Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format (APPEL4)

October 1, 2015 updated by: J.H. DeVries

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

    • 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

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Intervention / Treatment
Active Comparator: Open Loop
4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring
Patients' own insulin pump with fast-acting insulin analog
Other Names:
  • Continuous subcutaneous insulin infusion
Experimental: Closed Loop
4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean sensor glucose concentration
Time Frame: Day 2-4
Day 2-4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 2-4
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)
Day 2-4
Number of carbohydrate-treated hypoglycemic events
Time Frame: Day 2-4
Day 2-4
Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)
Time Frame: Day 2-4
Day 2-4
Glycemic variability
Time Frame: Day 2-4
Calculated as Interquartile Range (IQR)
Day 2-4
Mean sensor glucose concentration during specific periods
Time Frame: Day 2-4

Periods:

  • Day
  • Night
  • Postprandial
Day 2-4
Mean absolute relative difference between sensor values and self-monitored blood glucose values
Time Frame: Day 2-4
Day 2-4
Heart rate
Time Frame: Day 2-4
Day 2-4
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).
Day 2-4
Mean glucose concentration per day
Time Frame: Day 1-4
Intervention arm (closed loop) only
Day 1-4
Time that the control algorithm is inactive
Time Frame: Day 1-4
Intervention arm (closed loop) only
Day 1-4

Other Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Baseline
Baseline
Demographic characteristics
Time Frame: Baseline
Baseline
Length
Time Frame: Baseline
Baseline
Insulin use
Time Frame: Day 1-4
Day 1-4
Glucagon use
Time Frame: Day 1-4
Day 1-4

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: J. Hans DeVries, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam

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

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 8, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

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.

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