Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, (APPEL5)

October 21, 2019 updated by: J.H. DeVries

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate Hospital
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Open loop
14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring
Device: Insulin pump therapy (with or without glucose sensor)
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)
Experimental: Closed loop
4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)
Device: Artificial pancreas (Inreda Diabetic)
Bi-hormonal reactive closed loop system without mealtime announcement
Other Names:
  • Closed loop therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time in target
Time Frame: Week 1-2
Proportion of time spent in the target range (3.9-10 mmol/l)
Week 1-2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time in hypoglycemia 1
Time Frame: Week 1-2 / Week 1 / Week 2
Proportion of time spent in hypoglycemia (<3.9 mmol/l)
Week 1-2 / Week 1 / Week 2
Time in hypoglycemia 2
Time Frame: Week 1-2 / Week 1 / Week 2
Proportion of time spent in hypoglycemia (<3.3 mmol/l)
Week 1-2 / Week 1 / Week 2
Time in hyperglycemia 1
Time Frame: Week 1-2 / Week 1 / Week 2
Proportion of time spent in hyperglycemia (>10 mmol/l)
Week 1-2 / Week 1 / Week 2
Time in hyperglycemia 2
Time Frame: Week 1-2 / Week 1 / Week 2
Proportion of time spent in hyperglycemia (>13.9 mmol/l)
Week 1-2 / Week 1 / Week 2
Hypoglycemic events
Time Frame: Week 1-2 / Week 1 / Week 2
Number of carbohydrate-treated hypoglycemic events
Week 1-2 / Week 1 / Week 2
Mean or median glucose
Time Frame: Week 1-2 / Week 1 / Week 2
Mean or median sensor glucose concentration
Week 1-2 / Week 1 / Week 2
Mean or median day glucose
Time Frame: Day time: Week 1-2 / Week 1 / Week 2
Mean or median sensor glucose concentration
Day time: Week 1-2 / Week 1 / Week 2
Mean or median night glucose
Time Frame: Night time: Week 1-2 / Week 1 / Week 2
Mean or median sensor glucose concentration
Night time: Week 1-2 / Week 1 / Week 2
Mean or median postprandial glucose
Time Frame: Postprandial: Week 1-2 / Week 1 / Week 2
Mean or median sensor glucose concentration
Postprandial: Week 1-2 / Week 1 / Week 2
Glycemic variability 1
Time Frame: Week 1-2 / Week 1 / Week 2
Interquartile range (IQR)
Week 1-2 / Week 1 / Week 2
Glycemic variability 2
Time Frame: Week 1-2 / Week 1 / Week 2
Coefficient of variation (CV)
Week 1-2 / Week 1 / Week 2
Glycemic variability 3
Time Frame: Week 1-2 / Week 1 / Week 2
Low blood glucose index (LBGI)
Week 1-2 / Week 1 / Week 2
Glycemic variability 4
Time Frame: Week 1-2 / Week 1 / Week 2
High blood glucose index (HBGI)
Week 1-2 / Week 1 / Week 2
Glycemic variability 5
Time Frame: Week 1-2 / Week 1 / Week 2
Blood glucose risk index (BGRI)
Week 1-2 / Week 1 / Week 2
Time in target
Time Frame: Week 1 / Week 2
Proportion of time spent in the target range (3.9-10 mmol/l)
Week 1 / Week 2
PAID: Problem Areas In Diabetes questionnaire
Time Frame: Baseline / End week 2
Total score; Scale 0 (no problems) to 80 (big problems)
Baseline / End week 2
EQ5D: EuroQol 5 Dimensions questionnaire
Time Frame: Baseline / End week 2
Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems")
Baseline / End week 2
DTSQ-status: Diabetes Treatment Satisfaction Questionnaire
Time Frame: Baseline / End week 2
Total score: Scale 0 (negative) to 36 (positive)
Baseline / End week 2
DTSQ-change: Diabetes Treatment Satisfaction Questionnaire
Time Frame: End week 2
Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive)
End week 2
Algorithm active time
Time Frame: Week 1-2 (closed loop only)
Percentage of time that the closed loop algorithm is active
Week 1-2 (closed loop only)
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)
End week 2 (closed loop only)
Glucose measurement performance
Time Frame: Day 3, 4 or 5 of the training period prior to the closed loop
MARD
Day 3, 4 or 5 of the training period prior to the closed loop

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline
Baseline
Length
Time Frame: Baseline
Baseline
Demographic variables
Time Frame: Baseline
Baseline
HbA1c plasma concentration
Time Frame: Baseline
Baseline
Meals
Time Frame: Week 1-2
Carbohydrate intake
Week 1-2
Physical activity 1
Time Frame: Week 1-2

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

)
Week 1-2
Physical activity 2
Time Frame: Week 1-2

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

)
Week 1-2
Physical activity 3
Time Frame: Week 1-2
Total number of exercise moments
Week 1-2
Physical activity 4
Time Frame: Week 1-2
Total duration of exercise moments
Week 1-2
Insulin dose
Time Frame: Week 1-2
Daily average
Week 1-2
Glucagon dose
Time Frame: Week 1-2
Daily average
Week 1-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
J.H. DeVries

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rijnstate Hospital
Inreda Diabetic B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J.H. DeVries, MD PhD, Academisch Medisch Centrum, Universiteit van Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL55693.018.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings