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Trial record 58 of 747 for:    Area Under Curve AND meal

Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02397265
Recruitment Status : Suspended (Awaiting further funding)
First Posted : March 24, 2015
Last Update Posted : March 22, 2016
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on a mathematical model of beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.

Development of closed-loop insulin delivery devices to intensify control without hypoglycaemia has been extensively reviewed and have shown encouraging results . However, they have not yet proven to be robust when challenged with uncertainty and the external challenges (such as mixed meal contents, physical exercise, physiological stress and intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to outside the clinical environment.

The principal research objective is to assess the safety and efficacy of a closed-loop system for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome from the studies will be % time spent with a glucose concentration in the target range (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or high glucose excursions and is the principal measure of efficacy for closed-loop insulin delivery systems in the scientific literature. Other measured outcomes will be % time spent in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High Blood Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve. All measures have been previously published and validated.

This clinical trial protocol assesses the artificial pancreas system in three separate sub-studies:

  1. In a bi-hormonal (insulin and glucagon) configuration
  2. During and after exercise with bi-hormonal closed loop, and standard insulin opened loop
  3. During and after meals of mixed composition with bi-hormonal closed loop, and standard insulin opened loop

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Bi-hormonal closed loop pump Device: Standard opened loop pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Bihormonal closed loop
Bi-hormonal closed loop pump will be used in the exercise and mixed meal substudies
Device: Bi-hormonal closed loop pump
Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump

Active Comparator: Standard opened loop pump
Standard opened loop pump will be used in the exercise and mixed meal substudies
Device: Standard opened loop pump
Using a standard opened loop pump

Primary Outcome Measures :
  1. Percentage time in target range defined as 3.9-10mmol/l. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage time spent in euglycaemia (3.9-7.8mmol/l) [ Time Frame: 1 year ]
  2. percentage time spent in hypoglycaemia (<3.9mmol/l) [ Time Frame: 1 year ]
  3. Percentage time spent in hyperglycaemia (>10mmol/l) [ Time Frame: 1 year ]
  4. Mean venous blood and sensor glucose [ Time Frame: 1 year ]
  5. Glycaemic variability [ Time Frame: 1 year ]
  6. Glycaemic risk as measured by LBGI and HBGI [ Time Frame: 1 year ]
  7. Closed loop error grid analysis [ Time Frame: 1 year ]
  8. Glucose area under the curve [ Time Frame: 1 year ]
  9. Insulin requirement in units/kg/hr [ Time Frame: 1 year ]
  10. Glucagon requirements [ Time Frame: 1 year ]

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

Inclusion Criteria:

  • Adults over 18 years of age
  • Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
  • Type 1 diabetes for greater than 1 year
  • Continuous subcutaneous insulin infusion for greater than 6 months
  • HbA1c < 10% (86mmol/mol)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia and hypoglycaemia unawareness
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Allergic to lactose
  • Allergic to glucagon

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 identifier (NCT number): NCT02397265

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United Kingdom
Imperial College
London, United Kingdom
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Nick Oliver, MRCP Imperial College London


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Responsible Party: Imperial College London Identifier: NCT02397265     History of Changes
Other Study ID Numbers: 14SM2107
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: February 2015
Keywords provided by Imperial College London:
Type 1 diabetes
Closed loop insulin pump
Artificial pancreas
Mixed meals
Bihormonal pump
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
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs