Type 2 DiabetesCLICKNCT06925217
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
A study testing CamAPS HX and Standard insulin therapy with CGM in people with Type 2 Diabetes and Chronic Kidney Disease Stage 3, run by Heba Al-Alwan at 2 sites in Switzerland.
Trial summary
The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease Stage 3
- What is being tested?
- CamAPS HX and Standard insulin therapy with CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 16 Jun 2025to May 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
- Informed consent signed by the subject
- Age 18 years and older
- Type 2 diabetes diagnosed for at least 12 months
- Treatment with insulin therapy for at least 6 months
- CKD defined either as an eGFR 30-59 ml/min/1.73m² or presence of albuminuria > 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR > 30 ml/min/1.73m². CKD must be present for at least 6 months.
- HbA1c < 12% based on a venous blood sample from the screening visit
Show all 9Show fewer
- Receiving treatment with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication/intolerance to receiving these therapies
- Willing to wear study devices and follow study instructions
- Capable of giving an informed consent
Who cannot join
- Type 1 diabetes
- Current use of insulin pump
- Current use of any closed-loop system
- Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc.
- Known or suspected allergy against insulin
- Pregnancy, planned pregnancy, or breast feeding
Show all 22Show fewer
- Severe visual impairment
- Severe hearing impairment
- Two or more episodes of severe hypoglycemia in the last 6 months
- Medically documented allergy towards the adhesive (glue) of plasters
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
- Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction
- History of renal transplantation requiring ongoing immunosuppressive therapy
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the investigation, e.g. due to language problems
- Incapacity to give informed consent
- Contra-indication to undergo MR-imaging according to a standard checklist such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia.
- Subject refuses to be informed of incidental findings related to their health discovered during imaging or other study-related exams
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- Previous enrolment into the current investigation
- Enrolment of the PI, his/her family members, employees and other dependent persons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Heba Al-Alwan, MD, PhD, +4179 556 27 98, heba.al-alwan@chuv.ch
Heba Al-Alwan, MD, PhD
- Recruiting
CHUV
Lausanne
Heba Alwan, 41795562798, heba.al-alwan@chuv.ch
About this study
Official title: The Effect of Fully Closed-loop Insulin Delivery on Renal Oxygenation in People With Type 2 Diabetes and Chronic Kidney Disease: an Open-label, Single-center, Randomized Two-arm Parallel Trial
The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease.
This is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics.
The primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol/L). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.
Read the detailed description
Recruitment:
The investigators aim to recruit 76 participants through the Service of Endocrinology, Diabetes, and Metabolism and through the Nephrology and Hypertension Service at the University Hospital of Lausanne (CHUV), as well as other outpatient diabetes clinics in the canton of Vaud if needed.
Screening visit:
Potential participants will have the opportunity to ask questions and will give written informed consent if interested in participating in the study. A screening blood test, a urine analysis, and urine pregnancy test will be done at this visit.
Baseline visit:
The baseline assessment will consist of a medical history, height and weight measurement, waist-hip ratio measurement and blood pressure measurement. Participants will also answer questionnaires to assess patient-reported outcome measures and undergo a renal MRI. A masked glucose sensor will be worn for 14 days.
Visit 3:
Randomisation will occur in a 1:1 ratio using REDCap to the use of fully closed-loop therapy or standard insulin therapy with continuous glucose monitoring (CGM) for 26 weeks once the participants complete the masked CGM period. Participants will attend the research center and receive training on study devices (closed-loop system or CGM) and study devices will be initiated.
Visit 4:
Participants will attend the research center around two days after initiation of the study arm to discuss potential issues related to use of study devices. This visit can also be conducted by phone.
Telephone contacts:
Participants in both arms will be contacted by telephone 1 week after initiation of the study arm, as well as at one, two, four, and five months after initiation of study arm to discuss any issues with devices, adverse events, or changes to medications.
Visit 5 (3 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed.
Visit 6 (6 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed. A renal MRI will be repeated at this visit. Study devices will be returned, and participants will resume their usual diabetes care.
Patient-reported outcomes:
Patient-reported outcome measures will be assessed using five validated questionnaires: Diabetes Distress Scale, Hypoglycemia Attitudes and Behavior Scale, Audit of Diabetes-Dependent Quality of Life, Diabetes Treatment Satisfaction Questionnaire - status version, Diabetes Treatment Satisfaction Questionnaire - change version
Safety outcomes:
Safety outcomes will include the number of severe hypoglycemia episodes, as well as the nature and severity of other adverse events including serious adverse events.
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease Stage 3
- Being tested
- CamAPS HX, Standard insulin therapy with CGM
- Keywords
- closed-loop, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS HXDevice
The CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump.
Standard insulin therapy with CGMDevice
Participants will continue their standard insulin therapy with a Freestyle Libre 3 CGM
| Study group | Role | What they receive |
|---|---|---|
| Fully closed-loop insulin delivery (CamAPS HX) | Experimental | The CamAPS HX closed-loop system will consist of :
* mylife Ypsopump insulin pump (Ypsomed, Switzerland)
* FreeStyle Libre 3 CGM (Abbott, USA)
* Cambridge model predictive control algorithm on a smartphone (CamAPS, UK)
* Cloud upload system to review CGM/insulin data Receives: Device: CamAPS HX |
| Standard insulin therapy with CGM | Active comparator | Participants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA). Receives: Device: Standard insulin therapy with CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical renal tissue oxygenation (R2*)
Measured using BOLD-MRI
Measured: at 26 weeks
Secondary outcomes (19)
Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Glycated hemoglobin
Measured: at 26 weeks
Proportion of time spent above target glucose (>10.0mmol/l)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Mean sensor glucose
Sensor glucose metric measured in mmol/l
Measured: over 26 weeks
Non-inferiority for time spent below target glucose (<3.9mmol/L)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Standard deviation of sensor glucose
Sensor glucose metric measured in mmol/L
Measured: over 26 weeks
Coefficient of variation of sensor glucose
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Proportion of time spent below target glucose (<3.5mmol/L)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Proportion of time spent below target glucose (<3.0mmol/L)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Proportion of time spent above target glucose (>13.9mmol/l)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Proportion of time spent above target glucose (>16.7mmol/l)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Proportion of time spent above target glucose (>20.0mmol/l)
Sensor glucose metric measured as a percentage
Measured: over 26 weeks
Per-kidney renal perfusion (ml/min)
MRI-assessed outcome
Measured: at 26 weeks
Kidney inflammation (T1, msec)
MRI-assessed outcome
Measured: at 26 weeks
Medullary renal tissue oxygenation (R2*)
measured using BOLD-MRI
Measured: at 26 weeks
R2* slope
measured using BOLD-MRI
Measured: at 26 weeks
Serum creatinine (umol/l)
Measured: at 26 weeks
Serum urea (umol/l)
Measured: at 26 weeks
Urine albumin/creatinine ratio (ACR)
Measured: at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start16 Jun 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heba Al-Alwan
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Institute of Primary Health Care (BIHAM), Switzerland
- Responsible party
- Sponsor-investigator, Heba Al-Alwan, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925217
- Sponsor's protocol ID
- CLICK
- Acronym
- CLICK
- Status last verified
- Feb 2026
- First submitted
- 30 Mar 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data can be requested by other researchers 6 months following publication (data available upon reasonable request). To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fully Closed-loop Insulin Delivery on Renal Oxygenation in People With Type 2 Diabetes and Chronic Kidney Disease: an Open-label, Single-center, Randomized Two-arm Parallel Trial
- ClinicalTrials.gov ID
- NCT06925217
- Acronym / sponsor ID
- CLICK / CLICK
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease Stage 3
- Keywords
- closed-loop, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Heba Al-AlwanUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Institute of Primary Health Care (BIHAM), Switzerland
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Apr 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.
The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease.
This is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics.
The primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol/L). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.
Detailed description
Recruitment:
The investigators aim to recruit 76 participants through the Service of Endocrinology, Diabetes, and Metabolism and through the Nephrology and Hypertension Service at the University Hospital of Lausanne (CHUV), as well as other outpatient diabetes clinics in the canton of Vaud if needed.
Screening visit:
Potential participants will have the opportunity to ask questions and will give written informed consent if interested in participating in the study. A screening blood test, a urine analysis, and urine pregnancy test will be done at this visit.
Baseline visit:
The baseline assessment will consist of a medical history, height and weight measurement, waist-hip ratio measurement and blood pressure measurement. Participants will also answer questionnaires to assess patient-reported outcome measures and undergo a renal MRI. A masked glucose sensor will be worn for 14 days.
Visit 3:
Randomisation will occur in a 1:1 ratio using REDCap to the use of fully closed-loop therapy or standard insulin therapy with continuous glucose monitoring (CGM) for 26 weeks once the participants complete the masked CGM period. Participants will attend the research center and receive training on study devices (closed-loop system or CGM) and study devices will be initiated.
Visit 4:
Participants will attend the research center around two days after initiation of the study arm to discuss potential issues related to use of study devices. This visit can also be conducted by phone.
Telephone contacts:
Participants in both arms will be contacted by telephone 1 week after initiation of the study arm, as well as at one, two, four, and five months after initiation of study arm to discuss any issues with devices, adverse events, or changes to medications.
Visit 5 (3 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed.
Visit 6 (6 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed. A renal MRI will be repeated at this visit. Study devices will be returned, and participants will resume their usual diabetes care.
Patient-reported outcomes:
Patient-reported outcome measures will be assessed using five validated questionnaires: Diabetes Distress Scale, Hypoglycemia Attitudes and Behavior Scale, Audit of Diabetes-Dependent Quality of Life, Diabetes Treatment Satisfaction Questionnaire - status version, Diabetes Treatment Satisfaction Questionnaire - change version
Safety outcomes:
Safety outcomes will include the number of severe hypoglycemia episodes, as well as the nature and severity of other adverse events including serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully closed-loop insulin delivery (CamAPS HX) | Experimental | Device: CamAPS HXThe CamAPS HX closed-loop system will consist of : * mylife Ypsopump insulin pump (Ypsomed, Switzerland) * FreeStyle Libre 3 CGM (Abbott, USA) * Cambridge model predictive control algorithm on a smartphone (CamAPS, UK) * Cloud upload system to review CGM/insulin data |
| Standard insulin therapy with CGM | Active comparator | Device: Standard insulin therapy with CGMParticipants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent signed by the subject
- Age 18 years and older
- Type 2 diabetes diagnosed for at least 12 months
- Treatment with insulin therapy for at least 6 months
- CKD defined either as an eGFR 30-59 ml/min/1.73m² or presence of albuminuria > 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR > 30 ml/min/1.73m². CKD must be present for at least 6 months.
Key exclusion criteria (22 listed)
- Type 1 diabetes
- Current use of insulin pump
- Current use of any closed-loop system
- Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc.
- Known or suspected allergy against insulin
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 |
|---|---|---|
| CamAPS HXThe CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump. | Device | Fully closed-loop insulin delivery (CamAPS HX) |
| Standard insulin therapy with CGMParticipants will continue their standard insulin therapy with a Freestyle Libre 3 CGM | Device | Standard insulin therapy with CGM |
Primary outcome
Cortical renal tissue oxygenation (R2*)
Time frame: at 26 weeks
Measured using BOLD-MRI
19 secondary outcomes
Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l)
Time frame: over 26 weeks
Glycated hemoglobin
Time frame: at 26 weeks
Proportion of time spent above target glucose (>10.0mmol/l)
Time frame: over 26 weeks
Mean sensor glucose
Time frame: over 26 weeks
Non-inferiority for time spent below target glucose (<3.9mmol/L)
Time frame: over 26 weeks
Standard deviation of sensor glucose
Time frame: over 26 weeks
Coefficient of variation of sensor glucose
Time frame: over 26 weeks
Proportion of time spent below target glucose (<3.5mmol/L)
Time frame: over 26 weeks
Proportion of time spent below target glucose (<3.0mmol/L)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>13.9mmol/l)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>16.7mmol/l)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>20.0mmol/l)
Time frame: over 26 weeks
Per-kidney renal perfusion (ml/min)
Time frame: at 26 weeks
Kidney inflammation (T1, msec)
Time frame: at 26 weeks
Medullary renal tissue oxygenation (R2*)
Time frame: at 26 weeks
R2* slope
Time frame: at 26 weeks
Serum creatinine (umol/l)
Time frame: at 26 weeks
Serum urea (umol/l)
Time frame: at 26 weeks
Urine albumin/creatinine ratio (ACR)
Time frame: at 26 weeks
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 12 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data can be requested by other researchers 6 months following publication (data available upon reasonable request). To gain access, data requestors will need to sign a data access agreement.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS HX and Standard insulin therapy with CGM in people with Type 2 Diabetes and Chronic Kidney Disease Stage 3, run by Heba Al-Alwan at 2 sites in Switzerland.
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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 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?
Contact Heba Al-Alwan, MD, PhD (+4179 556 27 98, heba.al-alwan@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical renal tissue oxygenation (R2*) (time frame: at 26 weeks). 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 12 Feb 2026.