Achieving Normal Glucose In Hospital Settings (Angie01)

This study has been completed.
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Kavita Kumareswaran, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01359241
First received: May 19, 2011
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.


Condition Intervention
Dysglycaemia
Procedure: closed-loop insulin delivery
Drug: Usual diabetes treatment regimen

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, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Percent of plasma glucose values within target range 3.9-8.0 mmol/l [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of sensor glucose values within target range 3.9-8.0 mmol/l [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Percent of plasma and sensor glucose values below 3.9 mmol/l [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Percent of plasma and sensor glucose values above 8.0 mmol/l [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Mean plasma and sensor glucose [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Mean plasma insulin concentration [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Total basal insulin insulin delivery [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Low blood glucose index (LBGI) score [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • High blood glucose index (HBGI) score [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Hyperglycaemic index score [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Percent of plasma and sensor glucose values below 3.0 mmol/l [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]
  • Standard deviation of plasma glucose [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Frequency of hypoglycaemia [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]
  • Frequency of hyperglycaemia [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: closed-loop insulin delivery
Subcutaneous insulin delivery adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Procedure: closed-loop insulin delivery
Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Active Comparator: Usual diabetes treatment regimen
Usual non-insulin glucose-lowering medications
Drug: Usual diabetes treatment regimen
Usual non-insulin glucose lowering medications

Detailed Description:

Algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. Our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. For patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. Insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. Closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.

The study has an open-label, randomised, two-period crossover design. Participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). A continuous glucose sensor will be inserted on arrival for each visit. Participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. Stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.

  Eligibility

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

Inclusion Criteria:

  • Aged 18 years or older
  • Type 2 diabetes for at least 1 year as defined by WHO
  • Treatment with glucose-lowering medication(s) (including Exenatide) for at least 6 mths
  • HbA1c between 7.0% and 10.0% inclusive (measured within past 3 mths)

Exclusion Criteria:

  • Autoimmune type 1 diabetes
  • Type 2 diabetes treated with insulin
  • Type 2 diabetes treated with diet control alone
  • Known or suspected allergy against insulin
  • Proliferative retinopathy
  • Current or planned pregnancy or breast feeding
  • Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359241

Locations
United Kingdom
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, United Kingdom, CB20QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Roman Hovorka, PhD University of Cambridge
  More Information

No publications provided

Responsible Party: Kavita Kumareswaran, Clinical Research Fellow, University of Cambridge
ClinicalTrials.gov Identifier: NCT01359241     History of Changes
Other Study ID Numbers: A092232
Study First Received: May 19, 2011
Last Updated: November 9, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Cambridge:
dysglycemia
diabetes
closed loop insulin delivery

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014