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Diabetes Mellitus, Type 1APPEL5NCT03858062

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

A study testing Insulin pump therapy (with or without glucose sensor) and Artificial pancreas (Inreda Diabetic) in people with Diabetes Mellitus, Type 1, run by J.H. DeVries at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Insulin pump therapy (with or without glucose sensor) and Artificial pancreas (Inreda Diabetic)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesNetherlands
Study dates
10 Mar 2019to 12 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with diabetes mellitus type 1;
  • Treated with SAP or CSII for a minimum of 6 months;
  • Willing and able to sign informed consent.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Academic Medical Center

    Amsterdam, North Holland, 1105 AZ

  • Rijnstate Hospital

    Arnhem, Gelderland, 6815 AD

Other trials in Netherlands

About this study

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

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.

Being tested
Insulin pump therapy (with or without glucose sensor), Artificial pancreas (Inreda Diabetic)
Keywords
Artificial pancreas, Glucose control
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin pump therapy (with or without glucose sensor)Device

    Also called Continuous subcutaneous insulin infusion (CSII), Sensor augmented pump therapy (SAP)

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

  • Artificial pancreas (Inreda Diabetic)Device

    Also called Closed loop therapy

    Bi-hormonal reactive closed loop system without mealtime announcement

Study groups in NCT03858062
Study groupRoleWhat they receive
Open loopActive comparator14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring
Receives: Device: Insulin pump therapy (with or without glucose sensor)
Closed loopExperimental4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)
Receives: Device: Artificial pancreas (Inreda Diabetic)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in target

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

    Measured: Week 1-2

Secondary outcomes (22)

  1. Time in hypoglycemia 1

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

    Measured: Week 1-2 / Week 1 / Week 2

  2. Time in hypoglycemia 2

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

    Measured: Week 1-2 / Week 1 / Week 2

  3. Time in hyperglycemia 1

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

    Measured: Week 1-2 / Week 1 / Week 2

  4. Time in hyperglycemia 2

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

    Measured: Week 1-2 / Week 1 / Week 2

  5. Hypoglycemic events

    Number of carbohydrate-treated hypoglycemic events

    Measured: Week 1-2 / Week 1 / Week 2

  6. Mean or median glucose

    Mean or median sensor glucose concentration

    Measured: Week 1-2 / Week 1 / Week 2

  7. Mean or median day glucose

    Mean or median sensor glucose concentration

    Measured: Day time: Week 1-2 / Week 1 / Week 2

  8. Mean or median night glucose

    Mean or median sensor glucose concentration

    Measured: Night time: Week 1-2 / Week 1 / Week 2

  9. Mean or median postprandial glucose

    Mean or median sensor glucose concentration

    Measured: Postprandial: Week 1-2 / Week 1 / Week 2

  10. Glycemic variability 1

    Interquartile range (IQR)

    Measured: Week 1-2 / Week 1 / Week 2

  11. Glycemic variability 2

    Coefficient of variation (CV)

    Measured: Week 1-2 / Week 1 / Week 2

  12. Glycemic variability 3

    Low blood glucose index (LBGI)

    Measured: Week 1-2 / Week 1 / Week 2

  13. Glycemic variability 4

    High blood glucose index (HBGI)

    Measured: Week 1-2 / Week 1 / Week 2

  14. Glycemic variability 5

    Blood glucose risk index (BGRI)

    Measured: Week 1-2 / Week 1 / Week 2

  15. Time in target

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

    Measured: Week 1 / Week 2

  16. PAID: Problem Areas In Diabetes questionnaire

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

    Measured: Baseline / End week 2

  17. EQ5D: EuroQol 5 Dimensions questionnaire

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

    Measured: Baseline / End week 2

  18. DTSQ-status: Diabetes Treatment Satisfaction Questionnaire

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

    Measured: Baseline / End week 2

  19. DTSQ-change: Diabetes Treatment Satisfaction Questionnaire

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

    Measured: End week 2

  20. Algorithm active time

    Percentage of time that the closed loop algorithm is active

    Measured: Week 1-2 (closed loop only)

  21. Usability score

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

    Measured: End week 2 (closed loop only)

  22. Glucose measurement performance

    MARD

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start10 Mar 2019
  3. Primary completion12 Sep 2019
  4. Study completion12 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03858062
Sponsor's protocol ID
NL55693.018.15
Acronym
APPEL5
Status last verified
Oct 2019
First submitted
21 Feb 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Bon AC, Luijf YM, Koebrugge R, Koops R, Hoekstra JB, DeVries JH. Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours. Diabetes Technol Ther. 2014 Mar;16(3):131-6. doi: 10.1089/dia.2013.0166. Epub 2013 Nov 13.

    PubMed 24224750

  • Blauw H, van Bon AC, Koops R, DeVries JH; , on behalf of the PCDIAB consortium. Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home. Diabetes Obes Metab. 2016 Jul;18(7):671-7. doi: 10.1111/dom.12663. Epub 2016 Apr 25.

    PubMed 26996542

  • Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial. Diabetes Care. 2021 Mar;44(3):836-838. doi: 10.2337/dc20-2106. Epub 2021 Jan 4.

    PubMed 33397767

Questions about this trial

What is this clinical trial studying?

A study testing Insulin pump therapy (with or without glucose sensor) and Artificial pancreas (Inreda Diabetic) in people with Diabetes Mellitus, Type 1, run by J.H. DeVries at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in target (time frame: Week 1-2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03858062, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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