- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160275
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format (APPEL4)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Arnhem, Gelderland, Netherlands, 6815 AD
- Rijnstate Hospital
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
- Academic Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
Day 2-4
|
Number of events in each glycemic category
Time Frame: Day 2-4
|
Glycemic categories:
|
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 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
Sponsor
Investigators
- Principal Investigator: J. Hans DeVries, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL43469.018.13
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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