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

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ClinicalTrials.gov Identifier: NCT02397265
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
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 Device: Insulin closed loop Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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
Actual Study Start Date : December 3, 2014
Actual Primary Completion Date : July 22, 2015
Actual Study Completion Date : July 22, 2015

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Insulin only
Insulin only closed loop
Device: Insulin closed loop
Using a closed loop




Primary Outcome Measures :
  1. Percentage of Time in Target Range Over 24 Hour [ Time Frame: 24 hours ]
    The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).



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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT02397265


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

Publications:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02397265     History of Changes
Other Study ID Numbers: 14SM2107
First Posted: March 24, 2015    Key Record Dates
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 1 diabetes
Hypoglycaemia
Closed loop insulin pump
Artificial pancreas
Exercise
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
Insulin
Insulin, Globin Zinc
Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists