DialysisNCT06330194
Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
A study testing 2nd Generation Automated Insulin Delivery (AID) system in people with Dialysis and Chronic Kidney Disease, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dialysis, Chronic Kidney Disease, Diabetes Mellitus, Type 2
- What is being tested?
- 2nd Generation Automated Insulin Delivery (AID) system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Apr 2024to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial-related procedures are performed
- Type 1 diabetes of at least 1-year duration or insulin requiring type 2 diabetes (Total insulin dose should be below 200 IE per day)
- Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis).
- Subject must be willing and able to comply with trial protocol
- HbA1c <91 mmol/mol (10.5%)
- All participants will require to have internet or mobile phone access enabling upload of the AID system data to cloud based software.
Who cannot join
- History of ketoacidosis within the past 6 months
- Moderate to severe cognitive impairment
- Major allergy to tape/ adhesives
- Women who are pregnant or planning pregnancy
- Life-expectancy to <6 months
- Major psychiatric history
Show all 10Show fewer
- Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines)
- Treatment with non-insulin glucose lowering therapies may not be used on dialysis participants (with the exception of GLP1 agonists used in preparation for transplantation)
- Systemic steroid treatment within 4 weeks (stable doses of steroids >8 weeks allowed)
- Visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Control With a Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).
The main objective is:
Read more
- To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease
Secondary objectives are:
- To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population
Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.
Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels.
Read the detailed description
Dialysis patients with diabetes have a very short life expectancy likely caused by a high incidence of co-morbidities combined with an increased risk of hypoglycaemia and poor glycaemic control. In the past decades various diabetes technologies have revolutionised treatment, primarily in type 1 diabetes, but have also shown effect in type 2 diabetes. The Automated Insulin Delivery (AID) system combines continuous glucose monitoring (CGM) with an insulin pump that automatically infuse short-acting insulin subcutaneously and has shown remarkable results in improving glucose levels. We hypothesise that the AID system can lead to a substantial improvement in glycaemic control for patients receiving haemodialysis (HD), peritoneal dialysis (PD) and patients with chronic kidney disease (CKD) stage 3b to 5 (not on dialysis).
The primary objective is to determine if the AID system is superior in regulating glucose levels, in people living with type 1 and type 2 diabetes, receiving HD, PD or having advanced CKD, compared with usual care. Secondary objectives are to evaluate the impact on life quality, incidence of hypoglycaemia and if this treatment is feasible for this population
This prospective, open-label, two-stage randomized-crossover study is conducted at the Department of Nephrology, Rigshospitalet Copenhagen and Steno Diabetes Center Copenhagen. The study is performed in collaboration with six Australian centres (St Vincent's Melbourne, Royal Melbourne, Austin, Cairns Base, Flinders, and Canberra Hospitals).
A total of 15 participants will be recruited in Copenhagen, with participants evenly distributed across the three disease categories (HD, PD, and advanced CKD). Data collected from Copenhagen will be pooled with data obtained from the Australian centers.
Participants entering the study will have a four-to-six-week run-in phase with diabetes education (carbohydrate counting, inserting of CGM etc). Training will consist of three sessions of 2-4 hours with a dedicated diabetes nurse. During the run-in phase three weeks of unblinded CGM will be performed to assess baseline glucose levels. All participants will be randomized 1:1 to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of control (usual care) with cross over at the end of the first eight weeks.
The trial will be conducted in compliance with the Good Clinical Practice (GCP) guidelines, and written informed consent will be obtained before any trial activities are performed. The project including a plan for the handling of personal information will be approved by the Danish Data Protection Agency before initiation. If necessary, the Danish Medicines Agency and the responsible GCP unit will be granted access to journals, documents, and other materials relevant to the project. All participants will be assigned with a subject number and will be recorded on data sheets. Only tubes will appear with subject number and trial ID. Information on full name and social security and subject numbers will be stored separately.
