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Home Testing of Day and Night Closed Loop With Pump Suspend Feature (APCam11)

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ClinicalTrials.gov Identifier: NCT02523131
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Jaeb Center for Health Research
Cambridge University Hospitals NHS Foundation Trust
University College London Hospitals
The Leeds Teaching Hospitals NHS Trust
Manchester University NHS Foundation Trust
International Diabetes Center at Park Nicollet
University of Colorado Denver School of Medicine Barbara Davis Center
University of Edinburgh
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

Brief Summary:

The main study objective is to determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone.

This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature (intervention group) or by sensor augmented insulin pump therapy (control group).

It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21 years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres. Subjects who drop out within the first four weeks of the intervention may be replaced. Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device.

Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend 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 the time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free living phase. Secondary outcomes are HbA1 at the end of treatment period, the 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases Device: FlorenceM Device: Medtronic insulin pump 640G Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre, Randomised, Single-period, Parallel Design Study to Assess the Efficacy, Safety, Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sensor Augmented Insulin Pump Therapy in Youth and Adults With Type 1 Diabetes With Sub-optimal Glucose Control Under Free Living Conditions
Study Start Date : May 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 24/7 closed loop insulin delivery
Unsupervised home use of day and night automated closed loop insulin delivery system (FlorenceM) combined with pump suspend feature over a 12-week period using 24/7 Medtronic insulin pump 640G and Android smartphone.
Device: FlorenceM

The automated closed loop system (FlorenceM) will consist of:

  • Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM and glucose suspend feature.
  • An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.

Active Comparator: Sensor augmented pump therapy
Insulin pump therapy combined with unmasked real-time continuous glucose monitoring system for 12 weeks using Medtronic insulin pump 640G. Pump suspend features will be turned off.
Device: Medtronic insulin pump 640G
Next generation sensor-augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM. Glucose suspend features will be turned off.




Primary Outcome Measures :
  1. Time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels [ Time Frame: 12 week intervention phase ]
    both arms


Secondary Outcome Measures :
  1. HbA1c at the end of treatment period [ Time Frame: HbA1c will be taken at the end of 12-week study intervention. ]
    Between group differences in HbA1c levels at the end of treatment period adjusted for pre-study period HbA1c level.

  2. Time spent below target glucose (3.9mmol/l)(70mg/dl) [ Time Frame: 12 week intervention phase ]
    both arms

  3. Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [ Time Frame: 12 week intervention phase ]
    both arms

  4. Average of glucose levels [ Time Frame: 12 week intervention phase ]
    both arms

  5. The time with glucose levels < 3.5 mmol/l (63mg/dl) and <2.8 mmol/l (50mg/dl) [ Time Frame: 12 week intervention phase ]
    both arms

  6. The time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) [ Time Frame: 12 week intervention phase ]
    both arms

  7. Total, basal and bolus insulin dose [ Time Frame: 12 week intervention phase ]
    both arms

  8. AUC of glucose below 3.5mmol/l (63mg/dl) [ Time Frame: 12 week intervention phase ]
    both arms

  9. Standard deviation of glucose levels [ Time Frame: 12 week intervention phase ]
    both arms

  10. Coefficient of variation of glucose levels [ Time Frame: 12 week intervention phase ]
    both arms

  11. Number of pump suspend events [ Time Frame: 12 week intervention phase ]
    closed-loop arm only

  12. Change of body weight from screening to end of study [ Time Frame: 12 week intervention phase ]
    both arms


Other Outcome Measures:
  1. Number of episodes of severe hypoglycaemia per subject and incidence rate per 100-person years [ Time Frame: 12 week intervention phase ]
    Comparison of safety outcomes between the two treatment groups only include those events occurring on or after randomization until the last visit date or the last event date (whichever is later).

  2. Number of subjects with severe hypoglycemia events [ Time Frame: 12 week intervention phase ]
    Comparison of safety outcomes between the two treatment groups only include those events occurring on or after randomization until the last visit date or the last event date (whichever is later).

  3. Number of subjects with severe hyperglycemia events as defined by fingerprick glucose >16.7 mmol/l (>300 mg/dl) and plasma ketones >0.6 mmol/l [ Time Frame: 12 week intervention phase ]
    Comparison of safety outcomes between the two treatment groups only include those events occurring on or after randomization until the last visit date or the last event date (whichever is later).

  4. Number of subjects with DKA events [ Time Frame: 12 week intervention phase ]
    Comparison of safety outcomes between the two treatment groups only include those events occurring on or after randomization until the last visit date or the last event date (whichever is later).

  5. Number of any other serious adverse event reported [ Time Frame: 12 week intervention phase ]
    Comparison of safety outcomes between the two treatment groups only include those events occurring on or after randomization until the last visit date or the last event date (whichever is later).

  6. Amount of CL system use [ Time Frame: 12 week intervention phase ]
    Utility evaluation. The amount of system use in the CL arm will be calculated over the period starting from the day after treatment initiation until the earlier of the 12 week visit date or Day 84 from randomization (whichever comes first).

  7. Amount of CGM use [ Time Frame: 12 week intervention phase ]
    Utility evaluation. The amount of CGM use in both arm will be calculated over the period starting from the day after treatment initiation until the earlier of the 12 week visit date or Day 84 from randomization (whichever comes first).



