Type2 Diabetes MellitusNCT04733612
The Effects of Short Message Notifications on Middle-Aged Diabetic Patients
A study testing Informative messages in people with Type2 Diabetes Mellitus, run by Istanbul University.
Trial summary
The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Informative messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2016to 26 Feb 2018
- 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 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years
- Being aged between 40 and 64 years old,
- Is treated for a minimum of 1 year with at least one oral antidiabetic drug.
Who cannot join
- Clinical diagnosis of T2DM for less than 1 year or more than 10 years.
- Those who have had surgery or a cardiac event in the last 3 months or during the investigation.
- Those under 40 and over 64 years of age.
- Patients with T2DM that have not been treated with oral antidiabetic medication.
- Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.
About this study
Official title: Effects of Short-Message Notifications on Medication Adherence, Physical Activity and Fasting Blood Glucose Control and Correlation of These With the Health-Related Quality of Life in Mid-aged Diabetic Patients
The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology.
Read the detailed description
The study investigates T2DM patients who have not had surgery or cardiac event in the last 3 months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10 years and oral antidiabetic therapy for at least 1 The study design is a single-blinded randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul University Medical Faculty Hospital.
Patients randomly assigned to the intervention group, in addition to traditional treatment received three to four informative SMS messages per week during the 6-month period, while the control group was followed in accordance with the traditional treatment schedule.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Informative messages
- Keywords
- Diabetes mellitus, Public health
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative messagesOther
In addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months.
The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones.
| Study group | Role | What they receive |
|---|---|---|
| SMS Group | Experimental | In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period Receives: Other: Informative messages |
| Control Group | No intervention | Followed in accordance with the traditional treatment schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Measured: Beginning
Change from Baseline Fasting blood glucose at 3 months
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Measured: 3 months after beginning
Change from Baseline Fasting blood glucose at 6 months
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Measured: 6 months after beginning
Glycated hemoglobin A (HbA1c)
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method.
Measured: Beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Measured: 3 months after beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Measured: 6 months after beginning
Physical Activity level
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at the beginning of the study.
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Measured: Beginning
Change from Baseline Physical Activity at 3 months
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at at 3 months after the beginning of the study.
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Measured: 3 months from beginning
Change from Baseline Physical Activity at 6 months
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the change in physical activity level of the participants at at 6 months after the beginning of the study.
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Measured: 6 months from beginning
Drug Adherence
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment.
If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Measured: Beginning
Change from Baseline Drug Adherence at 3 months
The Morisky Medication Adherence Scale was used to assess the compliance of patients with drug treatment.
If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Measured: 3 months after beginning
Change from Baseline Drug Adherence at 6 months
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment.
If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Measured: 6 months after beginning
Quality of Life Assessed by SF-36v2
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Measured: Beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Measured: 3 months after beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Measured: 6 months after beginning
Secondary outcomes (20)
Baseline blood pressure
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Measured: Beginning
Change from Baseline blood pressure at 3 months
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Measured: 3 months after beginning
Change from Baseline blood pressure at 6 months
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Measured: 6 months after beginning
Baseline heart rate
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Measured: Beginning
Change from Baseline heart rate at 3 months
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Measured: 3 Months After Beginning
Change from Baseline heart rate at 6 months
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Measured: 6 Months After Beginning
Baseline Body Mass Index
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula:
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Measured: Beginning
Change from Baseline Body Mass Index at 3 months
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula:
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Measured: 3 months after Beginning
Change from Baseline Body Mass Index at 6 months
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula:
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Measured: 6 months after Beginning
Baseline body fat ratios
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Measured: Beginning
Change from Baseline Body Fat Ratios at 3 Months
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Measured: 3 Months After Beginning
Change from Baseline Body Fat Ratios at 6 Months
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Measured: 6 Months After Beginning
Baseline waist/hip ratio
The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them.
Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major.
Waist/hip ratio (WHR) were were calculated as follows
waist/hip ratio= waist circumference / hip circumference
Measured: Beginning
Change from Baseline waist/hip ratio at 3 Months
The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them.
Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major.
Waist/hip ratio (WHR) were were calculated as follows
waist/hip ratio= waist circumference / hip circumference
Measured: 3 Months after Beginning
Baseline Diet and Nutritional Habits
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Measured: Beginning
Change from Baseline Diet and Nutritional Habits at 3 months
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Measured: 3 Months after Beginning
Change from Baseline Diet and Nutritional Habits at 6 months
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Measured: 6 Months after Beginning
Baseline Energy Intake
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Measured: Beginning
Change from Baseline Energy Intake at 3 months
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Measured: 3 months after Beginning
Change from Baseline Energy Intake at 6 months
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Measured: 6 months after Beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start30 Jun 2016
- Primary completion20 Dec 2017
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Tahirbegolli, Istanbul University
- Investigators
- Suphi Vehid, Prof. Dr., Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733612
- Sponsor's protocol ID
- 20135
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the start date of the study is before 18 January 2017, individual participant data (IPD) will only be available to other researchers on a reasonable request.
Publications
Tahirbegolli B, Tahirbegolli IA, Cakmak R, Idiz C, Cavdar S, Bagdemir E, Vehid S. Effects of Short-message Notifications on Type 2 Diabetes Management in Middle-aged Turkish Patients: A Randomized Trial. Balkan Med J. 2022 Mar 14;39(2):161-162. doi: 10.4274/balkanmedj.galenos.2021.2021-10-47. No abstract available.
PubMed 35330570
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-Message Notifications on Medication Adherence, Physical Activity and Fasting Blood Glucose Control and Correlation of These With the Health-Related Quality of Life in Mid-aged Diabetic Patients
- ClinicalTrials.gov ID
- NCT04733612
- Acronym / sponsor ID
- 20135
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, Public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 2 Feb 2021 (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.
The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology.
Detailed description
The study investigates T2DM patients who have not had surgery or cardiac event in the last 3 months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10 years and oral antidiabetic therapy for at least 1 The study design is a single-blinded randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul University Medical Faculty Hospital.
Patients randomly assigned to the intervention group, in addition to traditional treatment received three to four informative SMS messages per week during the 6-month period, while the control group was followed in accordance with the traditional treatment schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Group | Experimental | Other: Informative messagesIn addition to traditional treatment received three to four informative SMS messages per week during the 6-month period |
| Control Group | No intervention | –Followed in accordance with the traditional treatment schedule |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years
- Being aged between 40 and 64 years old,
- Is treated for a minimum of 1 year with at least one oral antidiabetic drug.
Key exclusion criteria (5 listed)
- Clinical diagnosis of T2DM for less than 1 year or more than 10 years.
- Those who have had surgery or a cardiac event in the last 3 months or during the investigation.
- Those under 40 and over 64 years of age.
- Patients with T2DM that have not been treated with oral antidiabetic medication.
- Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.
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 |
|---|---|---|
| Informative messagesIn addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months. The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones. | Other | SMS Group |
Primary outcome
Fasting blood glucose
Time frame: Beginning
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Change from Baseline Fasting blood glucose at 3 months
Time frame: 3 months after beginning
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Change from Baseline Fasting blood glucose at 6 months
Time frame: 6 months after beginning
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Glycated hemoglobin A (HbA1c)
Time frame: Beginning
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method.
Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months
Time frame: 3 months after beginning
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months
Time frame: 6 months after beginning
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Physical Activity level
Time frame: Beginning
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Change from Baseline Physical Activity at 3 months
Time frame: 3 months from beginning
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at at 3 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Change from Baseline Physical Activity at 6 months
Time frame: 6 months from beginning
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the change in physical activity level of the participants at at 6 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Drug Adherence
Time frame: Beginning
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Change from Baseline Drug Adherence at 3 months
Time frame: 3 months after beginning
The Morisky Medication Adherence Scale was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Change from Baseline Drug Adherence at 6 months
Time frame: 6 months after beginning
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Quality of Life Assessed by SF-36v2
Time frame: Beginning
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months
Time frame: 3 months after beginning
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months
Time frame: 6 months after beginning
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
20 secondary outcomes
Baseline blood pressure
Time frame: Beginning
Change from Baseline blood pressure at 3 months
Time frame: 3 months after beginning
Change from Baseline blood pressure at 6 months
Time frame: 6 months after beginning
Baseline heart rate
Time frame: Beginning
Change from Baseline heart rate at 3 months
Time frame: 3 Months After Beginning
Change from Baseline heart rate at 6 months
Time frame: 6 Months After Beginning
Baseline Body Mass Index
Time frame: Beginning
Change from Baseline Body Mass Index at 3 months
Time frame: 3 months after Beginning
Change from Baseline Body Mass Index at 6 months
Time frame: 6 months after Beginning
Baseline body fat ratios
Time frame: Beginning
Change from Baseline Body Fat Ratios at 3 Months
Time frame: 3 Months After Beginning
Change from Baseline Body Fat Ratios at 6 Months
Time frame: 6 Months After Beginning
Baseline waist/hip ratio
Time frame: Beginning
Change from Baseline waist/hip ratio at 3 Months
Time frame: 3 Months after Beginning
Baseline Diet and Nutritional Habits
Time frame: Beginning
Change from Baseline Diet and Nutritional Habits at 3 months
Time frame: 3 Months after Beginning
Change from Baseline Diet and Nutritional Habits at 6 months
Time frame: 6 Months after Beginning
Baseline Energy Intake
Time frame: Beginning
Change from Baseline Energy Intake at 3 months
Time frame: 3 months after Beginning
Change from Baseline Energy Intake at 6 months
Time frame: 6 months after Beginning
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 2 Feb 2021.
- Derived from this study: PubMed 35330570Tahirbegolli B, Tahirbegolli IA, Cakmak R, Idiz C, Cavdar S, Bagdemir E, Vehid S. Effects of Short-message Notifications on Type 2 Diabetes Management in Middle-aged Turkish Patients: A Randomized Trial. Balkan Med J. 2022 Mar 14;39(2):161-162. doi: 10.4274/balkanmedj.galenos.2021.2021-10-47. No abstract available.
- Individual participant dataSharing planned: No. Since the start date of the study is before 18 January 2017, individual participant data (IPD) will only be available to other researchers on a reasonable request.
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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.
Suphi Vehid, Prof. Dr. study chair
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing Informative messages in people with Type2 Diabetes Mellitus, run by Istanbul University.
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 3 inclusion and 5 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Fasting blood glucose (time frame: Beginning). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733612, which also lists 1 linked publication.
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 2 Feb 2021.