Short Term Closed-loop Glucose Control in Adults With Type 1 Diabetes (AP@home02)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
Profil Institut für Stoffwechselforschung GmbH
Medical University of Graz
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01666028
First received: August 9, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The main objective of this study is to determine the feasibility, efficacy and safety of automated closed-loop glucose control in the home setting over a short term period. The data and experienced gained from this study will be utilised in planning future home studies.

This is an open-label, three centre, randomised, crossover design, involving two, 8 day (first day in the clinical research facility and seven days at home) study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 24 adults (aiming for 18 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. During the 24 hour in-patient stay subjects will be encouraged to mimic their usual day and will be allowed to walk inside hospital premises. Subjects will be advised to discontinue automated closed-loop insulin delivery and follow their usual insulin pump therapy for periods of strenuous exercise during the 7 day home study phase.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics, and for the stay at the clinical research facility, time spent in the target range, above and below the target range as measured by plasma glucose.


Condition Intervention Phase
Type 1 Diabetes
Device: FlorenceD or similar closed loop glucose control system
Device: CSII with real-time CGM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Three-centre, Randomised, Two-period Crossover Study to Assess the Safety, Efficacy and Utility of Automated Closed-loop Glucose Control in Comparison With Continuous Subcutaneous Insulin Infusion Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes - A Combined Clinical Research Facility and Home Study

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) adjusted for sensor error. [ Time Frame: 7 day home study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time spent above and below the target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM) [ Time Frame: 7 day home study period ] [ Designated as safety issue: No ]
  • Average and standard deviation glucose levels based on continuous subcutaneous glucose monitoring [ Time Frame: 7 day home study period ] [ Designated as safety issue: No ]
  • The time with glucose levels < 3.5 mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring [ Time Frame: 7 Day home study period ] [ Designated as safety issue: Yes ]
  • The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l) [ Time Frame: 7 day home study period ] [ Designated as safety issue: No ]
  • Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring [ Time Frame: 7 day Home study period ] [ Designated as safety issue: No ]
  • During 24 hour in-patient stay - Same glucose metrics as during 7 day home stay but calculated based on continuous subcutaneous glucose monitoring (CGM) and plasma glucose measurements. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Number of episodes of hypoglycaemia, severe hypoglycaemia as well as nature and severity of any other adverse events. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Duration of use of the closed-loop system at home. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed Loop Glucose control
Subject's glucose level is controlled by the automated closed loop glucose control system
Device: FlorenceD or similar closed loop glucose control system
Subject's glucose level will be controlled by the FlorenceD or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator® 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 portable computer.
Active Comparator: CSII with real-time CGM
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
Device: CSII with real-time CGM
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has type 1 diabetes as defined by WHO
  2. The subject is 18 years of age or older
  3. The subject will have been on an insulin pump for at least 3 months currently using insulin Aspart, with good knowledge of insulin self-adjustment including carbohydrate counting
  4. HbA1c ≤ 10 % based on analysis from local laboratory
  5. The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 6 measurements per day during the 7 day home phase of the study
  6. The subject is willing to wear closed-loop system at home and at work place
  7. The subject is willing to follow study specific instructions
  8. The subject is literate in English
  9. Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening. In addition in Germany, women of childbearing potential must use a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e. less than 1% per year) and must use two independent methods of contraception, e.g. diaphragm and spermicide-coated condom.

Exclusion Criteria:

  1. Non-type 1 diabetes mellitus
  2. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
  3. Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
  4. Known or suspected allergy against insulin
  5. Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
  6. Significantly reduced hypoglycaemia awareness as judged by the investigator
  7. Total daily insulin dose more than 2 IU/kg/day
  8. Subject is pregnant or breast feeding or planning pregnancy in near future (within next 3 months)
  9. Severe visual impairment
  10. Severe hearing impairment
  11. Subjects using implanted internal pacemaker
  12. Lack of reliable telephone facility for contact

Additional exclusion criteria specific for Austria and Germany

  1. Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  2. Positive alcohol breath test.

Additional exclusion criteria specific for Germany only

Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666028

Locations
Austria
Medical University of Graz
Graz, Austria, A- 8036
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Profil Institut für Stoffwechselforschung GmbH
Medical University of Graz
Investigators
Principal Investigator: Mark Evans, FRCP (UK) MD University of Cambridge
Principal Investigator: Sabine Arnolds, MD Profil Institut für Stoffwechselforschung GmbH
Principal Investigator: Thomas Pieber, MD Medical University of Graz
Study Director: Roman Hovorka, PhD University of Cambridge
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Roman Hovorka, Principal Research Associate, University of Cambridge
ClinicalTrials.gov Identifier: NCT01666028     History of Changes
Other Study ID Numbers: AP@home02
Study First Received: August 9, 2012
Last Updated: September 9, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Cambridge:
Type 1 Diabetes
Closed Loop glucose control
Artificial Pancreas
CSII
CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014