Type 2 Diabetes Mellitus (DM)ComBaCaL DMNCT05743387
Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho
A study testing DM care package and Referral to the responsible health facility in people with Type 2 Diabetes Mellitus (DM), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (DM)
- What is being tested?
- DM care package and Referral to the responsible health facility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 May 2023to 31 Dec 2027
- 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
- Participant of the ComBaCaL cohort study (signed informed consent available)
- Living with DM, defined as reporting intake of antidiabetic medication or being newly diagnosed during screening via standard diagnostic algorithm
Who cannot join
- Known type 1 diabetes mellitus
- Reported pregnancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
University of Basel, Division of Clinical Epidemiology
Basel, 4051
About this study
Official title: Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho Protocol for a Cluster-randomized Trial Within the ComBaCaL Cohort Study (ComBaCaL DM TwiC)
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs).
The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho.
In this DM TwiC, the effect, safety and feasibility of a community-based DM care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated DM by lay VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.
Read the detailed description
Globally, 9.3% of the adult population or 436 million individuals were estimated to be living with diabetes in 2019. Until 2045 this number is expected to increase by more than 50% to over 700 million. Four out of five people affected by diabetes are currently living in low- and middle-income countries (LMICs). Over 90% of all diabetes cases are due to type 2 diabetes (DM) which is also the main driver of the projected increase in overall diabetes cases. The increase in DM prevalence is caused by ageing populations and changing lifestyles with decreasing levels of physical activity and higher caloric diets and associated obesity.
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs).
In this trial, using the Trials within Cohorts (TwiCs) approach, it will be analyzed whether an LHW-led model could be capacitated to safely and effectively provide first-line management (including oral antidiabetic, lipid-lowering treatment and lifestyle counselling) at community-level.
In villages randomized to the intervention arm, lay Village Health Workers (VHWs) operating within the existing Ministry of Health (MoH) village health worker system will be capacitated to screen for and diagnose DM, to provide lifestyle counselling, to prescribe and to monitor first-line antidiabetic and lipid-lowering treatment for uncomplicated DM and to provide treatment support for complicated DM, supported by a tailored clinical decision support application in their villages.
The control group consists of people diagnosed with DM living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where VHWs will only screen for and diagnose DM with subsequent standardized counselling and referral to the closest health facility if DM is present, but no village-based prescriptions.
The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho.
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Being tested
- DM care package, Referral to the responsible health facility
- Keywords
- Lesotho, Southern Africa, Diabetes, Community-based care, Community Health Workers, Non-communicable diseases
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM care packageOther
DM care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated DM and treatment support and regular check-ups for complicated DM at village-level. Guidance will be provided via the CDS application. In case of complicated disease referral to the closest health facility for further management.
Referral to the responsible health facilityOther
VHWs will refer participants to the responsible health facility for therapeutic management. The CDS application supports clinical decision making and documentation for screening, diagnosis and referral, but not prescription/provision and monitoring of antidiabetic or lipid-lowering medication for uncomplicated DM patients or treatment support for complicated DM patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention villages | Active comparator | In the intervention villages, VHWs will offer
* a DM care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated DM and treatment support and regular check-ups for complicated DM at village-level according to clinical algorithms based on international guidelines for primary healthcare management of DM and the updated Lesotho Standard Treatment Guidelines.
* Direct guidance for treatment initiation, drug prescription, counselling and monitoring will be provided via the CDS application.
