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

Diabetes Mellitus, Type 1 Clinical Trial

— APPEL4  

Official title:

Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160275
• Other study ID #: NL43469.018.13
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: October 1, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Artificial Pancreas (Inreda Diabetic BV)
Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype
• Insulin pump therapy
Patients' own insulin pump with fast-acting insulin analog

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
J.H. DeVries	European Commission, Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristics		Baseline	No
Other	Weight		Baseline	No
Other	Length		Baseline	No
Other	Insulin use		Day 1-4	No
Other	Glucagon use		Day 1-4	No
Primary	Mean sensor glucose concentration		Day 2-4	No
Secondary	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)	Day 2-4	Yes
Secondary	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)	Day 2-4	Yes
Secondary	Number of carbohydrate-treated hypoglycemic events		Day 2-4	Yes
Secondary	Proportion of time spent in euglycemia (= 3.9 mmol/l and = 10 mmol/l)		Day 2-4	No
Secondary	Glycemic variability	Calculated as Interquartile Range (IQR)	Day 2-4	No
Secondary	Mean sensor glucose concentration during specific periods	Periods: Day; Night; Postprandial	Day 2-4	No
Secondary	Mean absolute relative difference between sensor values and self-monitored blood glucose values		Day 2-4	No
Secondary	Heart rate		Day 2-4	No
Secondary	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).	Day 2-4	No
Secondary	Mean glucose concentration per day	Intervention arm (closed loop) only	Day 1-4	No
Secondary	Time that the control algorithm is inactive	Intervention arm (closed loop) only	Day 1-4	No