- Conditions
- Dialysis, Chronic Kidney Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hemodialysis, Peritoneal Dialysis
- Being tested
- 2nd Generation Automated Insulin Delivery (AID) system
- Keywords
- Insulin Infusion Systems, Continuous Glucose Monitoring, Randomized Controlled Trial, Equipment Safety, Glycemic Control, Time-in-range
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2nd Generation Automated Insulin Delivery (AID) systemDevice
Also called Medtronic MiniMed 780G
The AID system will initially commence delivery by insulin pump post-randomisation without the AID in operation and with predictive low glucose suspend activated for a period of two weeks. Once safety has been established, the autocorrect function can be activated and the setpoint reduced to 5.5 mmol/L. Throughout the study insulin pump uploads will be reviewed twice weekly initially and at least weekly thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 2nd Generation Automated Insulin Delivery system (Medtronic MiniMed 780G) Receives: Device: 2nd Generation Automated Insulin Delivery (AID) system |
| Control Group | No intervention | Usual care consisting of participants current insulin-treatment (either multiple daily injection with insulin or traditional insulin pump therapy with manual determination of insulin dosing) and real-time CGM if already used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in sensor glucose target range (3.9-10.0 mmol/L)
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Secondary outcomes (34)
Proportion of time spent <2.8 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.0 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.3 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.9 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent 3.9-7.8
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >10.0 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >13.9 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >16.7 mmol/L
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Glucose variability (SD and coefficient of variation)
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Mean glucose
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
HbA1c
Blood sample
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes
Assessed by 3 continuous weeks of CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia
Hospital presentations with either of the above
Measured: Week 0-22
eGFR (estimated glomerular filtration rate)
Based on serum creatinine measurements, using the CKD-EPI equation. Only measured in patients from the CKD-group
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Potassium pre-dialysis
Blood sample. Only measured in patients from the HD-group
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Urine albumine-to-creatinine ratio
Urine sample. Only measured in patients from the CKD-group
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Actigraph Metrics for sleep architecture
Used concurrently with the CGM
Measured: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Sleep diary
Measured: Week 6-22
Proportion of time Automode is active
Registered through uploads from insulin pump in the intervention arm
Measured: Weekly assessed: week 6-22
Diabetic ketoacidosis
Measured: Week 0-22
Severe hypoglycemia
Requiring third party assistance
Measured: Week 0-22
Serious Adverse Event
Measured: Week 0-22
Unanticipated Serious Adverse Device Event
Measured: Week 0-22
Satisfaction with diabetes treatment
Questionnaire: The Diabetes Treatment Satisfaction Questionnaire status [DTSQs]
Measured: Enrollment visit: week 0; end of phase 1: week 14; end of phase 2: week 22
Satisfaction with diabetes treatment
Questionnaire: The Diabetes Treatment Satisfaction Questionnaire control version [DTSQc]
Measured: End of phase 1: week 14; end of phase 2: week 22
Fear of hypoglycaemia
Questionnaire: Hypoglycaemia Fear Survey [HFS-II]
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Hypoglycaemia awareness
Questionnaire: Gold Score and Clarke Score
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Diabetes distress
Questionnaire: Problem Areas in Diabetes [PAID]
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Sleep Quality
Questionnaire: Pittsburgh Sleep Quality Index [PSQI]
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Cognitive function
Questionnaire: Montreal Cognitive Assessment (MOCA)
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Sarcopenia
SARC-F questionnaire
Measured: End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Semi-structured interview
Influence of kidney disease on diabetes management and experience with the AID. Only performed in intervention arm.
Measured: End of phase 1: week 14; end of phase 2: week 22
Health-related quality of life
Questionnaire: EQ-5D
Measured: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Frailty
Questionnaire: Fried Frailty
Measured: End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Apr 2024
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies 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
- Crossover
- Model description
- Design: Prospective, open-label, two-stage randomised-crossover study. Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5). Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels. All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks. CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Tobias Bomholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Tobias Bomholt, MD, PhD, Principal investigator, Department of Nephrology, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330194
- Sponsor's protocol ID
- AID-study
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu JC, Meyer-Olesen CL, Halim B, Vogrin S, Christensen MB, Apostolopoulos J, Bomholt T, MacIsaac RJ, Lee P, Trawley S, Cohen N, Fourlanos S, Stranks S, Jenkins AJ, Ekinci E, Hornum M, Norgaard K, O'Neal DN. The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease. Diabetologia. 2026 Aug;69(8):2168-2181. doi: 10.1007/s00125-026-06732-3. Epub 2026 May 11.
PubMed 42108331
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
- Glucose Control With a Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
- ClinicalTrials.gov ID
- NCT06330194
- Acronym / sponsor ID
- AID-study
- Conditions
- Dialysis, Chronic Kidney Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hemodialysis, Peritoneal Dialysis
- Keywords
- Insulin Infusion Systems, Continuous Glucose Monitoring, Randomized Controlled Trial, Equipment Safety, Glycemic Control, Time-in-range
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 26 Mar 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.
The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).
The main objective is:
- To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease
Secondary objectives are:
- To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population
Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.
Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels.
Detailed description
Dialysis patients with diabetes have a very short life expectancy likely caused by a high incidence of co-morbidities combined with an increased risk of hypoglycaemia and poor glycaemic control. In the past decades various diabetes technologies have revolutionised treatment, primarily in type 1 diabetes, but have also shown effect in type 2 diabetes. The Automated Insulin Delivery (AID) system combines continuous glucose monitoring (CGM) with an insulin pump that automatically infuse short-acting insulin subcutaneously and has shown remarkable results in improving glucose levels. We hypothesise that the AID system can lead to a substantial improvement in glycaemic control for patients receiving haemodialysis (HD), peritoneal dialysis (PD) and patients with chronic kidney disease (CKD) stage 3b to 5 (not on dialysis).
The primary objective is to determine if the AID system is superior in regulating glucose levels, in people living with type 1 and type 2 diabetes, receiving HD, PD or having advanced CKD, compared with usual care. Secondary objectives are to evaluate the impact on life quality, incidence of hypoglycaemia and if this treatment is feasible for this population
This prospective, open-label, two-stage randomized-crossover study is conducted at the Department of Nephrology, Rigshospitalet Copenhagen and Steno Diabetes Center Copenhagen. The study is performed in collaboration with six Australian centres (St Vincent's Melbourne, Royal Melbourne, Austin, Cairns Base, Flinders, and Canberra Hospitals).
A total of 15 participants will be recruited in Copenhagen, with participants evenly distributed across the three disease categories (HD, PD, and advanced CKD). Data collected from Copenhagen will be pooled with data obtained from the Australian centers.
Participants entering the study will have a four-to-six-week run-in phase with diabetes education (carbohydrate counting, inserting of CGM etc). Training will consist of three sessions of 2-4 hours with a dedicated diabetes nurse. During the run-in phase three weeks of unblinded CGM will be performed to assess baseline glucose levels. All participants will be randomized 1:1 to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of control (usual care) with cross over at the end of the first eight weeks.
The trial will be conducted in compliance with the Good Clinical Practice (GCP) guidelines, and written informed consent will be obtained before any trial activities are performed. The project including a plan for the handling of personal information will be approved by the Danish Data Protection Agency before initiation. If necessary, the Danish Medicines Agency and the responsible GCP unit will be granted access to journals, documents, and other materials relevant to the project. All participants will be assigned with a subject number and will be recorded on data sheets. Only tubes will appear with subject number and trial ID. Information on full name and social security and subject numbers will be stored separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Design: Prospective, open-label, two-stage randomised-crossover study. Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5). Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels. All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks. CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: 2nd Generation Automated Insulin Delivery (AID) system2nd Generation Automated Insulin Delivery system (Medtronic MiniMed 780G) |
| Control Group | No intervention | –Usual care consisting of participants current insulin-treatment (either multiple daily injection with insulin or traditional insulin pump therapy with manual determination of insulin dosing) and real-time CGM if already used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained before any trial-related procedures are performed
- Type 1 diabetes of at least 1-year duration or insulin requiring type 2 diabetes (Total insulin dose should be below 200 IE per day)
- Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis).
