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Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format (APPEL4)

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ClinicalTrials.gov Identifier: NCT02160275
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : October 2, 2015
Sponsor:
Collaborators:
European Commission
Rijnstate Hospital
Information provided by (Responsible Party):
J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control.

The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Artificial Pancreas (Inreda Diabetic BV) Device: Insulin pump therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Open Loop
4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring
Device: Insulin pump therapy
Patients' own insulin pump with fast-acting insulin analog
Other Name: Continuous subcutaneous insulin infusion

Experimental: Closed Loop
4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
Device: Artificial Pancreas (Inreda Diabetic BV)
Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype




Primary Outcome Measures :
  1. Mean sensor glucose concentration [ Time Frame: Day 2-4 ]

Secondary Outcome Measures :
  1. Proportion of time spent in each glycemic category [ Time Frame: Day 2-4 ]

    Glycemic categories:

    • Low glucose (<3.9 mmol/l and ≥ 3.3 mmol/l)
    • Very low glucose (<3.3 mmol/l and ≥ 2.8 mmol/l)
    • Dangerously low glucose (<2.8 mmol/l)
    • High glucose (> 10 mmol/l and ≤ 13.9 mmol/l)
    • Very high glucose (> 13.9 mmol/l and ≤ 22.2 mmol/)
    • Dangerously high glucose (> 22.2 mmol/l)

  2. Number of events in each glycemic category [ Time Frame: Day 2-4 ]

    Glycemic categories:

    • Low glucose (<3.9 mmol/l and ≥ 3.3 mmol/l)
    • Very low glucose (<3.3 mmol/l and ≥ 2.8 mmol/l)
    • Dangerously low glucose (<2.8 mmol/l)
    • High glucose (> 10 mmol/l and ≤ 13.9 mmol/l)
    • Very high glucose (> 13.9 mmol/l and ≤ 22.2 mmol/)
    • Dangerously high glucose (> 22.2 mmol/l)

  3. Number of carbohydrate-treated hypoglycemic events [ Time Frame: Day 2-4 ]
  4. Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l) [ Time Frame: Day 2-4 ]
  5. Glycemic variability [ Time Frame: Day 2-4 ]
    Calculated as Interquartile Range (IQR)

  6. Mean sensor glucose concentration during specific periods [ Time Frame: Day 2-4 ]

    Periods:

    • Day
    • Night
    • Postprandial

  7. Mean absolute relative difference between sensor values and self-monitored blood glucose values [ Time Frame: Day 2-4 ]
  8. Heart rate [ Time Frame: Day 2-4 ]
  9. Physical activity [ Time Frame: Day 2-4 ]
    Acceleration measured with a tri-axial accelerometer. The physical activity parameter is calculated as the magnitude of the total acceleration vector (square root of the sum of the squared axes).

  10. Mean glucose concentration per day [ Time Frame: Day 1-4 ]
    Intervention arm (closed loop) only

  11. Time that the control algorithm is inactive [ Time Frame: Day 1-4 ]
    Intervention arm (closed loop) only


Other Outcome Measures:
  1. Demographic characteristics [ Time Frame: Baseline ]
  2. Weight [ Time Frame: Baseline ]
  3. Length [ Time Frame: Baseline ]
  4. Insulin use [ Time Frame: Day 1-4 ]
  5. Glucagon use [ Time Frame: Day 1-4 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with diabetes mellitus type 1
  • Treated with insulin pump therapy for a minimum of 6 months
  • Age between 18 and 75 years
  • Willing and able to sign informed consent

Exclusion Criteria:

  • Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire
  • BMI > 35 kg/m2
  • HbA1c > 97 mmol/mol (=11.0 %)
  • Use of heparin, coumarin derivatives or oral corticosteroids
  • Skin condition prohibiting needle insertion
  • Pregnancy and/or breastfeeding
  • Living alone during the closed loop period (the patient may ask someone to stay over temporarily)
  • Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

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): NCT02160275


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
J.H. DeVries
European Commission
Rijnstate Hospital
Investigators
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Principal Investigator: J. Hans DeVries, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam
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Responsible Party: J.H. DeVries, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02160275    
Other Study ID Numbers: NL43469.018.13
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by J.H. DeVries, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Artificial pancreas
Bi-hormonal closed loop
Diabetes Type 1
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
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents