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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02040571




Registration number
NCT02040571
Ethics application status
Date submitted
15/01/2014
Date registered
20/01/2014
Date last updated
14/04/2016

Titles & IDs
Public title
The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes
Scientific title
The Impact of the Overnight Closed Loop System on Glycemia, Subsequent Day-time Metabolic Control, Insulin Delivery, Counter Regulatory Hormones, Sleep Quality, Cognition and Satisfaction With Treatment, Compared to Open Loop System (Sensor Augmented Pump Therapy) in Both the Clinical Trial Centre and in the Home Setting in Type 1 Diabetes
Secondary ID [1] 0 0
U1111-1151-3297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Closed Loop
Treatment: Devices - Open Loop

Experimental: Closed Loop -

Active comparator: Open Loop -


Treatment: Devices: Closed Loop
A total of 24 participants with T1 Diabetes with sensor augmented insulin pump therapy (SAPT) experience will be recruited from four tertiary hospitals and will enter an un-masked randomised-control crossover trial, with a run-in period followed by two phases (in-hospital and at-home) in each of two stages (Closed Loop and Open Loop in random order). Closed Loop will be the intervention for this study, and its performance will be assessed compared to Open Loop (control treatment).

Treatment: Devices: Open Loop
The performance of closed loop system will be compared to open loop system (Sensor Augmented Pump Therapy). Therefore, the Open Loop system will be the control treatment.

In stage 1 of study, participants are randomized to either closed loop (CL) or open loop (OL). In stage 2, all participants will be crossed to the opposite study arm.

