Diabete Type 2NCT07149311
Effectiveness of Diabetes Self-management Education on Glycaemic Control in Patients With T2DM
A study testing Intervention in people with Diabete Type 2, run by Komfo Anokye Teaching Hospital at 1 site in Ghana.
Trial summary
This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGhana
- Study dates
- 6 Feb 2024to 30 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM who are at least 18 years old without any co-morbidities requiring immediate hospitalisation
- HbA1c >7.9%
- Have access to a personal mobile phone and able to answer calls.
- Mentally stable, with no vision, verbal, or hearing impairments
- Have access a glucometer.
- Consents to the study
Who cannot join
- Other forms of DM such as type 1 DM or gestational diabetes.
- End-stage renal disease(eGFR<15ml/min)
- Anaemia
- History of stroke or other atherosclerotic cardiovascular diseases with impairment which makes the affected individual dependent on others for care giving and precludes self-care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Diabetes Self-management Education on Diabetes Control in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein cholesterol(LDL-C).
The main question this research seeks to answer is
Read more
- Does diabetes self-management education when combined with usual care improve glycaemic control when compared to usual care alone? Patients will be randomized into intervention and control groups. The intervention group will receive nurse led DSME using the American Association of diabetes educators 7 self care behaviour over a 6 month period. It will involve 3 monthly in-person sessions starting from the first day of recruitment as well as 2 weekly phone call sessions. This will be in addition to the usual care at the diabetes clinic.
The control group will receive usual diabetes care
Read the detailed description
This a randomized controlled parallel design among 74 Type 2 diabetes mellitus(T2DM) patients recruited from the Komfo Anokye Teaching Hospital Diabetes clinic.
The primary outcome is the mean change in HbA1c at 6 months
The secondary outcomes include:
- The mean change in FBG at 3 months
- The mean change in blood pressure at 6 months
- The mean change in body weight at 6 months
- The mean change in LDL-C at 6 month
STUDY PROTOCOL USUAL CARE The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills.
Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation.
Phone calls will be made to remind them of their clinic appointment for data collection.
THE INTERVENTION- DIABETES SELF-MANAGEMENT EDUCATION The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. An empowerment and interactive teaching model will be used with focus on behavioral assessment, goal-setting and problem-solving to promote autonomous self-regulation for better health and quality of life. A clinical sheet will be used while delivering the education to ensure that all core topics are covered.
For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model which focuses on: being active, healthy eating, monitoring blood glucose, healthy coping, reducing risks, problem solving and adherence to medication The participants are scheduled to attend a 1-hour individualized session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care . Subsequent consultations will be mainly feedback sessions, aimed at reviewing previously discussed matters, reinforcing key messages, addressing challenges and providing additional information.
- Conditions
- Diabete Type 2
- Being tested
- Intervention
- Keywords
- diabetes self management education, effectiveness, glycaemic control
- 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.
InterventionBehavioural
The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualised structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualised DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care
| Study group | Role | What they receive |
|---|---|---|
| Group that received only usual care (Control ) | No intervention | The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills. Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation. Phone calls will be made to remind them of their clinic appointment for data collection. |
| Group that received DSME plus usual care (Intervention) | Experimental | The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measuring the mean change in HbA1c at 6 months
Mean change in HbA1c
Measured: 6 months
Secondary outcomes (4)
Secondary outcome measuring the mean change in fasting blood glucose at 3 months
Mean change in fasting blood glucose 2) The mean change in blood pressure at 6 months 3) The mean change in body weight at 6 months 4) The mean change in LDL-C at 6 month
Measured: 3 months
Secondary outcome measuring the mean change in blood pressure at 6 months
Mean change in blood pressure
Measured: 6 months
Secondary outcome measuring the mean change in body weight at 6 months
Mean change in body weight
Measured: 6 months
Secondary outcome measuring the mean change in low density lipoprotein cholesterol at 6 months
Mean change in low density lipoprotein cholesterol
Measured: 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 Aug 2025
- Study start6 Feb 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Komfo Anokye Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kojo Awotwi Hutton-Mensah, Komfo Anokye Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149311
- Sponsor's protocol ID
- KATHIRB/AP/106/23
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diabetes Self-management Education on Diabetes Control in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07149311
- Acronym / sponsor ID
- KATHIRB/AP/106/23
- Conditions
- Diabete Type 2
- Keywords
- diabetes self management education, effectiveness, glycaemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Komfo Anokye Teaching HospitalUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 29 Aug 2025 (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.
