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Trial record 51 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions

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ClinicalTrials.gov Identifier: NCT02727231
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

Brief Summary:

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy in adults with type 1 diabetes and HbA1C<7.5%.

This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week run-in period, followed by two 4 weeks study periods during which glucose levels will be controlled either by an automated day- and night closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be recruited through diabetes clinics and other established methods in participating centers.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Florence D2A or similar closed loop glucose control system Device: CSII with CGM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: day and night closed loop control
Subjects glucose levels are controlled by Florence D2A or similar closed loop insulin delivery system
Device: Florence D2A or similar closed loop glucose control system
Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone

Active Comparator: usual insulin pump therapy management
Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (FreeStyle Navigator CGM)
Device: CSII with CGM
Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)




Primary Outcome Measures :
  1. Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring [ Time Frame: 4 weeks ]
    Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.


Secondary Outcome Measures :
  1. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    Time spent above and below the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.

  2. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    Average,standard deviation and coefficient of variation of glucose levels during 4 weeks of home periods

  3. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    The time with glucose levels < 3.5 mmol/l and <2.8 mmol/l during 4 weeks of home periods

  4. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    The time with glucose levels in the significant hyperglycaemia,(glucose levels > 16.7 mmol/l during 4 weeks of home periods

  5. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    Low Blood Glucose Index

  6. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    The "Area Under the Curve" below 3.5 mmol/l during 4 weeks home periods

  7. Continuous subcutaneous glucose monitoring (CGM) based outcome [ Time Frame: 4 weeks ]
    Between 24 hour period variability: Coefficient of variation of CGM glucose between 24 hour periods (midnight to midnight)

  8. Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 24:00 and 06:00 [ Time Frame: 4 weeks ]
    Time spent with CGM glucose concentration in range 3.9-10.0mmol/L

  9. Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 06:00 to 24:00 [ Time Frame: 4 weeks ]
    Time spent with CGM glucose concentration in the target range (3.9-10.0mmol/L)

  10. Insulin dose [ Time Frame: 4 weeks ]
    Total, basal and bolus insulin dose during 4 weeks of home periods

  11. Adverse Events [ Time Frame: 5 months ]
    Safety evaluation will comprise the number of episodes of hypoglycaemia, significant ketonemia (> 3.0mmol/l)as well as nature and severity of any other adverse events

  12. Utility Evaluation [ Time Frame: 4 weeks ]
    Utility evaluation is the percentage of closed-loop operation time during use at home, and when CGM was available


Other Outcome Measures:
  1. Accuracy of CGM [ Time Frame: 4 weeks ]
    CGM accuracy during 4 weeks home period; Capillary glucose vs. CGM will be evaluated using standard measures of numerical and clinical accuracy including absolute relative deviation and error grid analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has type 1 diabetes as defined by WHO
  • The subject is 18 years of age or older
  • The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
  • The subject is treated with one of the rapid acting insulin analogues (Insulin Aspart, Insulin Lispro or Insulin Glulisine)
  • HbA1c <7.5% (58mmol/mmol) based on analysis from central laboratory or equivalent
  • The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 6 measurements per day
  • The subject is willing to wear closed-loop system at home and at work place
  • The subject is willing to follow study specific instructions
  • The subject is willing to upload pump and CGM data at regular intervals
  • Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.

Exclusion Criteria:

  • Non-type 1 diabetes mellitus
  • Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
  • Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
  • Known or suspected allergy against insulin
  • Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
  • Significantly reduced hypoglycaemia awareness as judged by the investigator
  • More than one episode of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions).
  • Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mM(72 mg/dl) Total daily insulin dose > 2 IU/kg/day
  • Subject is pregnant or breast feeding or planning pregnancy in near future (within next 3 months)
  • Severe visual impairment
  • Severe hearing impairment
  • Subjects using implanted internal pacemaker
  • Lack of reliable telephone facility for contact
  • Subject not proficient in English (UK) or German (Austria)
  • Subjects who are living alone
  • Additional exclusion criteria specific for Austria: Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Additional exclusion criteria specific for Austria:Positive alcohol breath test.

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): NCT02727231


Locations
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Austria
Medical University of Graz
Graz, Austria, A8036
United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
Medical University of Graz
Investigators
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Principal Investigator: Roman Hovorka University of Cambridge

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Roman Hovorka, Dr, University of Cambridge
ClinicalTrials.gov Identifier: NCT02727231     History of Changes
Other Study ID Numbers: AP@home04 phase2
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Dr Roman Hovorka, University of Cambridge:
closed loop glucose control
hypoglycemia
type 1 diabetes
HbA1C<7.5%

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs