Type 2 Diabetes Mellitus (T2DM)NCT06623006
Self Management of Type 2 Diabetes Using a Text Based Mobile Health (Mhealth) Intervention in Nepal
A study testing mobile health (mhealth) in people with Type 2 Diabetes Mellitus (T2DM), run by University of Huddersfield at 1 site in Nepal.
Trial summary
Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- mobile health (mhealth)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteNepal
- Study dates
- 16 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adults aged 18 years and above
- clinical diagnosis of type 2 diabetes
- participant who have a mobile phone and is able to read the message on their own or with the help of family members.
Who cannot join
- not physically or mentally able, not able to provide consent
- pregnant in case of female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self Management of Type 2 Diabetes Using a Co-designed Mobile Health (Mhealth) Intervention in Nepal: A Randomized Control Trial
Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. mhealth offers a cost-effective way to improve health outcomes with evidence supporting feasibility, acceptability and effectiveness in resource-limited settings like Nepal. However, while mhealth has shown promising results in promoting positive health behaviour and improving service utilization for chronic conditions, its potential for self-management of type 2 diabetes in Nepal is yet to be evaluated. This study thus aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes in Nepal.
Methods: This study is a 6 month, open-label, two-armed parallel group randomized control trial among 154 participants with type 2 diabetes. Participants will be randomly assigned to either intervention or control group on a 1:1 basis. The intervention group will receive a text based mhealth intervention (text messages) in addition to standard care while the control group will receive only standard care. Baseline data will be collected using a structured questionnaire. Follow up will be done 6 months after the intervention. The primary outcome of the study will be a difference in mean in the HbA1c level from baseline to follow up. The secondary outcomes include changes in diabetes self-care activities, self-efficacy, social-support, diabetes related stress, quality of life and acceptability of the intervention. An economic evaluation will be conducted using a patient perspective. Data will be analyzed using Stata version 13.0.
Read the detailed description
Background and rationale The number of people living with diabetes has increased globally and is on rapid rise among low and middle income countries (LMICs). In 2021, there were 537 million people living with diabetes and this number is expected to rise to 643 million by 2030 and 783 million by 2045. More than three in four adults with diabetes are living in LMICs. Diabetes accounted for 6.6 million deaths in 2021 and is a major cause of blindness, kidney failure, heart attack, stroke and lower limb amputation. Following the global trend, the prevalence of diabetes has been increasing in Nepal. The International Diabetes Federation (IDF) estimated a prevalence of 8.7% among Nepalese population and the proportion is to rise to 9.4% by 2045.
The burgeoning burden of disease may place serious challenges on the resource constrained national health system due to complications resulting from the disease, coupled with issues around service availability; readiness and limited awareness among the people living with diabetes.
Access to care is of utmost importance for people with diabetes in the course of their disease however, the availability and utilisation of diabetes care services vary across socio-economic and geographical distribution indicating challenges in accessing the diabetes care services. WHO STEPS survey Nepal 2019 reported about three-fourth (73.5%) of the people were not aware of their raised blood sugar. Despite being aware of their condition, about 6% were not on treatment. Similarly, only 70% of adults with raised blood sugar reported compliance to medications to control their blood sugar. In addition, public health facilities in Nepal are not ready to deal with the increasing burden of NCDs including diabetes in terms of qualified health staff, training, availability of equipment and medicines as well as availability of diabetes services in general.
Early diagnosis, treatment and self-management are essential for the prevention and control of the disease. Self-management refers to the activities and behaviour undertaken by the individuals to control and treat their conditions to improve their health outcomes with support from family members, friends and relatives and in consultation with health service providers. The American Association of Diabetes Educators (AADE) has identified seven self-care behaviours for successful and effective self-management of diabetes as healthy coping, healthy eating, being active, taking medication, monitoring, reducing risks and problem solving. Self-management has been proved to be cost effective through reduction in hospital admissions and health care costs. Besides, it is shown to improve HbA1c level and has a positive effect on other clinical, psychosocial, and behavioural aspects of diabetes along with improvement in quality of life by reducing onset and/or advancement of diabetes complications.
