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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Artificial Pancreas (Inreda Diabetic BV)
Insulin pump therapy
Sponsored by
J.H. DeVries
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Artificial pancreas, Bi-hormonal closed loop, Diabetes Type 1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital
  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open Loop

Closed Loop

Arm Description

4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring

4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)

Outcomes

Primary Outcome Measures

Mean sensor glucose concentration

Secondary Outcome Measures

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)
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)
Number of carbohydrate-treated hypoglycemic events
Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)
Glycemic variability
Calculated as Interquartile Range (IQR)
Mean sensor glucose concentration during specific periods
Periods: Day Night Postprandial
Mean absolute relative difference between sensor values and self-monitored blood glucose values
Heart rate
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).
Mean glucose concentration per day
Intervention arm (closed loop) only
Time that the control algorithm is inactive
Intervention arm (closed loop) only

Full Information

First Posted
June 5, 2014
Last Updated
October 1, 2015
Sponsor
J.H. DeVries
Collaborators
European Commission, Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02160275
Brief Title
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format
Acronym
APPEL4
Official Title
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J.H. DeVries
Collaborators
European Commission, Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Artificial pancreas, Bi-hormonal closed loop, Diabetes Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Loop
Arm Type
Active Comparator
Arm Description
4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring
Arm Title
Closed Loop
Arm Type
Experimental
Arm Description
4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas (Inreda Diabetic BV)
Intervention Description
Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype
Intervention Type
Device
Intervention Name(s)
Insulin pump therapy
Other Intervention Name(s)
Continuous subcutaneous insulin infusion
Intervention Description
Patients' own insulin pump with fast-acting insulin analog
Primary Outcome Measure Information:
Title
Mean sensor glucose concentration
Time Frame
Day 2-4
Secondary Outcome Measure Information:
Title
Proportion of time spent in each glycemic category
Description
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)
Time Frame
Day 2-4
Title
Number of events in each glycemic category
Description
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)
Time Frame
Day 2-4
Title
Number of carbohydrate-treated hypoglycemic events
Time Frame
Day 2-4
Title
Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)
Time Frame
Day 2-4
Title
Glycemic variability
Description
Calculated as Interquartile Range (IQR)
Time Frame
Day 2-4
Title
Mean sensor glucose concentration during specific periods
Description
Periods: Day Night Postprandial
Time Frame
Day 2-4
Title
Mean absolute relative difference between sensor values and self-monitored blood glucose values
Time Frame
Day 2-4
Title
Heart rate
Time Frame
Day 2-4
Title
Physical activity
Description
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).
Time Frame
Day 2-4
Title
Mean glucose concentration per day
Description
Intervention arm (closed loop) only
Time Frame
Day 1-4
Title
Time that the control algorithm is inactive
Description
Intervention arm (closed loop) only
Time Frame
Day 1-4
Other Pre-specified Outcome Measures:
Title
Demographic characteristics
Time Frame
Baseline
Title
Weight
Time Frame
Baseline
Title
Length
Time Frame
Baseline
Title
Insulin use
Time Frame
Day 1-4
Title
Glucagon use
Time Frame
Day 1-4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Hans DeVries, MD PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

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

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