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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Tobias Bomholt
Copenhagen, Denmark
Percent time in sensor glucose target range (3.9-10.0 mmol/L)
Assessed by 3 continuous weeks of CGM
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 <2.8 mmol/L
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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)
Assessed by 3 continuous weeks of CGM
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
Assessed by 3 continuous weeks of CGM
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
Blood sample
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
Assessed by 3 continuous weeks of CGM
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
Hospital presentations with either of the above
Time frame: 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
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
Blood sample. Only measured in patients from the HD-group
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
Urine sample. Only measured in patients from the CKD-group
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
Used concurrently with the CGM
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
Registered through uploads from insulin pump in the intervention arm
Time frame: Weekly assessed: week 6-22
Diabetic ketoacidosis
Time frame: Week 0-22
Severe hypoglycemia
Requiring third party assistance
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
Questionnaire: The Diabetes Treatment Satisfaction Questionnaire status \[DTSQs\]
Time frame: 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 \[DTSQc\]
Time frame: End of phase 1: week 14; end of phase 2: week 22
Fear of hypoglycaemia
Questionnaire: Hypoglycaemia Fear Survey \[HFS-II\]
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
Questionnaire: Gold Score and Clarke Score
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
Questionnaire: Problem Areas in Diabetes \[PAID\]
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
Questionnaire: Pittsburgh Sleep Quality Index \[PSQI\]
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
Questionnaire: Montreal Cognitive Assessment (MOCA)
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
SARC-F questionnaire
Time frame: 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.
Time frame: End of phase 1: week 14; end of phase 2: week 22
Health-related quality of life
Questionnaire: EQ-5D
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
Questionnaire: Fried Frailty
Time frame: End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22
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