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Clinical Assessment of a Closed-loop Insulin Delivery System

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ClinicalTrials.gov Identifier: NCT01534013
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : August 28, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
The purpose of the study is to assess the safety and efficacy of the Imperial College closed loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: The Imperial College Closed-Loop Insulin Delivery System Device: Open loop Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Closed-loop Insulin Delivery System
Study Start Date : August 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Closed-loop insulin delivery
The closed loop device (bio-inspired artificial pancreas device, subcutaneous glucose monitor and insulin pump) will be applied to participants with type 1 diabetes
Device: The Imperial College Closed-Loop Insulin Delivery System
The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.
Other Names:
  • Closed-loop insulin delivery system
  • Artificial pancreas
  • Bio-inspired artificial pancreas

Active Comparator: Open-loop (Control visit)
Subcutaneous glucose monitor and pump will be applied to participants with type 1 diabetes
Device: Open loop
glucose sensor and pump




Primary Outcome Measures :
  1. Percentage Time in Euglycaemia [ Time Frame: 18 months ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.


Secondary Outcome Measures :
  1. % Time in Hypoglycaemia [ Time Frame: 18 months ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in hypoglycaemia is to be calculated using these blood glucose values.

  2. % Time Spent in Hyperglycaemia [ Time Frame: 18 months ]
    Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during patient visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.

  3. Glycaemic Variability as Measured by MAGE and SD [ Time Frame: 18 months ]
    Glycaemic variability as measured by MAGE and SD Calculation using CGM data

  4. Glycaemic Risk as Measured by LBGI and HBG [ Time Frame: 18 months ]
    Glycaemic risk as measured by LBGI and HBG Calculation using CGM data

  5. Closed Loop Error Grid Analysis [ Time Frame: 18 months ]
    Closed loop error grid analysis Calculation using CGM data

  6. Glucose Area Under the Curve [ Time Frame: 18 months ]
    Glucose area under the curve Calculation using CGM data

  7. Insulin Requirement in Units/kg/hr [ Time Frame: 18 months ]
    Calculation using average insulin delivered per hour and bodyweight



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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 <200nmol/L
  • Type 1 diabetes for greater than 1 year
  • Continuous subcutaneous insulin infusion for greater than 6 months
  • HbA1c < 8.5% (69mmol/mol)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy

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): NCT01534013


Locations
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United Kingdom
Imperial College London, St Mary's Campus
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Desmond Johnston, MBChB,PhD,FRCP Imperial College London
Publications:
Georgiou P, Toumazou C. Towards an ultra low power chemically inspired electronic beta cell for diabetes. Circuits and Systems, 2006. ISCAS 2006. Proceedings. 2006 IEEE International Symposium on, p. 173, 2006.
Ho M, Georgiou P, Singhal S, Oliver NS, Toumazou C. A bio-inspired closed loop insulin delivery based on the silicon pancreatic beta-cell. Circuits and Systems, 2008. ISCAS 2008. IEEE International Symposium on, pp. 1052-1055, 2008
Nathan D, Cleary P, Backlund J, Genuth S, Lachin J, Orchard T, Raskin R, Zinman B. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes,

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01534013    
Other Study ID Numbers: 13SM0363
First Posted: February 16, 2012    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: October 30, 2020
Last Verified: October 2020
Keywords provided by Imperial College London:
Closed loop insulin delivery
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
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents