This application is in response to the GACD solicitation of applications (NOT-TW-14-003) in response to the existing trans-NIH Initiative on Dissemination and Implementation Science (PAR-13-054). There are an estimated 285 million people worldwide living with diabetes, 70% of whom are in low and middle- income countries (LMIC). Underdiagnoses of diabetes is particularly significant in LMIC, where less than 50% of diabetics are diagnosed. When diagnosis does not occur before the onset of clinical manifestations of the disease, complications and morbidity rise exponentially. Therefore, one of the major challenges in diabetes control in these limited resource settings is the need for a resource-appropriate, rapid screening method to identify diabetics and treat them early enough to delay the onset of complications. Diabetic Foot Neuropathy (DFN) is one of the most important complications and is one of the most significant prognostics for foot amputation. Early diagnosis and intervention can prevent foot ulcers and amputation, minimizing the social and economic costs of diabetes. The gold standard for diagnosis of DFN is a nerve conduction study, but unfortunately this is very costly and time consuming. Therefore, this is not an appropriate technology for LMIC settings, and a simple and inexpensive monitoring method is needed. Thermometry measures local skin warmth and is one of the more promising emerging modalities for the evaluation of DFU. However, patient compliance with at-home monitoring is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, we propose to determine the utility of SMS messaging to remind the patients to perform the thermometry, and to assess the impact on outcome. We will enroll diabetic subjects with neuropathy at risk for ulceration into a clinical study with two arms: both arms will receive education about DFU at the beginning of the study, and will be provided with a foot thermometer and instructions on its use. They will be asked to record multiple foot temperature measurements on a daily basis. However, one arm will also receive text messages reminding them to use the thermometer, while the other arm will not. With this study, we will perform the following specific aims:
Specific Aim 1. Compare the incidence of DFU during the study between the two arms. We hypothesize that subjects who receive SMS will have a lower incidence of DFU than the subjects who do not receive SMS.
Specific Aim 2. Compare compliance with foot thermometer use between the two arms. We hypothesize that subjects who receive SMS will be more compliant with temperature measurement.

Public Health Relevance

Diabetic Foot Neuropathy (DFN) is one of the most important complications of diabetes, and can have a huge impact on patients, families, and society. Early diagnosis and intervention can prevent foot ulcers and amputation, minimizing the social and economic costs of diabetes. We propose to evaluate novel methods to allow diabetic patients to self-identify the early warning signs of DFN.

Agency
National Institute of Health (NIH)
Institute
Fogarty International Center (FIC)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21TW009982-01
Application #
8807993
Study Section
Dissemination and Implementation Research in Health Study Section (DIRH)
Program Officer
Said, Maria
Project Start
2014-09-25
Project End
2016-09-25
Budget Start
2014-09-25
Budget End
2015-09-25
Support Year
1
Fiscal Year
2014
Total Cost
$190,715
Indirect Cost
$14,127
Name
Universidad Peruana Cayetano Heredia
Department
Type
DUNS #
934798430
City
Lima
State
Country
Peru
Zip Code
LIMA -31