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is at least 6 years or older [with equal proportion of youth (6 to 21 years) and adults (22 years and older)]
  2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
  3. The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
  4. The subject is treated with one of the rapid acting insulin analogues (insulin Aspart, Lispro or Glulisine)
  5. The subject is willing to perform regular capillary blood glucose monitoring, with at least 4 blood glucose measurements taken every day
  6. Screening HbA1c ≥ 7.5% (58.5mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent [with equal proportion of subjects above and below HbA1c 8.5% (69mmol/mol)]
  7. The subject is literate in English
  8. The subject is willing to wear glucose sensor
  9. The subject is willing to wear closed loop system at home
  10. The subject is willing to follow study specific instructions
  11. The subject is willing to upload pump and CGM data at regular intervals
  12. The subject is willing to restrict alcohol consumption to ≤ 2 units per day throughout the study period
  13. Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.
  14. The subject lives with someone who is trained to administer intramuscular glucagon and is able to seek emergency assistance.
  15. The subject has access to WIFi at home.

Exclusion Criteria:

  1. Non-type 1 diabetes mellitus including those secondary to chronic disease
  2. Subject using real-time CGM on regular basis in preceding 3 months
  3. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
  4. Untreated coeliac disease or thyroid disease or subject is being treated for hypothyroidism at time of screening
  5. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc.
  6. Known or suspected allergy to insulin
  7. Subjects with clinically significant nephropathy (eGFR < 45ml/min) or on dialysis, neuropathy or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator
  8. Adults: one or more episodes of severe hypoglycaemia as defined by American Diabetes Association (33) in preceding 6 months; Youth: recurrent incidents of severe hypoglycaemia during the previous 6 months (Adults and adolescents: severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital; children: severe hypoglycaemia is defined as an event associated with a seizure or loss of consciousness);
  9. Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mmol/l (72 mg/dl)
  10. Regular use of acetaminophen
  11. Lack of reliable telephone facility for contact
  12. Total daily insulin dose ≥ 2 IU/kg/day
  13. Total daily insulin dose < 15 IU/day
  14. Pregnancy, planned pregnancy, or breast feeding
  15. Severe visual impairment
  16. Severe hearing impairment
  17. Significantly reduced hypoglycaemia awareness in subjects 18 year and older (screening Gold score > 4)
  18. Subjects using implanted internal pace-maker
  19. Patients with medically documented allergy towards the adhesive (glue) of plasters or Subject is unable to tolerate tape adhesive in the area of sensor placement
  20. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor)
  21. Subject is currently abusing illicit drugs
  22. Subject is currently abusing prescription drugs
  23. Subject is currently abusing alcohol
  24. Subject is using pramlintide (Symlin) at time of screening
  25. Subject has elective surgery planned that requires general anaesthesia during the course of the study
  26. Subject is a shift worker with working hours between 10pm and 8am
  27. Subject has a sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  28. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  29. Subject diagnosed with current eating disorder such as anorexia or bulimia
  30. Subject plans to use significant quantity of herbal preparations (use of over the counter herbal preparation for 30 consecutive days or longer period during the study) or significant quantity of vitamin supplements (four times the recommended daily allowance used for 30 consecutive days or longer period during the study) during the course of their participation in the study

Information from the National Library of Medicine

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): NCT02523131


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Minnesota
International Diabetes Center at Park Nicollet
Minneapolis, Minnesota, United States, 55416
International Diabetes Centre at Park Nicollet
Minneapolis, Minnesota, United States, 55416
United Kingdom
University of Cambridge
Cambridge, United Kingdom, CB2 0QQ
Wellcome Trust-MRC Institute of Metabolic Science
Cambridge, United Kingdom, CB2 0QQ
Royal Hospital for Sick Children
Edinburgh, United Kingdom, EH9 1LF
Leeds Teaching Hospitals
Leeds, United Kingdom, LS9 7TF
Manchester Diabetes Centre, Manchester Royal Infirmary
Manchester, United Kingdom
Sponsors and Collaborators
University of Cambridge
Juvenile Diabetes Research Foundation
Jaeb Center for Health Research
Cambridge University Hospitals NHS Foundation Trust
University College London Hospitals
The Leeds Teaching Hospitals NHS Trust
Manchester University NHS Foundation Trust
International Diabetes Center at Park Nicollet
University of Colorado Denver School of Medicine Barbara Davis Center
University of Edinburgh
Investigators
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Study Director: Roman Hovorka, PhD Department of Paedatrics, University of Cambridge, UK
Principal Investigator: David B Dunger, Prof Department of Paedatrics, University of Cambridge, UK
Principal Investigator: Fiona Campbell, MD St James's University Hospital, Leeds, UK
Principal Investigator: Amy Criego, Prof International Diabetes Center at Park Nicollet, Minneapolis, USA
Principal Investigator: Mark Evans, MD Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
Principal Investigator: Lalantha Leelarathna, PhD Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, UK
Principal Investigator: Richard Bergenstal, Prof International Diabetes Center at Park Nicollet, Minneapolis, USA
Principal Investigator: Viral Shah, MD Barbara Davis Center for Childhood Diabetes, Aurora, USA
Principal Investigator: Daniela Elleri, MD Endocrine/Diabetes Department, Royal Hospital for Sick Children, Edinburgh, UK
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Roman Hovorka, Director of Research, University of Cambridge
ClinicalTrials.gov Identifier: NCT02523131    
Other Study ID Numbers: APCam11
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Dr Roman Hovorka, University of Cambridge:
Type 1 diabetes
Closed-loop glucose control
Artificial Pancreas
Continuous subcutaneous insulin infusion
Continuous glucose monitoring
threshold suspend
predictive low glucose suspend
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs