Type 1 DiabetesNCT02040571
The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes
A study testing Closed Loop and Open Loop in people with Type 1 Diabetes, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed Loop and Open Loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2014to Dec 2015
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
At present, decisions regarding insulin dosing are made by the patient with intermittent support from their medical team. Even with glucose sensor augmented insulin pump therapy (SAPT), representing the most advanced technology currently available, there are emotional and intellectual demands placed upon the patient with the most well-educated, intelligent and diligent patients often unable to perfectly match insulin delivery with their varying requirements. SAPT does improve glycaemia in comparison with insulin pump therapy alone though a significant proportion of patients will still not meet target HbA1c (<7.0%). A Closed Loop (CL) system whereby a computerised algorithm reviews continuous glucose information to determine a T1D patient's insulin requirements and controls insulin delivery will potentially have a major impact upon acute and chronic complications of diabetes as well as upon their quality of life. Overnight glycaemic control, without the added challenge of meals, physical activity and stress, is a realistic initial application of CL in clinical practice.
This study aims to evaluate insulin pump therapy with an overnight CL system in comparison with current best available technology represented by SAPT in Type 1 Diabetes (T1D) patients, in both hospital and then at home. Outcomes of interest will include metabolic control and performance of the Medtronic CL overnight system compared with SAPT (OL), in both the Clinical Trials Centre (CTC) and in the home setting; the relationship between night-time and day-time metabolic control with CL and OL and nocturnal clinical, hormonal and inflammatory factors that may influence subsequent daytime metabolic control; anti-insulin antibody titres and dissociation constants (Rd) upon CL algorithm performance; sleep quality, cognition, satisfaction with treatment and psychological parameters.
A two phase randomised crossover study design is to be employed with the first phase conducted for a single night in the clinical trials centre and the second phase over 5 days in an ambulatory setting.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed Loop, Open Loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed LoopDevice
Also called Closed Loop Glucose-Sensing Insulin-Delivery System
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).
Open LoopDevice
Also called Sensor Augmented Pump Therapy (SAPT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop | Experimental | Not described Receives: Device: Closed Loop |
| Open Loop | Active comparator | Not described Receives: Device: Open Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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).
Measured: Participants will be monitored in clinical trial centre (phase 1 of the study), an expected average of 12 hours.
Secondary outcomes (40)
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Measured: 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).
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).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
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).
Measured: 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).
CGM measures of glycaemic variability (standard deviation and margin of error).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM measures of glycaemic variability (standard deviation and margin of error).
Measured: 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).
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).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
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).
Measured: 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).
Yellow Springs Instrument (YSI) glucose measurements in target range (4.0-8.0 mmol/L).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
YSI glucose measurements in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L).
Measured: Participants will be monitored from 2000h-0800h phase 1 of the study, an expected average of12 hours.
YSI glycaemic variability (standard deviation).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM time in glucose target range (4.0-8.0 mmol/L).
Measured: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
CGM time in glucose target range (4.0-8.0 mmol/L).
Measured: 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).
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Measured: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Measured: 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)
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).
Measured: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
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).
Measured: 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)
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).
Measured: Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
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).
Measured: 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)
Total insulin delivered (based on pump data)
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Total insulin delivered (based on pump data).
Measured: 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).
Rates and number of changes in the rate of insulin infusion (based on pump data).
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Rates and number of changes in the rate of insulin infusion (based on pump data).
Measured: 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).
Closed loop exits (with root cause identified) based on the monitoring by the investigator in real time from a co-located station.
Measured: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Closed loop exits (with root cause identified) based on the remote monitoring by the investigator.
Measured: 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).
Total basal and total bolus insulin delivered (based on pump data)
Measured: Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
Total basal and total bolus insulin delivered (based on pump data).
Measured: 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)
Urinary cortisol and catecholamines on 12-hour urine collection.
Measured: Urine sample will be collected between 2000h-0800h in phase 1 of the study.
Urinary cortisol and catecholamines on 12-hour urine collection.
