Plain English Summary
Background and study aims
This Project Dulce study will examine the impact of different strategies on glycemic control, diabetes self-management, quality of life and healthy life style for patients with type 2 diabetes (when the body does not produce enough insulin or the body does not react to insulin) in underserved communities in Mexico.
Who can participate?
Adults with type 2 diabetes, poor metabolic control and no current use of insulin.
What does the study involve?
Participants will be randomly allocated to one of three groups:
- Project Dulce only (PD): Clinical management by medical and nurse-certified diabetes educators and self-management education provided by community workers.
- Project Dulce + Technology Enhanced model (PD-TE): same as above plus use of Glucose meters with USB connections, cell phones with 3G technology for real-time data relay, alerts by text messages, wireless technology for improved communication between patients, doctors and community workers.
- Standard care (Control): monthly visit to doctor, access to laboratories and medications and educational classes.
What are the possible benefits and risks of participating?
Participants are able to receive additional educational and technological resources in order to improve the management of their condition, metabolic outcomes, healthy life style and quality of life. If participants are in the Control group, they are to receive the outreach education after the completion of the study. Apart from some discomfort due to glucose testing, there are no significant risks for the partcipants.
Where is the study run from?
The study is conducted in the largest Family Medicine Clinic of Mexico in Tijuana, Mexico.
When is the study starting and how long is it expected to run for?
The study started in November 2011 and will finish in March 2014.
Who is funding the study?
Private and public sector. The main financial sponsors are Qualcomm Inc. and IUSACELL. Other in-kind contributors are the Instituto Mexicano del Seguro Social (IMSS), the International Community Foundation (ICF), Universidad Autónoma de Baja California (UABC), Scrips Whittier Diabetes Institute (SWDI), Fronteras Unidas Pro Salud, (Pro Salud) and the Fundación Internacional de la Comunidad (FIC).
Who is the main contact?
Dra. María Cecilia Anzaldo Campos
maria.anzaldo@imss.gob.mx
Trial website
Contact information
Type
Scientific
Primary contact
Dr Maria Cecilia Anzaldo-Campos
ORCID ID
Contact details
Boulevard Diaz Ordaz S/N Km 11.5
Fraccionamiento La Mesa
Tijuana
22650
Mexico
+52 664 6-29-63-85
maria.anzaldo@imss.gob.mx
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CNIC-R-2011-785-019
Study information
Scientific title
Dulce Wireless Tijuana: A randomized controlled trial studying the impact of the project Dulce TM and mobile technology on metabolic outcomes, quality of life and behaviors
Acronym
DWT
Study hypothesis
The benefit observed in metabolic control, lifestyle, quality of life, self-efficacy in the management and knowledge of the disease is higher in the intervention groups compared with the control group.
Ethics approval
National Research Commission and its Bioethical Committee of the Instituto Mexicano del Seguro Social (IMSS); August 2011; ref: CNIC-R-2011-785-019
Study design
Clinical randomized controlled trial single blind single-centered with 3 parallell groups and a 10th month follow-up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes Type 2
Intervention
The DWT study randomly assigned patients to the following three arms:
1. Project Dulce TM intervention only (PD)
2. Project Dulce + Technology Enhanced intervention(PD-TE)
3. Standard of care (Control)
1. The clinical education arm Project Dulce (PD) is based on the Project Dulce™ chronic care multidisciplinary model with peer-led diabetes education and consists of two components:
1.1. Clinical management by medical and nurse-certified diabetes educators trained in the multidisciplinary chronic care model and use of clinical algorithms.
1.2. Self-management education provided by community workers. The outreach workers follow the peer educational curriculum Diabetes Among FriendsTM. Patients receive eight diabetes self-management sessions and one orientation by the outreach workers during the first two months of the study. After these two months, patients are invited to participate in eight monthly support meetings.
2. The Project Dulce-Technology Enhanced (PD-TE) arm included the same Project Dulce Model as in PD plus the following technology:
2,.1. Glucose meters with USB connections: We provided glucose meters to patients. They measure their glucose levels twice a day during the first month and biweekly the second month. Measures were uploaded via a USB connection at the end of the week.
2.2 Cell phones with 3G technology that allow: An interactive motivational survey via 3G mobile cell phones able to relay data in real-time. This survey is sent once a day during the first month and twice a week the second month; culturally appropriate designed videos and educational materials uploaded to patients cell phones. Patients were encouraged to watch these videos and materials as they pleased in order to clarify the topics covered during classes.
2.3. Compatible electronic diabetes management registry able to send alerts and notifications via SMS . Patients received alerts via text messages when they reported glucose readings below or above the normal range. They also received notifications when they missed an appointment at the clinic, at the laboratory or a class.
2.4. Wireless technology will allow clinical, administrative staff and community outreach workers to share patient information, avoid duplication and keep patients from falling through the cracks of an otherwise fragmented system of care. The technology-enhanced arm of the study works by consolidating and centralizing patient information and by extending diabetes education to communities via 3G services such as interactive surveys, relevant video content and community classes. Patients, promotores (community health workers), nurses, and doctors access the system via mobile devices such as cell phones, smartphones, netbooks and laptops. Technology facilitates communication among the different levels of care, including, primary care, community outreach and the patients home or work.
3. The Control Group (CG) received the standard of care provided by IMSS guidelines. The standard of care includes access to a monthly visit with a physician for an average of 15 minutes. It also includes access to laboratories and medications. Educational classes are available for patients that are willing and able to participate. Also, patients were able to participate in a model of group medical visits once a month under the program DiabetIMSS. Approximately half of the patients joined the medical group modality and the other half remained with the traditional one-on-one care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Hb A1C measured using metabolic tests at baseline, fourth and tenth month
Secondary outcome measures
1. Quality of life (QoL) is evaluated using the Diabetes 39 instrument . This instrument has been validated in Spanish and in Mexico by Juan Manuel Lopez-Carmona and Raymundo Rodriguez-Moctezuma.
2. Lifestyles (LS) are evaluated using the IMEVID instrument (Instrument to measure lifestyle of type 2 diabetes mellitus patients). This instrument has been validated in Spanish and in Mexico by Juan Manuel Lopez-Carmona et.al.
3. Self efficacy is evaluated using the instrument Spanish Diabetes Self-Eficacy. This instrument was prepared by Stanford Patient Education Research Center and was adapted to Spanish.
4. Depression measured by the PHQ9 instrument at baseline and the tenth month. This instrument is developed by Spitzer et.al. and has been validated to Spanish.
5. Diabetes knowledge evaluated using the Diabetes Knowledge Questionnaire 24. This instrument was develop and validated to Spanish by Alexandra A. Gracia, et.al. (The Starr County Diabetes Education Study)
6. Total cholesterol, HDL, LDL and triglycerides measured at baseline, fourth and tenth month
Overall trial start date
11/01/2011
Overall trial end date
04/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults 18-75 years old
2. Diabetes Mellitus type 2
3. Glycated haemoglobin (HbA1c) ≥8%
4. No current insulin use
5. Member or holder of IMSS clinic 27 insurance
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patients without insurance to IMSS UMF No. 27
2. Pregnant women
3. Patients without physical or mental capacity to attend clinic visits and self-care classes for reasons beyond diabetes
Recruitment start date
11/01/2011
Recruitment end date
04/01/2014
Locations
Countries of recruitment
Mexico
Trial participating centre
Boulevard Diaz Ordaz S/N Km 11.5
Tijuana
22650
Mexico
Sponsor information
Organisation
Mexican Social Security Institute (Instituto Mexicano del Seguro Social) (Mexico)
Sponsor details
c/o Maria Cecilia Anzaldo-Campos
UMF No. 27/
Boulevard Diaz Ordaz S/N Km 11.5
Fraccionamiento La Mesa
Tijuana
22650
Mexico
+52 664 6-29-63-85
maria.anzaldo@imss.gob.mx
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Qualcomm Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Iusacell (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26914371 (added 23/01/2019)