Clinical trial NCT02160275: Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format
Official title: Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Artificial pancreas
Bi-hormonal closed loop
Diabetes Type 1
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: European Commission
name: Rijnstate Hospital
First posted: 2014-06-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean sensor glucose concentration
timeFrame: Day 2-4
Secondary outcomes:
measure: Proportion of time spent in each glycemic category
timeFrame: Day 2-4
measure: Number of events in each glycemic category
timeFrame: Day 2-4
measure: Number of carbohydrate-treated hypoglycemic events
timeFrame: Day 2-4
measure: Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)
timeFrame: Day 2-4
measure: Glycemic variability
timeFrame: Day 2-4
measure: Mean sensor glucose concentration during specific periods
timeFrame: Day 2-4
measure: Mean absolute relative difference between sensor values and self-monitored blood glucose values
timeFrame: Day 2-4
measure: Heart rate
timeFrame: Day 2-4
measure: Physical activity
timeFrame: Day 2-4
measure: Mean glucose concentration per day
timeFrame: Day 1-4
measure: Time that the control algorithm is inactive
timeFrame: Day 1-4
Other outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Length
timeFrame: Baseline
measure: Insulin use
timeFrame: Day 1-4
measure: Glucagon use
timeFrame: Day 1-4
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam
name: J. Hans DeVries, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: