An interventional study of DM care package and Referral to the responsible health facility in Type 2 Diabetes Mellitus (DM), sponsored by University Hospital, Basel, Switzerland. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Health services research
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 252 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: DM care package
In control villages, VHWs will refer participants to the responsible health facility for therapeutic management after enrolment and baseline assessment.
Other: Referral to the responsible health facility
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.
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.
Mean HbA1c (in percent)
Mean HbA1c (in percent)
Time frame: 12 months after enrolment
Change in 10-year CVD risk estimated
Change in 10-year CVD risk estimated using the World Health Organization (WHO) CVD risk prediction tool
Time frame: 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Mean HbA1c (in percent)
Mean HbA1c (in percent)
Time frame: 6 months after enrolment
Change in mean fasting blood glucose (FBG) (mmol/l)
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%
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
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
Change in number of CVD risk factors (such as smoking status, BMI, abdominal circumference, blood lipid status, blood pressure, dietary habits and physical activity)
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
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
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
Time frame: 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
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)
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
Number of consultations (at a health facility and with the VHW)
Number of consultations at a health facility and with the VHW
Time frame: within 6, 12, 18, 24, 30, 36, 42 and 48 months after enrolment
Trajectory of participants between facility-based and community-based care in the intervention villages
Trajectory of participants between facility-based and community-based care in the intervention villages (i.e. number of participants accepting community-based care at baseline, number of people switching to facility-based care and back to community-based care
Time frame: during the study period (up to 48 months)
Proportion of participants with DM who stop drug treatment or interrupt drug treatment for more than three weeks or require a switch of drug treatment due to (perceived) adverse events (AEs)
Proportion of participants with DM who stop drug treatment or interrupt drug treatment for more than three weeks or require a switch of drug treatment due to (perceived) adverse events (AEs)
Time frame: within 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in proportion of participants who are reaching treatment targets (FBG <7 mmol/l) and are reporting no intake of antidiabetic medication in the two weeks prior to assessment
Change in proportion of participants who are reaching treatment targets (FBG \<7 mmol/l) and are reporting no intake of antidiabetic medication in the two weeks prior to assessment
Time frame: 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in proportion of participants accessing lipid-lowering medication
Change in proportion of participants accessing lipid-lowering medication
Time frame: 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in health system costs for the management of participants condition
Change in health system costs for the management of participants condition
Time frame: within 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in individual costs for participants for the management of their condition
Change in individual costs for participants for the management of their condition
Time frame: within 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in10-year CVD risk estimated using the Globorisk score
Change in10-year CVD risk estimated using the Globorisk score, a cardiovascular disease risk score that predicts risk of heart attack or stroke in healthy individuals for all countries in the world. It uses information on a person's country of residence, age, sex, smoking, diabetes, blood pressure and cholesterol to predict the chance that they would have a heart attack or stroke in the next 10 years.
Time frame: 6 and 12 months after enrolment
Change in10-year CVD risk estimated using the Framingham Risk Score
Change in10-year CVD risk estimated using the Framingham Risk Score, a sex-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. The Framingham Risk Score was first developed based on data obtained from the Framingham Heart Study.
Time frame: 6 and 12 months after enrolment
Quality of life (QOL) using the EQ-5D-5L instrument
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The QOL scores are summed so that a higher score indicates higher quality of life.
Time frame: 12 months after enrolment
Health beliefs using the Beliefs about Medicines Questionnaire (BMQ) adapted for people living with DM
The BMQl comprises two 4-item factors assessing beliefs that medicines are harmful, addictive, poisons which should not be taken continuously and that medicines are overused by doctors.The items are scored on a 5 point Likert scale with scores ranging from 4 to 20.
Time frame: 12 months after enrolment
Diabetes distress using the five item version of the "Problem Areas in Diabetes" (PAID-5) scale Problem Areas in Diabetes Scale-Five-item Short Form
Problem Areas in Diabetes Scale-Five-item Short Form. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.
Time frame: 12 months after enrolment
Change in dosage of antidiabetic medications prescribed by VHWs or healthcare professionals
Change in dosage of antidiabetic medications prescribed by VHWs or healthcare professionals
Time frame: 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
Change in dosage of lipid-lowering medications prescribed by VHWs or healthcare professionals
Change in dosage of lipid-lowering medications prescribed by VHWs or healthcare professionals
Time frame: 6, 12, 18, 14, 30, 36, 42 and 48 months after enrolment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Within 3 months after publication of primary results
Access criteria: Open access
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland →