Diabetes Mellitus, Type 2SMS4T2DNCT04236206
Short Message Service for Type 2 Diabetes
A study testing Mobile Phone Short Message Service in people with Diabetes Mellitus, Type 2, run by Alexandria University at 1 site in Egypt.
Trial summary
Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mobile Phone Short Message Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 10 Apr 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years old and more.
- Diagnosed with T2D up to 15 years according to the American Diabetes Association (ADA) standards (ADA, 2018).
- With poorly controlled diabetes, (pre-intervention HbA1c values of 7% up to 10%).
- Registered in the selected primary health care (PHC) centers and living in Alexandria.
- Currently on oral medication therapy (if purchased from the center pharmacy) and able to afford the cost for 6 months treatment (if purchased from an external pharmacy).
- Has a personal mobile phone.
- Know how to retrieve/read SMS on the mobile phone (Arabic alphabets).
- Available for the study duration.
Who cannot join
- Patients with clinical conditions that might interfere with the study such as pregnancy, mental illness, poor eyesight, hearing or vocalization, visual, renal or liver impairment, other serious illness or co-morbidities requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mobile Phone Short Message Service on Glycemic Control and Adherence to Treatment for Type 2 Diabetes
Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. A third type-Gestational diabetes mellitus (GDM)-is diagnosed in the second or third trimester of pregnancy and was not clearly overt diabetes prior to gestation (American Diabetes Association. Lifestyle management can enhance diabetes care and it includes diabetes self-management education and support (DSMES), medical nutrition therapy, physical activity, smoking cessation counselling, and psychosocial care. However, health systems cannot control all the factors that influence a person's overall health, as physicians are unable to check regularly what their patients eat or whether they properly adhere to their medications. Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role. Patients and care providers should work together to optimize lifestyle aspects through the entire care process. Telemedicine "healing at a distance" signifies the use of information and communication technology to improve patient outcomes by increasing access to care and medical information. Using mobile and wireless technologies to achieve health objectives (mHealth) can universally transform health services' delivery. Mobile phones can easily reach population since they have exceeded other communication technologies in Low and middle-Income countries (LMICs). The results of the present study will help the policy-makers in the MOHP to understand the importance of creating healthcare systems that meet the needs of patients and providers and develop DSMES strategy with the help of pharmacist educator and using innovative mobile phone technology.
Read the detailed description
The global prevalence of diabetes among adults aged over 18 years old has increased from 4.7% in 1980 to 8.5% in 2014 (Mathers \& Loncar, 2006; WHO, 2018b). The World Health Organization (WHO) estimates that diabetes was the seventh leading cause of death in 2016 (WHO, 2016; WHO, 2018a). Current national statistics show that around 17% of all Egyptian adults have diabetes, and over 60% of diabetics receive no treatment (Eastern Mediterranean Regional Office (EMRO), 2016). According to the WHO, there will be 6,726,000 cases of diabetes in Egypt by 2030 (WHO, 2000).
Almost 45% of patients with T2D cannot achieve adequate glycemic control (HbA1c <7%). Poor medication adherence in T2D is a common public health problem and is associated with poor glycemic control, increased morbidity and mortality, and increased costs of outpatient care, emergency room visits, hospitalization, and managing complications of diabetes (Polonsky \& Henry, 2016).
Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role (Shane-McWhorter et al., 2009). Patients and care providers should work together to optimize lifestyle aspects through the entire care process (Abaza \& Marschollek, 2017).
In Egypt, the Ministry of Health and Population (MOHP) is partially implementing diabetes education, mostly in outpatient clinics via educational meetings or counselling with physicians/ nurses. Patients often report difficulty sticking to healthy lifestyles. They are also liable to forget or ignore their physician's advice after leaving the clinic. Therefore, they need an educational method that can easily reach them to make knowledgeable patients and save the physician's critical time (Abaza \& Marschollek, 2017).
According to the Ministry of Communications and Information Technology (MCIT) in Egypt, up to October 2019, there were 95.25 million mobile subscriptions as opposed to 8.72 million fixed-line subscriptions (Ministry of Communication and Information Technology [MCIT], 2019). Moreover, there were 38.67 million mobile internet users versus 7.17 million Asymmetric Digital Subscriber Line subscriptions in the same month; the mobile internet users could reflect the proportion of smartphone owners in the country (MCIT, 2019). In contrary to mobile internet or smartphone applications, short message service (SMS) can provide a simple way of communication reaching a larger population since almost all types of mobile phones support them (Abaza \& Marschollek, 2017).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mobile Phone Short Message Service
- Keywords
- Diabetes, Medication adherence, Telemedicine, mhealth, SMS
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone Short Message ServiceBehavioural
SMS content will be adopted from the validated Arabic national and international diabetes educational materials (Centers for Disease Control (CDC), 2018; Diabetes Australia, 2004; Diabetes Queensland, 2012; Utah Diabetes Control Program, 2005).
- The mobile phone SMSs will be pre-tested for clarity on a sample of 10 patients similar to the study population and their comments on the SMSs wording will be used to modify them to ensure acceptance.
- The SMS will be sent to participants using the internet, open-source software for bulk messages and a local telephone network provider.
- Patients will be encouraged to send messages/call the researcher for any queries encountered.
| Study group | Role | What they receive |
|---|---|---|
| SMS Recipients | Experimental | • Mobile phone SMSs will be sent to the intervention group with the aim of improving medication adherence and knowledge about diabetes, its complications, diet and physical activity. Receives: Behavioral: Mobile Phone Short Message Service |
| Non-SMS Recipients | No intervention | Control group with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
To assess the effect of the intervention on patients with type 2 diabetes in terms of glycemic control (HbA1c level).
Measured: Change from Baseline HbA1c level at 6 months.
Secondary outcomes (1)
Medication Adherence
To assess the effect of the intervention on patients with type 2 diabetes in terms of adherence to the prescribed hypoglycemic medications using the short form of adherence to refills and medications scale (ARMS-SF).
Measured: Change from Baseline Medication Adherence at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Oct 2020
- Primary completion30 Mar 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental; non-randomized, pre-test, post-test control group design.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- High Institute of Public Health, Egypt
- Responsible party
- Principal investigator, Rehab A. Rayan, Alexandria University
- Investigators
- Rehab A Rayan, PharmD, Principal investigator, High Institute of Public Health, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236206
- Sponsor's protocol ID
- RR-SMS4T2D-2020
- Acronym
- SMS4T2D
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Phone Short Message Service on Glycemic Control and Adherence to Treatment for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04236206
- Acronym / sponsor ID
- SMS4T2D / RR-SMS4T2D-2020
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Medication adherence, Telemedicine, mhealth, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- High Institute of Public Health, Egypt
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 22 Jan 2020 (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.
Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. A third type-Gestational diabetes mellitus (GDM)-is diagnosed in the second or third trimester of pregnancy and was not clearly overt diabetes prior to gestation (American Diabetes Association. Lifestyle management can enhance diabetes care and it includes diabetes self-management education and support (DSMES), medical nutrition therapy, physical activity, smoking cessation counselling, and psychosocial care. However, health systems cannot control all the factors that influence a person's overall health, as physicians are unable to check regularly what their patients eat or whether they properly adhere to their medications. Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role. Patients and care providers should work together to optimize lifestyle aspects through the entire care process. Telemedicine "healing at a distance" signifies the use of information and communication technology to improve patient outcomes by increasing access to care and medical information. Using mobile and wireless technologies to achieve health objectives (mHealth) can universally transform health services' delivery. Mobile phones can easily reach population since they have exceeded other communication technologies in Low and middle-Income countries (LMICs). The results of the present study will help the policy-makers in the MOHP to understand the importance of creating healthcare systems that meet the needs of patients and providers and develop DSMES strategy with the help of pharmacist educator and using innovative mobile phone technology.
Detailed description
The global prevalence of diabetes among adults aged over 18 years old has increased from 4.7% in 1980 to 8.5% in 2014 (Mathers \& Loncar, 2006; WHO, 2018b). The World Health Organization (WHO) estimates that diabetes was the seventh leading cause of death in 2016 (WHO, 2016; WHO, 2018a). Current national statistics show that around 17% of all Egyptian adults have diabetes, and over 60% of diabetics receive no treatment (Eastern Mediterranean Regional Office (EMRO), 2016). According to the WHO, there will be 6,726,000 cases of diabetes in Egypt by 2030 (WHO, 2000).
Almost 45% of patients with T2D cannot achieve adequate glycemic control (HbA1c <7%). Poor medication adherence in T2D is a common public health problem and is associated with poor glycemic control, increased morbidity and mortality, and increased costs of outpatient care, emergency room visits, hospitalization, and managing complications of diabetes (Polonsky \& Henry, 2016).
Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role (Shane-McWhorter et al., 2009). Patients and care providers should work together to optimize lifestyle aspects through the entire care process (Abaza \& Marschollek, 2017).
In Egypt, the Ministry of Health and Population (MOHP) is partially implementing diabetes education, mostly in outpatient clinics via educational meetings or counselling with physicians/ nurses. Patients often report difficulty sticking to healthy lifestyles. They are also liable to forget or ignore their physician's advice after leaving the clinic. Therefore, they need an educational method that can easily reach them to make knowledgeable patients and save the physician's critical time (Abaza \& Marschollek, 2017).
According to the Ministry of Communications and Information Technology (MCIT) in Egypt, up to October 2019, there were 95.25 million mobile subscriptions as opposed to 8.72 million fixed-line subscriptions (Ministry of Communication and Information Technology [MCIT], 2019). Moreover, there were 38.67 million mobile internet users versus 7.17 million Asymmetric Digital Subscriber Line subscriptions in the same month; the mobile internet users could reflect the proportion of smartphone owners in the country (MCIT, 2019). In contrary to mobile internet or smartphone applications, short message service (SMS) can provide a simple way of communication reaching a larger population since almost all types of mobile phones support them (Abaza \& Marschollek, 2017).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental; non-randomized, pre-test, post-test control group design.
| Arm | Type | Receives |
|---|---|---|
| SMS Recipients | Experimental | Behavioral: Mobile Phone Short Message Service• Mobile phone SMSs will be sent to the intervention group with the aim of improving medication adherence and knowledge about diabetes, its complications, diet and physical activity. |
| Non-SMS Recipients | No intervention | –Control group with no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 years old and more.
- Diagnosed with T2D up to 15 years according to the American Diabetes Association (ADA) standards (ADA, 2018).
- With poorly controlled diabetes, (pre-intervention HbA1c values of 7% up to 10%).
- Registered in the selected primary health care (PHC) centers and living in Alexandria.
- Currently on oral medication therapy (if purchased from the center pharmacy) and able to afford the cost for 6 months treatment (if purchased from an external pharmacy).
Key exclusion criteria (1 listed)
- Patients with clinical conditions that might interfere with the study such as pregnancy, mental illness, poor eyesight, hearing or vocalization, visual, renal or liver impairment, other serious illness or co-morbidities requiring hospitalization.
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 |
|---|---|---|
| Mobile Phone Short Message ServiceSMS content will be adopted from the validated Arabic national and international diabetes educational materials (Centers for Disease Control (CDC), 2018; Diabetes Australia, 2004; Diabetes Queensland, 2012; Utah Diabetes Control Program, 2005). * The mobile phone SMSs will be pre-tested for clarity on a sample of 10 patients similar to the study population and their comments on the SMSs wording will be used to modify them to ensure acceptance. * The SMS will be sent to participants using the internet, open-source software for bulk messages and a local telephone network provider. * Patients will be encouraged to send messages/call the researcher for any queries encountered. | Behavioural | SMS Recipients |
Primary outcome
Glycemic Control
Time frame: Change from Baseline HbA1c level at 6 months.
To assess the effect of the intervention on patients with type 2 diabetes in terms of glycemic control (HbA1c level).
1 secondary outcome
Medication Adherence
Time frame: Change from Baseline Medication Adherence at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- SMS education for the promotion of diabetes self-management in low \& middle-income countries: a pilot randomized controlled trial in Egypt.Link provided by the sponsor.
- G\*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.Link provided by the sponsor.
- mHealth interventions to counter noncommunicable diseases in developing countries: still an uncertain promise.Link provided by the sponsor.
- Effectiveness of mobile phone short message service on diabetes mellitus management; the SMS-DM study.Link provided by the sponsor.
- Projections of global mortality and burden of disease from 2002 to 2030.Link provided by the sponsor.
- Use of mHealth systems and tools for non-communicable diseases in low- and middle-income Countries: a systematic review.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rehab A Rayan, PharmD principal investigator
High Institute of Public Health, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone Short Message Service in people with Diabetes Mellitus, Type 2, run by Alexandria University at 1 site in Egypt.
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 8 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2022. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic Control (time frame: Change from Baseline HbA1c level at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022; AzTrials last refreshed its copy on 2 Nov 2026.