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Completed

NCT Number: NCT03858062

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

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

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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 SAP or CSII for a minimum of 6 months;
  • 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;
  • Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
  • Limited ability to see, and to hear or feel alarm signals of the closed loop system;
  • Skin condition prohibiting needle insertion;
  • Pregnancy and/or breastfeeding;
  • Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
  • Expected poor connectivity with internet regarding 24/7 tele monitoring;
  • Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

Treatment and study plan

Insulin pump therapy (with or without glucose sensor)

Device

Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor

Other names: Continuous subcutaneous insulin infusion (CSII), Sensor augmented pump therapy (SAP)

Artificial pancreas (Inreda Diabetic)

Device

Bi-hormonal reactive closed loop system without mealtime announcement

Other names: Closed loop therapy

Primary outcomes

  1. Time in target

    Time frame: Week 1-2

    Proportion of time spent in the target range (3.9-10 mmol/l)

Secondary outcomes

  1. Time in hypoglycemia 1

    Time frame: Week 1-2 / Week 1 / Week 2

    Proportion of time spent in hypoglycemia (<3.9 mmol/l)

  2. Time in hypoglycemia 2

    Time frame: Week 1-2 / Week 1 / Week 2

    Proportion of time spent in hypoglycemia (<3.3 mmol/l)

  3. Time in hyperglycemia 1

    Time frame: Week 1-2 / Week 1 / Week 2

    Proportion of time spent in hyperglycemia (>10 mmol/l)

  4. Time in hyperglycemia 2

    Time frame: Week 1-2 / Week 1 / Week 2

    Proportion of time spent in hyperglycemia (>13.9 mmol/l)

  5. Hypoglycemic events

    Time frame: Week 1-2 / Week 1 / Week 2

    Number of carbohydrate-treated hypoglycemic events

  6. Mean or median glucose

    Time frame: Week 1-2 / Week 1 / Week 2

    Mean or median sensor glucose concentration

  7. Mean or median day glucose

    Time frame: Day time: Week 1-2 / Week 1 / Week 2

    Mean or median sensor glucose concentration

  8. Mean or median night glucose

    Time frame: Night time: Week 1-2 / Week 1 / Week 2

    Mean or median sensor glucose concentration

  9. Mean or median postprandial glucose

    Time frame: Postprandial: Week 1-2 / Week 1 / Week 2

    Mean or median sensor glucose concentration

  10. Glycemic variability 1

    Time frame: Week 1-2 / Week 1 / Week 2

    Interquartile range (IQR)

  11. Glycemic variability 2

    Time frame: Week 1-2 / Week 1 / Week 2

    Coefficient of variation (CV)

  12. Glycemic variability 3

    Time frame: Week 1-2 / Week 1 / Week 2

    Low blood glucose index (LBGI)

  13. Glycemic variability 4

    Time frame: Week 1-2 / Week 1 / Week 2

    High blood glucose index (HBGI)

  14. Glycemic variability 5

    Time frame: Week 1-2 / Week 1 / Week 2

    Blood glucose risk index (BGRI)

  15. Time in target

    Time frame: Week 1 / Week 2

    Proportion of time spent in the target range (3.9-10 mmol/l)

  16. PAID: Problem Areas In Diabetes questionnaire

    Time frame: Baseline / End week 2

    Total score; Scale 0 (no problems) to 80 (big problems)

  17. EQ5D: EuroQol 5 Dimensions questionnaire

    Time frame: Baseline / End week 2

    Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems")

  18. DTSQ-status: Diabetes Treatment Satisfaction Questionnaire

    Time frame: Baseline / End week 2

    Total score: Scale 0 (negative) to 36 (positive)

  19. DTSQ-change: Diabetes Treatment Satisfaction Questionnaire

    Time frame: End week 2

    Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive)

  20. Algorithm active time

    Time frame: Week 1-2 (closed loop only)

    Percentage of time that the closed loop algorithm is active

  21. Usability score

    Time frame: End week 2 (closed loop only)

    Questionnaire: Mobile Phone Usability Questionnaire (MPUQ); Total score: Scale 62 (low level of usability) to 310 (higher level of usability)

  22. Glucose measurement performance

    Time frame: Day 3, 4 or 5 of the training period prior to the closed loop

    MARD

Other outcomes

  1. Demographic variables

    Time frame: Baseline

  2. Weight

    Time frame: Baseline

  3. Length

    Time frame: Baseline

  4. HbA1c plasma concentration

    Time frame: Baseline

  5. Meals

    Time frame: Week 1-2

    Carbohydrate intake

  6. Physical activity 1

    Time frame: Week 1-2

    Number of exercise moments per intensity category ("light", "moderate", "heavy'"

    )

  7. Physical activity 2

    Time frame: Week 1-2

    Duration of exercise moments per intensity category ("light", "moderate", "heavy'"

    )

  8. Physical activity 3

    Time frame: Week 1-2

    Total number of exercise moments

  9. Physical activity 4

    Time frame: Week 1-2

    Total duration of exercise moments

  10. Insulin dose

    Time frame: Week 1-2

    Daily average

  11. Glucagon dose

    Time frame: Week 1-2

    Daily average

Sponsors and collaborators

Lead sponsor

J.H. DeVries

Other

Collaborators

  • Inreda Diabetic B.V.
  • Rijnstate Hospital

Registry information

Official study title

Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 5

Acronym: APPEL5

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
Oct 22, 2019

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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