Day and Night Closed-loop in Young People With Type 1 Diabetes (DAN05)
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|ClinicalTrials.gov Identifier: NCT02925299|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : October 3, 2019
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.
This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group).
It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy.
Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases||Device: FlorenceM (US) and FlorenceX (UK) Device: Insulin pump therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-centre, Randomized, Single-period, Parallel Study to Assess the Efficacy, Safety and Utility of 6 Month Day-and-night Automated Closed-loop Insulin Delivery Under Free Living Conditions Compared to Insulin Pump Therapy in Children and Adolescents With Type 1 Diabetes|
|Actual Study Start Date :||May 12, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: 24/7 closed loop insulin delivery
The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed, and (3) an insulin pump that delivers the insulin. The name of this closed-loop system used in the US is FlorenceM (Medtronic 640G pump and Guardian3 sensor). The name of this closed-loop system in the UK is FlorenceX (DANA pump and Dexcom sensor). Half of the individuals taking part in the study will use the closed-loop study system for 6 months.
Device: FlorenceM (US) and FlorenceX (UK)
The automated closed loop system (FlorenceM in US) will consist of:
Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Guardian3 CGM and glucose suspend feature.
The automated closed loop system (FlorenceX in UK) will consist of:
The DANA Diabecare R insulin pump (Sooil Development, Korea) incorporating the Dexcom G6 CGM.
An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.
Active Comparator: Insulin pump therapy
Half of the Subjects will continue using their own insulin pump for 6 months.
Device: Insulin pump therapy
Subjects will continue using their own insulin pump for 6 months.
- The primary outcome is the centralised measurement of glycated haemoglobin (HbA1c) at 6 months. [ Time Frame: HbA1c will be taken at baseline, 3 and 6 months ]The objective is to assess efficacy of day and night automated closed-loop glucose control combined with low glucose feature in improving HbA1c, as compared with insulin pump therapy alone.
- Time spent in the target glucose range (3.9 to 10mmol/l) (70 to 180mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time spent below target glucose (3.9mmol/l)(70mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Mean and standard deviation or percentiles sensor glucose [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Coefficient of variation of glucose levels [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels < 3.5 mmol/l (63 mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels <3.0 mmol/l (54 mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Changes in total basal and bolus insulin dose [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on CRF and insulin pump data.
- AUC of glucose below 3.5mmol/l (63mg/dl) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- AUC glucose above 10.0mmol/L (180mg/dL) [ Time Frame: 6 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- HbA1c <7.0%, HbA1c <7.5%, Relative reduction ≥10% from baseline. o Absolute reduction ≥0.5% from baseline o Absolute reduction ≥1% from baseline o Absolute reduction ≥1% from baseline or HbA1c <7.0% [ Time Frame: 6 months ]Binary metrics for HbA1c
- Safety Evaluation [ Time Frame: 6 months ]Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association (adolescents), and International Society for Pediatric and Adolescent Diabetes (children), frequency of diabetic ketoacidosis (DKA), frequency of severe hyperglycaemia (>16.7 mmol/l)(>300mg/dl) with significant ketosis (plasma ketones >0.6mmol/l) and nature and severity of other adverse events
- Utility evaluation [ Time Frame: 6 months ]Assessment of the frequency and duration of use of the closed-loop system
- Human Factors Assessment [ Time Frame: 6 months ]Cognitive, emotional, and behavioural characteristics of participating subjects and family members and their response to the closed-loop system and clinical trial will be assessed gathering both quantitative (validated surveys) and qualitative data (focus groups)
- Health Economic Evaluation [ Time Frame: 6 months ]Cost utility analysis on the benefits of closed loop insulin delivery to inform reimbursement decision-making
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925299
|Contact: Roman Hovorka, PhD||+44 1223 762 firstname.lastname@example.org|
|Contact: Judy Sibayan, MPH, CCRPemail@example.com|
|United States, California|
|Stanford University||Active, not recruiting|
|Palo Alto, California, United States, 95032|
|United States, Colorado|
|University of Colorado Denver School of Medicine Barbara Davis Center||Active, not recruiting|
|Aurora, Colorado, United States, 80045|
|United States, Connecticut|
|Yale University||Active, not recruiting|
|Hartford, Connecticut, United States, 06520|
|United States, Florida|
|Nemours Children's Health System||Active, not recruiting|
|Jacksonville, Florida, United States, 32207|
|United States, Indiana|
|Indiana University||Active, not recruiting|
|Indianapolis, Indiana, United States, 43202|
|University of Cambridge||Recruiting|
|Cambridge, Cambridgeshire County, United Kingdom, CB2 0QQ|
|Contact: Charlotte Boughton, MD +44 1229 769066 firstname.lastname@example.org|
|Contact: Janet Allen, RN 44 1223 769064 email@example.com|
|Principal Investigator: Carlo Acerini, MD|
|Nottingham Children's Hospital||Recruiting|
|Nottingham, England, United Kingdom, NG5 1PB|
|Contact: Louise Denvir, MD 44 115 924 9924 ext 62336 Louise.firstname.lastname@example.org|
|Contact: Maria Saxton 0115 924 9924 ext 70680 Maria.Saxton@nuh.nhs.uk|
|Southampton Children's Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Nikki Davis, MD email@example.com|
|Contact: Helen Dewar 023 8120 4989 Helen.Dewar@uhs.nhs.net|
|The Leeds Teaching Hospitals NHS Trust||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|Contact: Fiona Campbell, MD 01132-064-996|
|Contact: Emily Metcalfe 0113 206 4996 ext 64996 firstname.lastname@example.org|
|Study Chair:||Roman Hovorka, PhD||University of Cambridge|
|Principal Investigator:||Carlo Acerini, MD||University of Cambridge|
|Principal Investigator:||Fiona Campbell, MD||The Leeds Teaching Hospitals NHS Trust|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|
|Principal Investigator:||Stuart Weinzimer, MD||Yale University|
|Principal Investigator:||Linda DiMeglio, MD||Indiana University|
|Principal Investigator:||Paul Wadwa, MD||University of Colorado Denver School of Medicine Barbara Davis Center|
|Principal Investigator:||Korey Hood, PhD||Stanford University|
|Principal Investigator:||Dana Goldman, PhD||University of Southern California|
|Principal Investigator:||Nikki C Davis, MD||Southampton Children's Hospital|
|Principal Investigator:||Louise Denvir, MD||Nottingham Children's Hospital|
|Principal Investigator:||Nelly Mauras, MD||Nemours Children's Health System|