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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FlorenceD or similar closed loop glucose control system
CSII with real-time CGM
Sponsored by
University of Cambridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Closed Loop glucose control, Artificial Pancreas, CSII, CGM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Medical University of Graz
  • Profil Institut für Stoffwechselforschung GmbH
  • Cambridge University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closed Loop Glucose control

CSII with real-time CGM

Arm Description

Subject's glucose level is controlled by the automated closed loop glucose control system

Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)

Outcomes

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.

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)
Average and standard deviation glucose levels based on continuous subcutaneous glucose monitoring
The time with glucose levels < 3.5 mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring
The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l)
Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring
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.
Number of episodes of hypoglycaemia, severe hypoglycaemia as well as nature and severity of any other adverse events.

Full Information

First Posted
August 9, 2012
Last Updated
December 1, 2014
Sponsor
University of Cambridge
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Profil Institut für Stoffwechselforschung GmbH, Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01666028
Brief Title
Short Term Closed-loop Glucose Control in Adults With Type 1 Diabetes
Acronym
AP@home02
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cambridge
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Profil Institut für Stoffwechselforschung GmbH, Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Closed Loop glucose control, Artificial Pancreas, CSII, CGM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop Glucose control
Arm Type
Experimental
Arm Description
Subject's glucose level is controlled by the automated closed loop glucose control system
Arm Title
CSII with real-time CGM
Arm Type
Active Comparator
Arm Description
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
Intervention Type
Device
Intervention Name(s)
FlorenceD or similar closed loop glucose control system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CSII with real-time CGM
Intervention Description
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Average and standard deviation glucose levels based on continuous subcutaneous glucose monitoring
Time Frame
7 day home study period
Title
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
Title
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
Title
Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring
Time Frame
7 day Home study period
Title
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
Title
Number of episodes of hypoglycaemia, severe hypoglycaemia as well as nature and severity of any other adverse events.
Time Frame
8 days
Other Pre-specified Outcome Measures:
Title
Duration of use of the closed-loop system at home.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 3 months currently using insulin Aspart, with good knowledge of insulin self-adjustment including carbohydrate counting HbA1c ≤ 10 % based on analysis from local laboratory 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 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 literate in English 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: 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 Total daily insulin dose more than 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 Additional exclusion criteria specific for Austria and Germany Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Evans, FRCP (UK) MD
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabine Arnolds, MD
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Pieber, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roman Hovorka, PhD
Organizational Affiliation
University of Cambridge
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
A- 8036
Country
Austria
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
D-41460
Country
Germany
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20138357
Citation
Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.
Results Reference
background
PubMed Identifier
21493665
Citation
Hovorka R, Kumareswaran K, Harris J, Allen JM, Elleri D, Xing D, Kollman C, Nodale M, Murphy HR, Dunger DB, Amiel SA, Heller SR, Wilinska ME, Evans ML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.
Results Reference
background
PubMed Identifier
26241693
Citation
Thabit H, Leelarathna L, Wilinska ME, Elleri D, Allen JM, Lubina-Solomon A, Walkinshaw E, Stadler M, Choudhary P, Mader JK, Dellweg S, Benesch C, Pieber TR, Arnolds S, Heller SR, Amiel SA, Dunger D, Evans ML, Hovorka R. Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions. Diabetes Technol Ther. 2015 Nov;17(11):801-7. doi: 10.1089/dia.2015.0062. Epub 2015 Aug 4.
Results Reference
derived
PubMed Identifier
24963110
Citation
Leelarathna L, Dellweg S, Mader JK, Allen JM, Benesch C, Doll W, Ellmerer M, Hartnell S, Heinemann L, Kojzar H, Michalewski L, Nodale M, Thabit H, Wilinska ME, Pieber TR, Arnolds S, Evans ML, Hovorka R; AP@home Consortium. Day and night home closed-loop insulin delivery in adults with type 1 diabetes: three-center randomized crossover study. Diabetes Care. 2014 Jul;37(7):1931-7. doi: 10.2337/dc13-2911.
Results Reference
derived

Learn more about this trial

Short Term Closed-loop Glucose Control in Adults With Type 1 Diabetes

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