- Subject must be willing and able to comply with trial protocol
- HbA1c <91 mmol/mol (10.5%)
Key exclusion criteria (10 listed)
- History of ketoacidosis within the past 6 months
- Moderate to severe cognitive impairment
- Major allergy to tape/ adhesives
- Women who are pregnant or planning pregnancy
- Life-expectancy to <6 months
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 |
|---|---|---|
| 2nd Generation Automated Insulin Delivery (AID) systemAlso: Medtronic MiniMed 780GThe AID system will initially commence delivery by insulin pump post-randomisation without the AID in operation and with predictive low glucose suspend activated for a period of two weeks. Once safety has been established, the autocorrect function can be activated and the setpoint reduced to 5.5 mmol/L. Throughout the study insulin pump uploads will be reviewed twice weekly initially and at least weekly thereafter. | Device | Intervention Group |
Primary outcome
Percent time in sensor glucose target range (3.9-10.0 mmol/L)
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Assessed by 3 continuous weeks of CGM
34 secondary outcomes
Proportion of time spent <2.8 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.0 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.3 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent <3.9 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent 3.9-7.8
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >10.0 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >13.9 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Proportion of time spent >16.7 mmol/L
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Glucose variability (SD and coefficient of variation)
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Mean glucose
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
HbA1c
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia
Time frame: Week 0-22
eGFR (estimated glomerular filtration rate)
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Potassium pre-dialysis
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Urine albumine-to-creatinine ratio
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Actigraph Metrics for sleep architecture
Time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
Sleep diary
Time frame: Week 6-22
Proportion of time Automode is active
Time frame: Weekly assessed: week 6-22
Diabetic ketoacidosis
Time frame: Week 0-22
Severe hypoglycemia
Time frame: Week 0-22
Serious Adverse Event
Time frame: Week 0-22
Unanticipated Serious Adverse Device Event
Time frame: Week 0-22
Satisfaction with diabetes treatment
Time frame: Enrollment visit: week 0; end of phase 1: week 14; end of phase 2: week 22
Satisfaction with diabetes treatment
Time frame: End of phase 1: week 14; end of phase 2: week 22
Fear of hypoglycaemia
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Hypoglycaemia awareness
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Diabetes distress
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Sleep Quality
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Cognitive function
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Sarcopenia
Time frame: End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Semi-structured interview
Time frame: End of phase 1: week 14; end of phase 2: week 22
Health-related quality of life
Time frame: Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Frailty
Time frame: End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 42108331Lu JC, Meyer-Olesen CL, Halim B, Vogrin S, Christensen MB, Apostolopoulos J, Bomholt T, MacIsaac RJ, Lee P, Trawley S, Cohen N, Fourlanos S, Stranks S, Jenkins AJ, Ekinci E, Hornum M, Norgaard K, O'Neal DN. The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease. Diabetologia. 2026 Aug;69(8):2168-2181. doi: 10.1007/s00125-026-06732-3. Epub 2026 May 11.
- Individual participant dataSharing planned: No
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Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Tobias Bomholt, MD, PhD principal investigator
Department of Nephrology, Rigshospitalet, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2nd Generation Automated Insulin Delivery (AID) system in people with Dialysis and Chronic Kidney Disease, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 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 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent time in sensor glucose target range (3.9-10.0 mmol/L) (time frame: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22). 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 NCT06330194, which also lists 1 linked publication.
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.