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Completed

NCT Number: NCT02160275

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Pancreas (Inreda Diabetic BV)

Device

Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype

Insulin pump therapy

Device

Patients' own insulin pump with fast-acting insulin analog

Other names: Continuous subcutaneous insulin infusion

Primary outcomes

  1. Mean sensor glucose concentration

    Time frame: Day 2-4

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

J.H. DeVries

Other

Collaborators

  • European Commission
  • Rijnstate Hospital

Registry information

Official study title

Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4

Acronym: APPEL4

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2014
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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