Type 2 Diabetes MellitusTEACHNCT03724526
Text Messaging and Cardiovascular Health in Diabetes Mellitus
A study testing Text messaging in people with Type 2 Diabetes Mellitus, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 819 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years and over
- Patients with poorly controlled type 2 diabetes who are undergoing routine treatment (defined as HbA1c≥ 7% or HbA1c≥7.5% if combined with clinical cardiovascular disease) have at least one risk factor for other cardiovascular disease (SBP≥140 mmHg and/or DBP≥90 mmHg and/or low density lipoprotein cholesterol≥100mg/dL) or clinical atherosclerotic cardiovascular disease (acute coronary syndrome, ischemic stroke transient ischemic attack or peripheral arterial disease)
- Participants can provide written informed consent.
- Participants required access to a smartphone, and be able to receive and read text message.
Who cannot join
- Participants were in functional New York Heart Association class III or IV, and were on haemodialysis;
- Pregnant women or women planning to become pregnant
- Participants cannot be followed up for 12 months (due to health status or migration)
- Participants cannot provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)
The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.
Read the detailed description
Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol), and the proportion of participants with HbA1C <7% (<7.5% if with clinical CVD), BP<140/90 mm Hg, and LDL-cholesterol <100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Text messaging
- Keywords
- Diabetes Mellitus, cardiovascular disease, text message
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingBehavioural
Intervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week.
Control: The control group will receive the usual care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Text messaging | Experimental | Participates will receive regular 6 text messages per week for 12 months. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. Receives: Behavioral: Text messaging |
| Control | No intervention | Participates in control group will not receive text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.
Measured: 12 months
Secondary outcomes (8)
Change in glucose level measured by HbA1C level
Measured: 12 months
Change in Systolic blood pressure level
Measured: 12 months
Change in LDL-cholesterol level
Measured: 12 months
The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease)
Measured: 12 months
The proportion achieving levels of blood pressure <140/90 mm Hg
Measured: 12 months
The proportion achieving levels of LDL-cholesterol <100 mg/dL
Measured: 12 months
Change in Framingham Risk Score
Measured: 12 months
Change in ACC/AHA Risk Score of CVD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Nov 2018
- Primary completion22 Jun 2022
- Study completion30 Jul 2022
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijie Zhang, Nanfang Hospital, Southern Medical University
- Investigators
- Huijie Zhang, M.D.&Ph.D, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724526
- Sponsor's protocol ID
- NFEC-2018-117
- Acronym
- TEACH
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2018
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang PZ, Guo D, Liu CQ, Chen N, Liu JF, Lei XZ, Yang LJ, Liu YT, Li X, Huang JF, Du CM, Wang K, Mo W, Lin JY, Huang CS, Xu BY, Wei XY, Liu DY, Huang JL, Huang Y, Xue YM, Zeng YM, Liu SQ, Ma ZM, Zhang HJ. Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529762. doi: 10.1001/jamanetworkopen.2025.29762.
PubMed 40892411
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)
- ClinicalTrials.gov ID
- NCT03724526
- Acronym / sponsor ID
- TEACH / NFEC-2018-117
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, cardiovascular disease, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 30 Oct 2018 (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 purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.
Detailed description
Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol), and the proportion of participants with HbA1C <7% (<7.5% if with clinical CVD), BP<140/90 mm Hg, and LDL-cholesterol <100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care.
| Arm | Type | Receives |
|---|---|---|
| Intervention-Text messaging | Experimental | Behavioral: Text messagingParticipates will receive regular 6 text messages per week for 12 months. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. |
| Control | No intervention | –Participates in control group will not receive text messages. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 18 years and over
- Patients with poorly controlled type 2 diabetes who are undergoing routine treatment (defined as HbA1c≥ 7% or HbA1c≥7.5% if combined with clinical cardiovascular disease) have at least one risk factor for other cardiovascular disease (SBP≥140 mmHg and/or DBP≥90 mmHg and/or low density lipoprotein cholesterol≥100mg/dL) or clinical atherosclerotic cardiovascular disease (acute coronary syndrome, ischemic stroke transient ischemic attack or peripheral arterial disease)
- Participants can provide written informed consent.
- Participants required access to a smartphone, and be able to receive and read text message.
Key exclusion criteria (4 listed)
- Participants were in functional New York Heart Association class III or IV, and were on haemodialysis;
- Pregnant women or women planning to become pregnant
- Participants cannot be followed up for 12 months (due to health status or migration)
- Participants cannot provide written informed consent.
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 |
|---|---|---|
| Text messagingIntervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Control: The control group will receive the usual care. | Behavioural | Intervention-Text messaging |
Primary outcome
Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.
Time frame: 12 months
8 secondary outcomes
Change in glucose level measured by HbA1C level
Time frame: 12 months
Change in Systolic blood pressure level
Time frame: 12 months
Change in LDL-cholesterol level
Time frame: 12 months
The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease)
Time frame: 12 months
The proportion achieving levels of blood pressure <140/90 mm Hg
Time frame: 12 months
The proportion achieving levels of LDL-cholesterol <100 mg/dL
Time frame: 12 months
Change in Framingham Risk Score
Time frame: 12 months
Change in ACC/AHA Risk Score of CVD
Time frame: 12 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 24 Oct 2022.
- Derived from this study: PubMed 40892411Zhang PZ, Guo D, Liu CQ, Chen N, Liu JF, Lei XZ, Yang LJ, Liu YT, Li X, Huang JF, Du CM, Wang K, Mo W, Lin JY, Huang CS, Xu BY, Wei XY, Liu DY, Huang JL, Huang Y, Xue YM, Zeng YM, Liu SQ, Ma ZM, Zhang HJ. Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529762. doi: 10.1001/jamanetworkopen.2025.29762.
- 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.
Huijie Zhang, M.D.&Ph.D principal investigator
Nanfang Hospital, Southern Medical 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 Text messaging in people with Type 2 Diabetes Mellitus, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 4 inclusion and 4 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 24 Oct 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 China. 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?
Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. (time frame: 12 months). 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 NCT03724526, 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 24 Oct 2022.