With the development of technology, the application of mobile health (mhealth) is becoming increasingly popular in the self-care of chronic diseases. mhealth interventions have been proved to be a therapeutic strategy that could improve the diabetes management despite their economic status. According to the National Population and Housing Census report 2021, about three-fourth (73%) of the households have at least some form of smartphone penetration and 37.9% household with internet access in Nepal.
In the resource limited countries like Nepal, mhealth technology can be a cost-effective approach to deliver care and improve the health outcomes. There are studies demonstrating the feasibility, acceptability and even effectiveness of mhealth in improving the health outcomes for hypertension in Nepal. There is also existing evidence of mhealth as an effective means to communicate health related information and supporting positive behaviour change in a short period of time. Despite availability of body of evidence on acceptability of mhealth in improving service utilization and health outcomes for chronic conditions, the application of behaviour change interventions through mhealth for self-management of diabetes is yet to be evaluated.
Objectives This study aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes using a co-designed approach in Nepal.
Objective 1: To determine effectiveness and cost effectiveness of text based mhealth intervention in improving self-management (HbA1c level, self-efficacy, perceived support, diabetes related stress, health related quality of life and self-care behaviors) Objective 2: To determine acceptability of a text based mhealth intervention in improving self-management among people with type 2 diabetes
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- mobile health (mhealth)
- Keywords
- type 2 diabetes, mhealth, self-management, Nepal
- 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.
mobile health (mhealth)Behavioural
The intervention will include a text-based mhealth component, designed using a behaviour change framework (Behaviour Change Wheel). The development process will be further informed by a formative research exploring perspectives of both health service providers and users on use of text based mhealth for supporting self-management in people with type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will be receive usual care they have been getting. At the end of the intervention, they will be provided with a leaflet that contains messages that was included in the mhealth intervention. |
| Intervention | Experimental | The intervention group will receive a text-based mhealth (text messages) in addition to standard care which they are used to receiving. Receives: Behavioral: mobile health (mhealth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level
change in mean HbA1c between intervention and control group from baseline to follow up (6 months after the intervention)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start16 Sep 2025
- Primary completion1 Dec 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Huddersfield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namuna Shrestha, University of Huddersfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623006
- Sponsor's protocol ID
- UHuddersfieldProtV000001
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Mar 9;8(3):e15419. doi: 10.2196/15419.
PubMed 32149712Bhandari B, Narasimhan P, Jayasuriya R, Vaidya A, Schutte AE. Effectiveness and Acceptability of a Mobile Phone Text Messaging Intervention to Improve Blood Pressure Control (TEXT4BP) among Patients with Hypertension in Nepal: A Feasibility Randomised Controlled Trial. Glob Heart. 2022 Feb 23;17(1):13. doi: 10.5334/gh.1103. eCollection 2022.
PubMed 35342691Xiong S, Berkhouse H, Schooler M, Pu W, Sun A, Gong E, Yan LL. Effectiveness of mHealth Interventions in Improving Medication Adherence Among People with Hypertension: a Systematic Review. Curr Hypertens Rep. 2018 Aug 7;20(10):86. doi: 10.1007/s11906-018-0886-7.
PubMed 30088110Wang Y, Min J, Khuri J, Xue H, Xie B, A Kaminsky L, J Cheskin L. Effectiveness of Mobile Health Interventions on Diabetes and Obesity Treatment and Management: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2020 Apr 28;8(4):e15400. doi: 10.2196/15400.
PubMed 32343253Lu X, Yang H, Xia X, Lu X, Lin J, Liu F, Gu D. Interactive Mobile Health Intervention and Blood Pressure Management in Adults. Hypertension. 2019 Sep;74(3):697-704. doi: 10.1161/HYPERTENSIONAHA.119.13273. Epub 2019 Jul 22.
PubMed 31327259Kitsiou S, Pare G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017.
PubMed 28249025Kang H, Park HA. A Mobile App for Hypertension Management Based on Clinical Practice Guidelines: Development and Deployment. JMIR Mhealth Uhealth. 2016 Feb 2;4(1):e12. doi: 10.2196/mhealth.4966.
