Armstrong DG. A Diabetic Emergency One Million Feet Long: Disparities and Burdens of Illness among Diabetic Foot Ulcer Cases within Emergency Departments in the United States, 2006-2010. PLoS One. 2015 Aug 6;10(8):e0134914. doi: 10.1371/journal.pone.0134914. eCollection 2015.
PMID: 26248037BACKGROUNDSerrano V, Spencer-Bonilla G, Boehmer KR, Montori VM. Minimally Disruptive Medicine for Patients with Diabetes. Curr Diab Rep. 2017 Sep 23;17(11):104. doi: 10.1007/s11892-017-0935-7.
PMID: 28942581BACKGROUNDCross KM, Leonardi L, Payette JR, Gomez M, Levasseur MA, Schattka BJ, Sowa MG, Fish JS. Clinical utilization of near-infrared spectroscopy devices for burn depth assessment. Wound Repair Regen. 2007 May-Jun;15(3):332-40. doi: 10.1111/j.1524-475X.2007.00235.x.
PMID: 17537120BACKGROUNDVashist SK, Schneider EM, Luong JH. Commercial Smartphone-Based Devices and Smart Applications for Personalized Healthcare Monitoring and Management. Diagnostics (Basel). 2014 Aug 18;4(3):104-28. doi: 10.3390/diagnostics4030104.
PMID: 26852680BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2018
First Posted
May 4, 2018
Study Start
May 15, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 4, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share
All personal health information given will be anonymized when it is collected: a master linking log will link potentially identifiable characteristics to a specific study ID number listed in the app, to be held only by the Principal Investigator under lock or encryption and password protection. Study data seen by research assistants and data analysts will be strictly anonymized, encrypted, password protected, and stored in a locked research lab, separately from the master linking log.