Type 2 DiabetesNCT05629117
Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes
A study testing Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education and Personalized Diabetes Text Messaging (DB-TEXT) in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes. This study is an assessor-blinded, three-arm, parallel randomized controlled trial. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education and Personalized Diabetes Text Messaging (DB-TEXT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Dec 2022to 30 Jul 2023
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months)
- Participants ho were 17 years or older (the legal age to provide informed consent in Indonesia)
- having their own mobile phone
Who cannot join
- People who could not read or write Indonesian
- Had medical diagnostic with cognitive impairments
- Psychiatric disorders, or were diagnosed with cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes: A Randomized Controlled Trial
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes. This study is an assessor-blinded, three-arm, parallel randomized controlled trial. Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study. The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.
Read the detailed description
Background :
Our early component network meta-analysis (CNMA) study showed that short message service (SMS) and peer support education (PSE) are the most effective component of digitally assisted intervention in improving HbA1C level in type 2 diabetes.
Purposes:
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes.
Methods:
This study is an assessor-blinded, three-arm, parallel randomized controlled trial (RCT). Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study.The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.
- Conditions
- Type 2 Diabetes
- Being tested
- Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education, Personalized Diabetes Text Messaging (DB-TEXT)
- Keywords
- Diabetes Text Messaging (DB-TEXT), peer support education, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support EducationBehavioural
Patients who are assigned to the DB-TEXT+PSE group will receive personalized short text message services twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Furthermore, they will receive the peer support education weekly from the peer supporter by telephone during three months
Personalized Diabetes Text Messaging (DB-TEXT)Behavioural
Personalized Diabetes Text Messaging (DB-TEXT)
| Study group | Role | What they receive |
|---|---|---|
| Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education Group | Experimental | Patients who are assigned to the DB-TEXT+PSE group will receive personalized short text message services twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Additionally they will receive peer support education weekly during three month. Receives: Behavioral: Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education |
| Personalized Diabetes Text Messaging (DB-TEXT) Group | Active comparator | The participants in the Personalized DB-TEXT group will receive the personalized short text message twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Receives: Behavioral: Personalized Diabetes Text Messaging (DB-TEXT) |
| Control Group | No intervention | Health education related to diabetes management will be provided to the control group once a month during three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1C level
HbA1C level of participants will be assessed in the laboratory test in hospital
Measured: at baseline, 3 months, 6 months
Changes in fasting blood glucose level
Fasting blood glucose level of participants will be assessed using glucometer
Measured: at baseline, 3 months, 6 months
Changes in Lipids level including total cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) , and triglycerides
The total cholesterol, LDL, HDL, and triglycerides of the participants will assessed in the laboratory test in hospital
Measured: at baseline, 3 months, 6 months
Changes in Blood Pressure Level including Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Blood pressure of participants will be measured using sphygmomanometer
Measured: at baseline, 3 months, 6 months
Secondary outcomes (4)
Changes in Fatigue
Fatigue levels of participants will be assessed using a Multidimensional Fatigue Inventory-20 (MFI-20). MFI-20 contains 20 items and five subscales, general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.
Measured: At baseline, 3 months, 6 months
Changes in Sleep Quality
Sleep quality of the participants will be measured using The Pittsburgh Sleep Quality Index (PSQI). PSQI assesses self-reported sleep quality and sleep disturbance in the preceding month.
Measured: At baseline, 3 months, 6 months
Changes in Depression
The depression levels of participants will be assessed using the Beck Depression Inventory-Second Edition (BDI-II). There are 21 items on the BDI-II that measure subjective depression symptoms over the preceding 2 weeks
Measured: At baseline, 3 months, 6 months
Changes in Quality of Life
Quality of life of the participants will be measured using the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI). DQoL-BCI contains 15 questions. Using a Likert scale of 5 points, participants can assess their satisfaction with each DQoL-BCI item (1=Very Dissatisfied/All the Time, 2=Moderately Dissatisfied/Sometimes, 3=Neither/Sometimes, and 4=Moderately Satisfied/Very Seldom).
Measured: At baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start26 Dec 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629117
- Sponsor's protocol ID
- No.1738/UN25.8/KEPK/DL/2022
- Status last verified
- Aug 2023
- First submitted
- 11 Nov 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05629117
- Acronym / sponsor ID
- No.1738/UN25.8/KEPK/DL/2022
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Text Messaging (DB-TEXT), peer support education, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 29 Nov 2022 (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 this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes. This study is an assessor-blinded, three-arm, parallel randomized controlled trial. Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study. The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.
Detailed description
Background :
Our early component network meta-analysis (CNMA) study showed that short message service (SMS) and peer support education (PSE) are the most effective component of digitally assisted intervention in improving HbA1C level in type 2 diabetes.
Purposes:
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes.
Methods:
This study is an assessor-blinded, three-arm, parallel randomized controlled trial (RCT). Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study.The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education Group | Experimental | Behavioral: Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support EducationPatients who are assigned to the DB-TEXT+PSE group will receive personalized short text message services twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Additionally they will receive peer support education weekly during three month. |
| Personalized Diabetes Text Messaging (DB-TEXT) Group | Active comparator | Behavioral: Personalized Diabetes Text Messaging (DB-TEXT)The participants in the Personalized DB-TEXT group will receive the personalized short text message twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). |
| Control Group | No intervention | –Health education related to diabetes management will be provided to the control group once a month during three months |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months)
- Participants ho were 17 years or older (the legal age to provide informed consent in Indonesia)
- having their own mobile phone
Key exclusion criteria (3 listed)
- People who could not read or write Indonesian
- Had medical diagnostic with cognitive impairments
- Psychiatric disorders, or were diagnosed with cancer
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 |
|---|---|---|
| Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support EducationPatients who are assigned to the DB-TEXT+PSE group will receive personalized short text message services twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Furthermore, they will receive the peer support education weekly from the peer supporter by telephone during three months | Behavioural | Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education Group |
| Personalized Diabetes Text Messaging (DB-TEXT)Personalized Diabetes Text Messaging (DB-TEXT) | Behavioural | Personalized Diabetes Text Messaging (DB-TEXT) Group |
Primary outcome
Changes in HbA1C level
Time frame: at baseline, 3 months, 6 months
HbA1C level of participants will be assessed in the laboratory test in hospital
Changes in fasting blood glucose level
Time frame: at baseline, 3 months, 6 months
Fasting blood glucose level of participants will be assessed using glucometer
Changes in Lipids level including total cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) , and triglycerides
Time frame: at baseline, 3 months, 6 months
The total cholesterol, LDL, HDL, and triglycerides of the participants will assessed in the laboratory test in hospital
Changes in Blood Pressure Level including Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Time frame: at baseline, 3 months, 6 months
Blood pressure of participants will be measured using sphygmomanometer
4 secondary outcomes
Changes in Fatigue
Time frame: At baseline, 3 months, 6 months
Changes in Sleep Quality
Time frame: At baseline, 3 months, 6 months
Changes in Depression
Time frame: At baseline, 3 months, 6 months
Changes in Quality of Life
Time frame: At baseline, 3 months, 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 4 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education and Personalized Diabetes Text Messaging (DB-TEXT) in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.
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 3 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 4 Aug 2023. 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 Taiwan. 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?
Changes in HbA1C level (time frame: at baseline, 3 months, 6 months). The study lists 4 primary outcomes in all. 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 4 Aug 2023.