Throughout the study, those who randomised to OL will receive exactly the same medical attention as the CL participants.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous glucose monitoring (CGM) time spent in target glycaemic range (4.0-8.0 mmol/L) overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study.
Timepoint [1] 0 0
Participants will be monitored overnight during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Primary outcome [2] 0 0
Continuous glucose monitoring (CGM) time spent in target glycaemic range (4.0-8.0 mmol/L) from 2000h-0800h in clinical trial centre (phase 1 of the study).
Timepoint [2] 0 0
Participants will be monitored in clinical trial centre (phase 1 of the study), an expected average of 12 hours.
Secondary outcome [1] 0 0
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Timepoint [1] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [2] 0 0
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Timepoint [2] 0 0
Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [3] 0 0
CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).
Timepoint [3] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [4] 0 0
CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).
Timepoint [4] 0 0
Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [5] 0 0
CGM measures of glycaemic variability (standard deviation and margin of error).
Timepoint [5] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [6] 0 0
CGM measures of glycaemic variability (standard deviation and margin of error).
Timepoint [6] 0 0
Participants will be monitored overnight (0000h - 0800h) the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [7] 0 0
Number of episodes of blood ketone-positive hyperglycaemia (blood glucose > 15 mmol/L indicated by glucose sensor and confirmed by meter glucose AND blood ketones greater than or equal to 0.6 mmol/L).
Timepoint [7] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [8] 0 0
Number of episodes of blood ketone-positive hyperglycaemia (blood glucose > 15 mmol/L indicated by glucose sensor and confirmed by meter glucose AND blood ketones greater than or equal to 0.6 mmol/L).
Timepoint [8] 0 0
Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [9] 0 0
Yellow Springs Instrument (YSI) glucose measurements in target range (4.0-8.0 mmol/L).
Timepoint [9] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [10] 0 0
YSI glucose measurements in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L).
Timepoint [10] 0 0
Participants will be monitored from 2000h-0800h phase 1 of the study, an expected average of12 hours.
Secondary outcome [11] 0 0
YSI glycaemic variability (standard deviation).
Timepoint [11] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [12] 0 0
CGM time in glucose target range (4.0-8.0 mmol/L).
Timepoint [12] 0 0
Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
Secondary outcome [13] 0 0
CGM time in glucose target range (4.0-8.0 mmol/L).
Timepoint [13] 0 0
Participants will be monitored in daytime (0800h - 0000h during the ambulatory phase (Phase 2) of the study, an expected average of 16 hours each day for 4 days (Day 2-5 of phase 2).
Secondary outcome [14] 0 0
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Timepoint [14] 0 0
Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
Secondary outcome [15] 0 0
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Timepoint [15] 0 0
Participants will be monitored in daytime (0800h - 0000h) during the ambulatory phase (Phase 2) of the study, an expected average of 16 hours each day for 4 days (Day 2-5 of phase 2)
Secondary outcome [16] 0 0
CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).
Timepoint [16] 0 0
Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
Secondary outcome [17] 0 0
CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).
Timepoint [17] 0 0
Participants will be monitored in daytime (0800h - 0000h) the ambulatory phase (Phase 2) of the study, an expected average of 16 hours each day for 4 days (Day 2-5 of phase 2)
Secondary outcome [18] 0 0
Number of episodes of blood ketone-positive hyperglycaemia (blood glucose > 15 mmol/L indicated by glucose sensor and confirmed by meter glucose AND blood ketones greater than or equal to 0.6 mmol/L).
Timepoint [18] 0 0
Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
Secondary outcome [19] 0 0
Number of episodes of blood ketone-positive hyperglycaemia (blood glucose > 15 mmol/L indicated by glucose sensor and confirmed by meter glucose AND blood ketones greater than or equal to 0.6 mmol/L).
Timepoint [19] 0 0
Participants will be monitored in daytime (0800h - 0000h) the ambulatory phase (Phase 2) of the study, an expected average of 16 hours each day for 4 days (Day 2-5 of phase 2)
Secondary outcome [20] 0 0
Total insulin delivered (based on pump data)
Timepoint [20] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [21] 0 0
Total insulin delivered (based on pump data).
Timepoint [21] 0 0
Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [22] 0 0
Rates and number of changes in the rate of insulin infusion (based on pump data).
Timepoint [22] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [23] 0 0
Rates and number of changes in the rate of insulin infusion (based on pump data).
Timepoint [23] 0 0
Participants will be monitored overnight (0000h-0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [24] 0 0
Closed loop exits (with root cause identified) based on the monitoring by the investigator in real time from a co-located station.
Timepoint [24] 0 0
Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Secondary outcome [25] 0 0
Closed loop exits (with root cause identified) based on the remote monitoring by the investigator.
Timepoint [25] 0 0
Participants will be monitored overnight (0000h-0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).
Secondary outcome [26] 0 0
Total basal and total bolus insulin delivered (based on pump data)
Timepoint [26] 0 0
Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
Secondary outcome [27] 0 0
Total basal and total bolus insulin delivered (based on pump data).
Timepoint [27] 0 0
Participants will be monitored in daytime (0800h - 0000h) the ambulatory phase (Phase 2) of the study, an expected average of 16 hours each day for 4 days (Day 2-5 of phase 2)
Secondary outcome [28] 0 0
Urinary cortisol and catecholamines on 12-hour urine collection.
Timepoint [28] 0 0
Urine sample will be collected between 2000h-0800h in phase 1 of the study.
Secondary outcome [29] 0 0
Urinary cortisol and catecholamines on 12-hour urine collection.
Timepoint [29] 0 0
Urine sample will be collected between 2000h-0800h on Day 1 and Day 2 of the ambulatory phase (phase 2) of the study.
Secondary outcome [30] 0 0
Area under the curve for overnight plasma cortisol, growth hormone, glucagon, adrenaline and noradrenaline (based on hourly blood sample collection).
Timepoint [30] 0 0
Blood sample will be collected every hour beween 2000h-0800h in phase 1 of the study.
Secondary outcome [31] 0 0
Plasma metanephrines (based on blood sample collection)
Timepoint [31] 0 0
At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
Secondary outcome [32] 0 0
Plasma Cortisol, growth hormone, glucagon, adrenaline , noradrenaline and metanephrines based on blood sample collection.
Timepoint [32] 0 0
At 0800 A.M on Day 1 and 0800 A.M on Day 5 of phase 2.
Secondary outcome [33] 0 0
Urinary cortisol and catecholamines on 12-hour urine collection.
Timepoint [33] 0 0
Urine sample will be collected between 0800h and 2000h on Day 2 of phase 1 of the study.
Secondary outcome [34] 0 0
Urinary cortisol and catecholamines on 12-hour urine collection.
Timepoint [34] 0 0
Urine sample will be collected during between 0800h and 2000h of Day 1 and Day 2 of the ambulatory phase (phase 2) of the study.
Secondary outcome [35] 0 0
Sleep quality includes: total sleep time, sleep onset latency, sleep-efficiency, and wakefulness after sleep onset (WASO), total and average activity counts based on Actigraph data.
Timepoint [35] 0 0
Actigraph data will be recorded constantly during Phase 1 of the study, an expected average of 24 hours.
Secondary outcome [36] 0 0
Sleep quality includes: total sleep time, sleep onset latency, sleep-efficiency, and wakefulness after sleep onset (WASO), total and average activity counts based on Actigraph data and the Pittsburgh Sleep Quality Index scores.
Timepoint [36] 0 0
Actigraph data will be recorded constantly during the ambulatory phase (phase 2) of the study, an expected average of 5 days. Pittsburg Sleep quality Index tool will be done on day 1 and day 5 of phase 2.
Secondary outcome [37] 0 0
Parameters of Inflammation and Oxidative Stress include: Cell Adhesion Molecules, Myeloperoxidase, Oxidised LDL, hs-CRP (based on blood sample collection) and Urinary isoprostanes.
Timepoint [37] 0 0
At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
Secondary outcome [38] 0 0
Parameters of Inflammation and Oxidative Stress include: Cell Adhesion Molecules, Myeloperoxidase, Oxidised LDL, hs-CRP (C reactive Protein) based on blood sample collection, and Urinary isoprostanes.
Timepoint [38] 0 0
At 0800 A.M on Day 1 and Day 5 of phase 2.
Secondary outcome [39] 0 0
Diabetes Treatment Satisfaction Questionnaire and Semi-Structured Interviews (Questionnaires will generate total scores for treatment satisfaction, fear of hypoglycaemia, diabetes-related distress and hypoglycemia impaired awareness).
Timepoint [39] 0 0
On Day 5 of Phase 2 of the study.
Secondary outcome [40] 0 0
Cognitive Assessment: CogState assessment battery outcome measures will be generated. Each battery test point will record participant response times and accuracy rates for all tasks performed.
Timepoint [40] 0 0
Twice daily (AM-test and PM-test sessions) on Day 1, Day 2, Day 3, Day 4, and Day 5 of phase 2 of the study.