Measured: Urine sample will be collected between 2000h-0800h on Day 1 and Day 2 of the ambulatory phase (phase 2) of the study.
Area under the curve for overnight plasma cortisol, growth hormone, glucagon, adrenaline and noradrenaline (based on hourly blood sample collection).
Measured: Blood sample will be collected every hour beween 2000h-0800h in phase 1 of the study.
Plasma metanephrines (based on blood sample collection)
Measured: At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
Plasma Cortisol, growth hormone, glucagon, adrenaline , noradrenaline and metanephrines based on blood sample collection.
Measured: At 0800 A.M on Day 1 and 0800 A.M on Day 5 of phase 2.
Urinary cortisol and catecholamines on 12-hour urine collection.
Measured: Urine sample will be collected between 0800h and 2000h on Day 2 of phase 1 of the study.
Urinary cortisol and catecholamines on 12-hour urine collection.
Measured: 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.
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.
Measured: Actigraph data will be recorded constantly during Phase 1 of the study, an expected average of 24 hours.
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.
Measured: 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.
Parameters of Inflammation and Oxidative Stress include: Cell Adhesion Molecules, Myeloperoxidase, Oxidised LDL, hs-CRP (based on blood sample collection) and Urinary isoprostanes.
Measured: At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
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.
Measured: At 0800 A.M on Day 1 and Day 5 of phase 2.
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).
Measured: On Day 5 of Phase 2 of the study.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Medtronic
- Responsible party
- Principal investigator, Amin Sharifi, St Vincent's Hospital Melbourne
- Investigators
- David Norman O'neal, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040571
- Sponsor's protocol ID
- U1111-1151-3297
- Status last verified
- Apr 2016
- First submitted
- 15 Jan 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02040571
- Acronym / sponsor ID
- U1111-1151-3297
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Medtronic
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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 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.
Detailed description
At present, decisions regarding insulin dosing are made by the patient with intermittent support from their medical team. Even with glucose sensor augmented insulin pump therapy (SAPT), representing the most advanced technology currently available, there are emotional and intellectual demands placed upon the patient with the most well-educated, intelligent and diligent patients often unable to perfectly match insulin delivery with their varying requirements. SAPT does improve glycaemia in comparison with insulin pump therapy alone though a significant proportion of patients will still not meet target HbA1c (<7.0%). A Closed Loop (CL) system whereby a computerised algorithm reviews continuous glucose information to determine a T1D patient's insulin requirements and controls insulin delivery will potentially have a major impact upon acute and chronic complications of diabetes as well as upon their quality of life. Overnight glycaemic control, without the added challenge of meals, physical activity and stress, is a realistic initial application of CL in clinical practice.
This study aims to evaluate insulin pump therapy with an overnight CL system in comparison with current best available technology represented by SAPT in Type 1 Diabetes (T1D) patients, in both hospital and then at home. Outcomes of interest will include metabolic control and performance of the Medtronic CL overnight system compared with SAPT (OL), in both the Clinical Trials Centre (CTC) and in the home setting; the relationship between night-time and day-time metabolic control with CL and OL and nocturnal clinical, hormonal and inflammatory factors that may influence subsequent daytime metabolic control; anti-insulin antibody titres and dissociation constants (Rd) upon CL algorithm performance; sleep quality, cognition, satisfaction with treatment and psychological parameters.
A two phase randomised crossover study design is to be employed with the first phase conducted for a single night in the clinical trials centre and the second phase over 5 days in an ambulatory setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Loop | Experimental | Device: Closed Loop |
| Open Loop | Active comparator | Device: Open Loop |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Closed LoopAlso: Closed Loop Glucose-Sensing Insulin-Delivery SystemA 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). | Device | Closed Loop |
| Open LoopAlso: Sensor Augmented Pump Therapy (SAPT)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. | Device | Open Loop |
Primary outcome
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.
Time frame: 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).
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).
Time frame: Participants will be monitored in clinical trial centre (phase 1 of the study), an expected average of 12 hours.