PubMed 26839283Sukartini T, Nursalam N, Pradipta RO, Ubudiyah M. Potential Methods to Improve Self-management in Those with Type 2 Diabetes: A Narrative Review. Int J Endocrinol Metab. 2023 Jan 8;21(1):e119698. doi: 10.5812/ijem-119698. eCollection 2023 Jan.
PubMed 37038539Panagioti M, Richardson G, Small N, Murray E, Rogers A, Kennedy A, Newman S, Bower P. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014 Aug 27;14:356. doi: 10.1186/1472-6963-14-356.
PubMed 25164529American Association of Diabetes Educators. An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors(R). Diabetes Educ. 2020 Apr;46(2):139-160. doi: 10.1177/0145721719894903. Epub 2020 Jan 12.
PubMed 31928334Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-Management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. J Acad Nutr Diet. 2015 Aug;115(8):1323-34. doi: 10.1016/j.jand.2015.05.012. Epub 2015 Jun 5. No abstract available.
PubMed 26054423Adhikari B, Pandey AR, Lamichhane B, Kc SP, Joshi D, Regmi S, Giri S, Baral SC. Readiness of health facilities to provide services related to non-communicable diseases in Nepal: evidence from nationally representative Nepal Health Facility Survey 2021. BMJ Open. 2023 Jul 9;13(7):e072673. doi: 10.1136/bmjopen-2023-072673.
PubMed 37423630Upreti SR, Lohani GR, Magtymova A, Dixit LP. Strengthening policy and governance to address the growing burden of diabetes in Nepal. WHO South East Asia J Public Health. 2016 Apr;5(1):40-43. doi: 10.4103/2224-3151.206551.
PubMed 28604396Gyawali B, Ferrario A, van Teijlingen E, Kallestrup P. Challenges in diabetes mellitus type 2 management in Nepal: a literature review. Glob Health Action. 2016 Oct 18;9:31704. doi: 10.3402/gha.v9.31704. eCollection 2016.
PubMed 27760677Ghimire U, Shrestha N, Adhikari B, Mehata S, Pokharel Y, Mishra SR. Health system's readiness to provide cardiovascular, diabetes and chronic respiratory disease related services in Nepal: analysis using 2015 health facility survey. BMC Public Health. 2020 Jul 25;20(1):1163. doi: 10.1186/s12889-020-09279-z.
PubMed 32711487
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Management of Type 2 Diabetes Using a Co-designed Mobile Health (Mhealth) Intervention in Nepal: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06623006
- Acronym / sponsor ID
- UHuddersfieldProtV000001
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- type 2 diabetes, mhealth, self-management, Nepal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of HuddersfieldUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Oct 2024 (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.
Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. mhealth offers a cost-effective way to improve health outcomes with evidence supporting feasibility, acceptability and effectiveness in resource-limited settings like Nepal. However, while mhealth has shown promising results in promoting positive health behaviour and improving service utilization for chronic conditions, its potential for self-management of type 2 diabetes in Nepal is yet to be evaluated. This study thus aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes in Nepal.
Methods: This study is a 6 month, open-label, two-armed parallel group randomized control trial among 154 participants with type 2 diabetes. Participants will be randomly assigned to either intervention or control group on a 1:1 basis. The intervention group will receive a text based mhealth intervention (text messages) in addition to standard care while the control group will receive only standard care. Baseline data will be collected using a structured questionnaire. Follow up will be done 6 months after the intervention. The primary outcome of the study will be a difference in mean in the HbA1c level from baseline to follow up. The secondary outcomes include changes in diabetes self-care activities, self-efficacy, social-support, diabetes related stress, quality of life and acceptability of the intervention. An economic evaluation will be conducted using a patient perspective. Data will be analyzed using Stata version 13.0.