Eligibility
Key inclusion criteria
* Adults aged greater than 14 years able to provide informed consent.
* T1 Diabetes for a minimum of 6 months (fasting C-peptide levels less than 50 pmol/L).
* HbA1c less than 8.5%.
* Experience with a continuous glucose sensor with established basal insulin infusion patterns, insulin to carbohydrate ratios, regular use of the insulin bolus calculator, can insert/ change sensor by themselves, can recharge transmitter, and has experience in reading real time continuous glucose monitoring (RT-CGM) data.
* Accurate carbohydrate counting.
* Experience in uploading pump information to web.
* Residing in Melbourne or Perth.
* Willing to comply with the study protocol requirements inclusive of those requirements related to participant safety.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Requiring greater than 150 units of insulin/day.
* Diabetic ketoacidosis (DKA) within the past 4 weeks.
* Hypoglycaemic unawareness (Gold score = 4) while on SAPT
* More than 2 severe hypoglycaemic episodes within the last 12 months
* Pregnant or planning pregnancy within study period.
* Renal impairment (eGFR less than 60ml/min).
* Current or recent (less than 4 weeks) inhaled or oral steroid therapy.
* Dermatological conditions (eg psoriasis) involving the region of glucose sensor/ insulin delivery cannula insertion.
* Subject has physical limitations (eg impaired vision) that would compromise operation of the closed loop system.
* Currently involved in another investigational study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Juvenile Diabetes Research Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Medtronic
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1 Diabetes.
Trial website
https://clinicaltrials.gov/study/NCT02040571
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Norman O'neal
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02040571