* In case of complicated disease (i.e. if treatment targets are not reached with metformin alone), unclear diagnosis, relevant comorbidities or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further management. Receives: Other: DM care package |
| Control villages | Active comparator | In control villages, VHWs will refer participants to the responsible health facility for therapeutic management after enrolment and baseline assessment. Receives: Other: Referral to the responsible health facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean HbA1c (in percent)
Mean HbA1c (in percent)
Measured: 12 months after enrolment
Secondary outcomes (10)
Change in 10-year CVD risk estimated
Change in 10-year CVD risk estimated using the World Health Organization (WHO) CVD risk prediction tool
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Mean HbA1c (in percent)
Mean HbA1c (in percent)
Measured: 6 months after enrolment
Change in mean fasting blood glucose (FBG) (mmol/l)
Change in mean fasting blood glucose (FBG) (mmol/l)
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in proportion of participants with an HbA1c below 8%
Change in proportion of participants with an HbA1c below 8%
Measured: 6 and 12 months after enrolment
Change in proportion of participants with an FBG below 7 mmol/l
Change in proportion of participants with an FBG below 7 mmol/l
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in number of CVD risk factors
Change in number of CVD risk factors (such as smoking status, BMI, abdominal circumference, blood lipid status, blood pressure, dietary habits and physical activity)
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment
Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Engagement in care: Change in proportion of participants who are engaged in care
Change in proportion of participants who are engaged in care, defined as reporting intake of antidiabetic medication as per prescription of a healthcare provider or reaching treatment targets without intake of medication
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in self-reported adherence to antidiabetic medication
Change in self-reported adherence to antidiabetic medication
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Measured: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start13 May 2023
- Primary completion23 Mar 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (DM)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial nested within the ComBaCaL cohort study following a trial within cohort (TwiC) approach. 50% of the villages being part of the overarching ComBaCaL cohort will be randomized stratified by district and access to health facility to receive the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
- Responsible party
- Sponsor
- Investigators
- Niklaus Labhardt, Prof., Principal investigator, Division of Clinical Epidemiology, University Hospital BaselAlain Amstutz, MD, Principal investigator, Division of Clinical Epidemiology, University Hospital Basel, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743387
- Sponsor's protocol ID
- AO_2022-00077; am23Labhardt
- Acronym
- ComBaCaL DM
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium. * The statistical report for the primary and key secondary endpoints and the code to produce it will be published together with the data set.
Publications
Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Kohler M, Haldemann MI, Raber F, Chitja M, Manthabiseng M, Khomolishoele M, Mota M, Bane M, Sematle PM, Makabateng R, Mphunyane M, Phaaroe S, Basler D, Kindler K, Seelig E, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC). Trials. 2023 Oct 24;24(1):688. doi: 10.1186/s13063-023-07729-8.
PubMed 37875943Gerber F, Gupta R, Sanchez-Samaniego G, Lejone TI, Tahirsylaj T, Raeber F, Saavedra EB, Esquivel-Valdes I, Chitja M, Molulela M, Khomolishoele M, Mota M, Bane M, Masike S, Sematle MP, Mofokeng M, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Seelig E, Chammartin F, Labhardt ND, Amstutz A. Community health worker-led versus facility-based type 2 diabetes care in rural Lesotho: a cluster-randomized trial within the ComBaCaL cohort study. BMC Med. 2026 May 22;24(1):400. doi: 10.1186/s12916-026-04943-4.
PubMed 42174613
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho Protocol for a Cluster-randomized Trial Within the ComBaCaL Cohort Study (ComBaCaL DM TwiC)
- ClinicalTrials.gov ID
- NCT05743387
- Acronym / sponsor ID
- ComBaCaL DM / AO_2022-00077; am23Labhardt
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Keywords
- Lesotho, Southern Africa, Diabetes, Community-based care, Community Health Workers, Non-communicable diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
- Study start
- 13 May 2023 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2023 (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 cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs).
The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho.
In this DM TwiC, the effect, safety and feasibility of a community-based DM care package (which includes the offer of first-line oral antidiabetic and lipid-lowering treatment for uncomplicated DM by lay VHWs in comparison to facility-based care after community-based screening and diagnosis) will be evaluated.
Detailed description
Globally, 9.3% of the adult population or 436 million individuals were estimated to be living with diabetes in 2019. Until 2045 this number is expected to increase by more than 50% to over 700 million. Four out of five people affected by diabetes are currently living in low- and middle-income countries (LMICs). Over 90% of all diabetes cases are due to type 2 diabetes (DM) which is also the main driver of the projected increase in overall diabetes cases. The increase in DM prevalence is caused by ageing populations and changing lifestyles with decreasing levels of physical activity and higher caloric diets and associated obesity.
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay village health workers (VHWs).
In this trial, using the Trials within Cohorts (TwiCs) approach, it will be analyzed whether an LHW-led model could be capacitated to safely and effectively provide first-line management (including oral antidiabetic, lipid-lowering treatment and lifestyle counselling) at community-level.
In villages randomized to the intervention arm, lay Village Health Workers (VHWs) operating within the existing Ministry of Health (MoH) village health worker system will be capacitated to screen for and diagnose DM, to provide lifestyle counselling, to prescribe and to monitor first-line antidiabetic and lipid-lowering treatment for uncomplicated DM and to provide treatment support for complicated DM, supported by a tailored clinical decision support application in their villages.
The control group consists of people diagnosed with DM living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where VHWs will only screen for and diagnose DM with subsequent standardized counselling and referral to the closest health facility if DM is present, but no village-based prescriptions.
The overall objective of the ComBaCaL cohort study and nested TwiCs is to assess the impact of eHealthsupported, lay-led chronic disease control measures in rural Lesotho.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial nested within the ComBaCaL cohort study following a trial within cohort (TwiC) approach. 50% of the villages being part of the overarching ComBaCaL cohort will be randomized stratified by district and access to health facility to receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention villages | Active comparator | Other: DM care packageIn the intervention villages, VHWs will offer * a DM care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated DM and treatment support and regular check-ups for complicated DM at village-level according to clinical algorithms based on international guidelines for primary healthcare management of DM and the updated Lesotho Standard Treatment Guidelines. * Direct guidance for treatment initiation, drug prescription, counselling and monitoring will be provided via the CDS application. * In case of complicated disease (i.e. if treatment targets are not reached with metformin alone), unclear diagnosis, relevant comorbidities or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further management. |
| Control villages | Active comparator | Other: Referral to the responsible health facilityIn control villages, VHWs will refer participants to the responsible health facility for therapeutic management after enrolment and baseline assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant of the ComBaCaL cohort study (signed informed consent available)
- Living with DM, defined as reporting intake of antidiabetic medication or being newly diagnosed during screening via standard diagnostic algorithm
Key exclusion criteria (2 listed)
- Known type 1 diabetes mellitus
- Reported pregnancy
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 |
|---|---|---|
| DM care packageDM care package including lifestyle counselling, firstline antidiabetic (metformin) and lipid-lowering (statin) treatment for uncomplicated DM and treatment support and regular check-ups for complicated DM at village-level. Guidance will be provided via the CDS application. In case of complicated disease referral to the closest health facility for further management. | Other | Intervention villages |
| Referral to the responsible health facilityVHWs will refer participants to the responsible health facility for therapeutic management. The CDS application supports clinical decision making and documentation for screening, diagnosis and referral, but not prescription/provision and monitoring of antidiabetic or lipid-lowering medication for uncomplicated DM patients or treatment support for complicated DM patients. | Other | Control villages |
Primary outcome
Mean HbA1c (in percent)
Time frame: 12 months after enrolment
Mean HbA1c (in percent)
10 secondary outcomes
Change in 10-year CVD risk estimated
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Mean HbA1c (in percent)
Time frame: 6 months after enrolment
Change in mean fasting blood glucose (FBG) (mmol/l)
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in proportion of participants with an HbA1c below 8%
Time frame: 6 and 12 months after enrolment
Change in proportion of participants with an FBG below 7 mmol/l
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in number of CVD risk factors
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Linkage to care: Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Engagement in care: Change in proportion of participants who are engaged in care
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Change in self-reported adherence to antidiabetic medication
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Occurrence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
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 10 Sep 2026.
- Background: PubMed 37875943Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Kohler M, Haldemann MI, Raber F, Chitja M, Manthabiseng M, Khomolishoele M, Mota M, Bane M, Sematle PM, Makabateng R, Mphunyane M, Phaaroe S, Basler D, Kindler K, Seelig E, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC). Trials. 2023 Oct 24;24(1):688. doi: 10.1186/s13063-023-07729-8.
- Derived from this study: PubMed 42174613Gerber F, Gupta R, Sanchez-Samaniego G, Lejone TI, Tahirsylaj T, Raeber F, Saavedra EB, Esquivel-Valdes I, Chitja M, Molulela M, Khomolishoele M, Mota M, Bane M, Masike S, Sematle MP, Mofokeng M, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Seelig E, Chammartin F, Labhardt ND, Amstutz A. Community health worker-led versus facility-based type 2 diabetes care in rural Lesotho: a cluster-randomized trial within the ComBaCaL cohort study. BMC Med. 2026 May 22;24(1):400. doi: 10.1186/s12916-026-04943-4.
- Individual participant dataSharing planned: Yes. * An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium. * The statistical report for the primary and key secondary endpoints and the code to produce it will be published together with the data set.
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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.
Niklaus Labhardt, Prof. principal investigator
Division of Clinical Epidemiology, University Hospital Basel
Alain Amstutz, MD principal investigator
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DM care package and Referral to the responsible health facility in people with Type 2 Diabetes Mellitus (DM), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
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 2 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lesotho, Switzerland. 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?
Mean HbA1c (in percent) (time frame: 12 months after enrolment). 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 NCT05743387, which also lists 2 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 10 Sep 2026.