Detailed description
Background and rationale The number of people living with diabetes has increased globally and is on rapid rise among low and middle income countries (LMICs). In 2021, there were 537 million people living with diabetes and this number is expected to rise to 643 million by 2030 and 783 million by 2045. More than three in four adults with diabetes are living in LMICs. Diabetes accounted for 6.6 million deaths in 2021 and is a major cause of blindness, kidney failure, heart attack, stroke and lower limb amputation. Following the global trend, the prevalence of diabetes has been increasing in Nepal. The International Diabetes Federation (IDF) estimated a prevalence of 8.7% among Nepalese population and the proportion is to rise to 9.4% by 2045.
The burgeoning burden of disease may place serious challenges on the resource constrained national health system due to complications resulting from the disease, coupled with issues around service availability; readiness and limited awareness among the people living with diabetes.
Access to care is of utmost importance for people with diabetes in the course of their disease however, the availability and utilisation of diabetes care services vary across socio-economic and geographical distribution indicating challenges in accessing the diabetes care services. WHO STEPS survey Nepal 2019 reported about three-fourth (73.5%) of the people were not aware of their raised blood sugar. Despite being aware of their condition, about 6% were not on treatment. Similarly, only 70% of adults with raised blood sugar reported compliance to medications to control their blood sugar. In addition, public health facilities in Nepal are not ready to deal with the increasing burden of NCDs including diabetes in terms of qualified health staff, training, availability of equipment and medicines as well as availability of diabetes services in general.
Early diagnosis, treatment and self-management are essential for the prevention and control of the disease. Self-management refers to the activities and behaviour undertaken by the individuals to control and treat their conditions to improve their health outcomes with support from family members, friends and relatives and in consultation with health service providers. The American Association of Diabetes Educators (AADE) has identified seven self-care behaviours for successful and effective self-management of diabetes as healthy coping, healthy eating, being active, taking medication, monitoring, reducing risks and problem solving. Self-management has been proved to be cost effective through reduction in hospital admissions and health care costs. Besides, it is shown to improve HbA1c level and has a positive effect on other clinical, psychosocial, and behavioural aspects of diabetes along with improvement in quality of life by reducing onset and/or advancement of diabetes complications.
With the development of technology, the application of mobile health (mhealth) is becoming increasingly popular in the self-care of chronic diseases. mhealth interventions have been proved to be a therapeutic strategy that could improve the diabetes management despite their economic status. According to the National Population and Housing Census report 2021, about three-fourth (73%) of the households have at least some form of smartphone penetration and 37.9% household with internet access in Nepal.
In the resource limited countries like Nepal, mhealth technology can be a cost-effective approach to deliver care and improve the health outcomes. There are studies demonstrating the feasibility, acceptability and even effectiveness of mhealth in improving the health outcomes for hypertension in Nepal. There is also existing evidence of mhealth as an effective means to communicate health related information and supporting positive behaviour change in a short period of time. Despite availability of body of evidence on acceptability of mhealth in improving service utilization and health outcomes for chronic conditions, the application of behaviour change interventions through mhealth for self-management of diabetes is yet to be evaluated.
Objectives This study aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes using a co-designed approach in Nepal.
Objective 1: To determine effectiveness and cost effectiveness of text based mhealth intervention in improving self-management (HbA1c level, self-efficacy, perceived support, diabetes related stress, health related quality of life and self-care behaviors) Objective 2: To determine acceptability of a text based mhealth intervention in improving self-management among people with type 2 diabetes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will be receive usual care they have been getting. At the end of the intervention, they will be provided with a leaflet that contains messages that was included in the mhealth intervention. |
| Intervention | Experimental | Behavioral: mobile health (mhealth)The intervention group will receive a text-based mhealth (text messages) in addition to standard care which they are used to receiving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults aged 18 years and above
- clinical diagnosis of type 2 diabetes
- participant who have a mobile phone and is able to read the message on their own or with the help of family members.
