AzTrials
AzTrials

Diabetes Mellitus, Type 1APPEL4NCT02160275

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

A study testing Artificial Pancreas (Inreda Diabetic BV) and Insulin pump therapy 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
Search all trials

Trial 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. 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?
Artificial Pancreas (Inreda Diabetic BV) and Insulin pump therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesNetherlands
Study dates
Jun 2014to Jun 2015
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 insulin pump therapy for a minimum of 6 months
  • Age between 18 and 75 years
  • 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
  • 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

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 4

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.

Being tested
Artificial Pancreas (Inreda Diabetic BV), Insulin pump therapy
Keywords
Artificial pancreas, Bi-hormonal closed loop, Diabetes Type 1
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.

  • Artificial Pancreas (Inreda Diabetic BV)Device

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

  • Insulin pump therapyDevice

    Also called Continuous subcutaneous insulin infusion

    Patients' own insulin pump with fast-acting insulin analog

Study groups in NCT02160275
Study groupRoleWhat they receive
Open LoopActive comparator4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring
Receives: Device: Insulin pump therapy
Closed LoopExperimental4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
Receives: Device: Artificial Pancreas (Inreda Diabetic BV)

What is being measured

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

  1. Mean sensor glucose concentration

    Measured: Day 2-4

Secondary outcomes (11)

  1. Proportion of time spent in each glycemic category

    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)

    Measured: Day 2-4

  2. Number of events in each glycemic category

    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)

    Measured: Day 2-4

  3. Number of carbohydrate-treated hypoglycemic events

    Measured: Day 2-4

  4. Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)

    Measured: Day 2-4

  5. Glycemic variability

    Calculated as Interquartile Range (IQR)

    Measured: Day 2-4

  6. Mean sensor glucose concentration during specific periods

    Periods:

    • Day
    • Night
    • Postprandial

    Measured: Day 2-4

  7. Mean absolute relative difference between sensor values and self-monitored blood glucose values

    Measured: Day 2-4

  8. Heart rate

    Measured: Day 2-4

  9. Physical activity

    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).

    Measured: Day 2-4

  10. Mean glucose concentration per day

    Intervention arm (closed loop) only

    Measured: Day 1-4

  11. Time that the control algorithm is inactive

    Intervention arm (closed loop) only

    Measured: Day 1-4

Timeline

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

  1. First posted10 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160275
Sponsor's protocol ID
NL43469.018.13
Acronym
APPEL4
Status last verified
Oct 2015
First submitted
5 Jun 2014
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Pancreas (Inreda Diabetic BV) and Insulin pump therapy 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 4 inclusion and 8 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 2 Oct 2015. 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?

Mean sensor glucose concentration (time frame: Day 2-4). 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 NCT02160275.

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 2 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
APPEL4 Clinical Trial NCT02160275 | AzTrials