This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein cholesterol(LDL-C).
The main question this research seeks to answer is
- Does diabetes self-management education when combined with usual care improve glycaemic control when compared to usual care alone? Patients will be randomized into intervention and control groups. The intervention group will receive nurse led DSME using the American Association of diabetes educators 7 self care behaviour over a 6 month period. It will involve 3 monthly in-person sessions starting from the first day of recruitment as well as 2 weekly phone call sessions. This will be in addition to the usual care at the diabetes clinic.
The control group will receive usual diabetes care
Detailed description
This a randomized controlled parallel design among 74 Type 2 diabetes mellitus(T2DM) patients recruited from the Komfo Anokye Teaching Hospital Diabetes clinic.
The primary outcome is the mean change in HbA1c at 6 months
The secondary outcomes include:
- The mean change in FBG at 3 months
- The mean change in blood pressure at 6 months
- The mean change in body weight at 6 months
- The mean change in LDL-C at 6 month
STUDY PROTOCOL USUAL CARE The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills.
Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation.
Phone calls will be made to remind them of their clinic appointment for data collection.
THE INTERVENTION- DIABETES SELF-MANAGEMENT EDUCATION The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. An empowerment and interactive teaching model will be used with focus on behavioral assessment, goal-setting and problem-solving to promote autonomous self-regulation for better health and quality of life. A clinical sheet will be used while delivering the education to ensure that all core topics are covered.
For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model which focuses on: being active, healthy eating, monitoring blood glucose, healthy coping, reducing risks, problem solving and adherence to medication The participants are scheduled to attend a 1-hour individualized session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care . Subsequent consultations will be mainly feedback sessions, aimed at reviewing previously discussed matters, reinforcing key messages, addressing challenges and providing additional information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group that received only usual care (Control ) | No intervention | –The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills. Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation. Phone calls will be made to remind them of their clinic appointment for data collection. |
| Group that received DSME plus usual care (Intervention) | Experimental | Behavioral: InterventionThe intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with T2DM who are at least 18 years old without any co-morbidities requiring immediate hospitalisation
- HbA1c >7.9%
- Have access to a personal mobile phone and able to answer calls.
- Mentally stable, with no vision, verbal, or hearing impairments
- Have access a glucometer.
Key exclusion criteria (4 listed)
- Other forms of DM such as type 1 DM or gestational diabetes.
- End-stage renal disease(eGFR<15ml/min)
- Anaemia
- History of stroke or other atherosclerotic cardiovascular diseases with impairment which makes the affected individual dependent on others for care giving and precludes self-care
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 |
|---|---|---|
| InterventionThe intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualised structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualised DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care | Behavioural | Group that received DSME plus usual care (Intervention) |
Primary outcome
Primary outcome measuring the mean change in HbA1c at 6 months
Time frame: 6 months
Mean change in HbA1c
4 secondary outcomes
Secondary outcome measuring the mean change in fasting blood glucose at 3 months
Time frame: 3 months
Secondary outcome measuring the mean change in blood pressure at 6 months
Time frame: 6 months
Secondary outcome measuring the mean change in body weight at 6 months
Time frame: 6 months
Secondary outcome measuring the mean change in low density lipoprotein cholesterol at 6 months
Time frame: 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 29 Aug 2025.
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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 Intervention in people with Diabete Type 2, run by Komfo Anokye Teaching Hospital at 1 site in Ghana.
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 6 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 29 Aug 2025. 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 Ghana. 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?
Primary outcome measuring the mean change in HbA1c at 6 months (time frame: 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 29 Aug 2025.