40 secondary outcomes
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Time frame: 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).
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).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
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).
Time frame: 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).
CGM measures of glycaemic variability (standard deviation and margin of error).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM measures of glycaemic variability (standard deviation and margin of error).
Time frame: 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).
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).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
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).
Time frame: 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).
Yellow Springs Instrument (YSI) glucose measurements in target range (4.0-8.0 mmol/L).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
YSI glucose measurements in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L).
Time frame: Participants will be monitored from 2000h-0800h phase 1 of the study, an expected average of12 hours.
YSI glycaemic variability (standard deviation).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
CGM time in glucose target range (4.0-8.0 mmol/L).
Time frame: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
CGM time in glucose target range (4.0-8.0 mmol/L).
Time frame: 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).
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Time frame: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).
Time frame: 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)
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).
Time frame: Participants will be monitored in daytime (0800h - 0000h) during the phase 1 of the study, an expected average of 16 hours.
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).
Time frame: 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)
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).
Time frame: Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
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).
Time frame: 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)
Total insulin delivered (based on pump data)
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Total insulin delivered (based on pump data).
Time frame: 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).
Rates and number of changes in the rate of insulin infusion (based on pump data).
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Rates and number of changes in the rate of insulin infusion (based on pump data).
Time frame: 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).
Closed loop exits (with root cause identified) based on the monitoring by the investigator in real time from a co-located station.
Time frame: Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.
Closed loop exits (with root cause identified) based on the remote monitoring by the investigator.
Time frame: 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).
Total basal and total bolus insulin delivered (based on pump data)
Time frame: Participants will be monitored in daytime (0800h - 0000h) the phase 1 of the study, an expected average of 16 hours.
Total basal and total bolus insulin delivered (based on pump data).
Time frame: 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)
Urinary cortisol and catecholamines on 12-hour urine collection.
Time frame: Urine sample will be collected between 2000h-0800h in phase 1 of the study.
Urinary cortisol and catecholamines on 12-hour urine collection.
Time frame: Urine sample will be collected between 2000h-0800h on Day 1 and Day 2 of the ambulatory phase (phase 2) of the study.
Area under the curve for overnight plasma cortisol, growth hormone, glucagon, adrenaline and noradrenaline (based on hourly blood sample collection).
Time frame: Blood sample will be collected every hour beween 2000h-0800h in phase 1 of the study.
Plasma metanephrines (based on blood sample collection)
Time frame: At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
Plasma Cortisol, growth hormone, glucagon, adrenaline , noradrenaline and metanephrines based on blood sample collection.
Time frame: At 0800 A.M on Day 1 and 0800 A.M on Day 5 of phase 2.
Urinary cortisol and catecholamines on 12-hour urine collection.
Time frame: Urine sample will be collected between 0800h and 2000h on Day 2 of phase 1 of the study.
Urinary cortisol and catecholamines on 12-hour urine collection.
Time frame: 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.
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.
Time frame: Actigraph data will be recorded constantly during Phase 1 of the study, an expected average of 24 hours.
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.
Time frame: 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.
Parameters of Inflammation and Oxidative Stress include: Cell Adhesion Molecules, Myeloperoxidase, Oxidised LDL, hs-CRP (based on blood sample collection) and Urinary isoprostanes.
Time frame: At 2000 P.M on Day 1 and 0800 A.M on Day 2 of phase 1 of the study.
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.
Time frame: At 0800 A.M on Day 1 and Day 5 of phase 2.
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).
Time frame: On Day 5 of Phase 2 of the study.
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.
Time frame: 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.
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 14 Apr 2016.
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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. This study is not recruiting at the moment.
David Norman O'neal principal investigator
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop and Open Loop in people with Type 1 Diabetes, run by St Vincent's Hospital Melbourne at 1 site in Australia.
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 8 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 14 Apr 2016. 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 Australia. 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?
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. (time frame: 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).). The study lists 2 primary outcomes in all. 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 14 Apr 2016.