Key exclusion criteria (2 listed)
- not physically or mentally able, not able to provide consent
- pregnant in case of female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile health (mhealth)The intervention will include a text-based mhealth component, designed using a behaviour change framework (Behaviour Change Wheel). The development process will be further informed by a formative research exploring perspectives of both health service providers and users on use of text based mhealth for supporting self-management in people with type 2 diabetes. | Behavioural | Intervention |
Primary outcome
Change in HbA1c level
Time frame: six months
change in mean HbA1c between intervention and control group from baseline to follow up (6 months after the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 32149712Ni Z, Atluri N, Shaw RJ, Tan J, Khan K, Merk H, Ge Y, Shrestha S, Shrestha A, Vasudevan L, Karmacharya B, Yan LL. Evaluating the Feasibility and Acceptability of a Mobile Health-Based Female Community Health Volunteer Program for Hypertension Control in Rural Nepal: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020 Mar 9;8(3):e15419. doi: 10.2196/15419.
- Background: PubMed 35342691Bhandari B, Narasimhan P, Jayasuriya R, Vaidya A, Schutte AE. Effectiveness and Acceptability of a Mobile Phone Text Messaging Intervention to Improve Blood Pressure Control (TEXT4BP) among Patients with Hypertension in Nepal: A Feasibility Randomised Controlled Trial. Glob Heart. 2022 Feb 23;17(1):13. doi: 10.5334/gh.1103. eCollection 2022.
- Background: PubMed 30088110Xiong S, Berkhouse H, Schooler M, Pu W, Sun A, Gong E, Yan LL. Effectiveness of mHealth Interventions in Improving Medication Adherence Among People with Hypertension: a Systematic Review. Curr Hypertens Rep. 2018 Aug 7;20(10):86. doi: 10.1007/s11906-018-0886-7.
- Background: PubMed 32343253Wang Y, Min J, Khuri J, Xue H, Xie B, A Kaminsky L, J Cheskin L. Effectiveness of Mobile Health Interventions on Diabetes and Obesity Treatment and Management: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2020 Apr 28;8(4):e15400. doi: 10.2196/15400.
- Background: PubMed 31327259Lu X, Yang H, Xia X, Lu X, Lin J, Liu F, Gu D. Interactive Mobile Health Intervention and Blood Pressure Management in Adults. Hypertension. 2019 Sep;74(3):697-704. doi: 10.1161/HYPERTENSIONAHA.119.13273. Epub 2019 Jul 22.
- Background: PubMed 28249025Kitsiou S, Pare G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017.
- Background: PubMed 26839283Kang H, Park HA. A Mobile App for Hypertension Management Based on Clinical Practice Guidelines: Development and Deployment. JMIR Mhealth Uhealth. 2016 Feb 2;4(1):e12. doi: 10.2196/mhealth.4966.
- Background: PubMed 37038539Sukartini T, Nursalam N, Pradipta RO, Ubudiyah M. Potential Methods to Improve Self-management in Those with Type 2 Diabetes: A Narrative Review. Int J Endocrinol Metab. 2023 Jan 8;21(1):e119698. doi: 10.5812/ijem-119698. eCollection 2023 Jan.
- Background: PubMed 25164529Panagioti M, Richardson G, Small N, Murray E, Rogers A, Kennedy A, Newman S, Bower P. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014 Aug 27;14:356. doi: 10.1186/1472-6963-14-356.
- Background: PubMed 31928334American Association of Diabetes Educators. An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors(R). Diabetes Educ. 2020 Apr;46(2):139-160. doi: 10.1177/0145721719894903. Epub 2020 Jan 12.
- Background: PubMed 26054423Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-Management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. J Acad Nutr Diet. 2015 Aug;115(8):1323-34. doi: 10.1016/j.jand.2015.05.012. Epub 2015 Jun 5. No abstract available.
- Background: PubMed 37423630Adhikari B, Pandey AR, Lamichhane B, Kc SP, Joshi D, Regmi S, Giri S, Baral SC. Readiness of health facilities to provide services related to non-communicable diseases in Nepal: evidence from nationally representative Nepal Health Facility Survey 2021. BMJ Open. 2023 Jul 9;13(7):e072673. doi: 10.1136/bmjopen-2023-072673.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 mobile health (mhealth) in people with Type 2 Diabetes Mellitus (T2DM), run by University of Huddersfield at 1 site in Nepal.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. 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 Nepal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in HbA1c level (time frame: six 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 NCT06623006, which also lists 18 linked publications.
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 May 2026.