Es werden Patient mit Typ1 Diabetes gesucht, die Freude am Fahrrad fahren haben.

Austrian Exercise Study: Closed loop insulin delivery systems in Diabetes mellitus type 1 during prolonged physical activity, 20.09.-14.10.2019 in Vienna

MedVienna-Ärztezentrum/ Verein zur Förderung der wisssenschaftlichen Forschung am Wilhelminenspital Austria

Dr. Michael Müller-Korbsch, Dr. Lisa Frühwald, Dr. Maria Fangmeyer-Binder, David Reinhardt-Micocki, Prof. Peter Fasching

Background:

For about 2 years, insulin pumps have been used for the therapy of type 1 diabetes mellitus, which perform automatically the insulin dosage after continuous tissue sugar measurement, without specifications made by patients. There are systems that control with insulin only, and those that do a dual application with insulin and glucagon. Currently one is already a hybrid closed loop system approved with insulin Medtronic MiniMed 670G.The closed loop as well as the hybrid closed loop work very well in the patient's day, and the question comes up how good these systems can keep the sugar in the target range 70-180 mg/dl during prolonged aerobe exercise. Therefore, a study with a bike riding tour along the danube river with 15 patients with type 1 diabetes is planned.

Experimental:

15 adult patients with a type 1 diabetes mellitus treated over a period of 2 months with a CGM controlled insulin pump therapy were included. A closed insulin only AP-system is used for 15 patients.

The first two weeks are initially used to adjust the patients to the therapy and to document the glucose control in the everday life. The AP-System works alone and the patients receive alarms to monitor the system. An emergency call number for help is available. The data collected from the patient can be read from the memories of CGM systems and as of the insulin pumps.

CGM-systems and hybrid closed loop Insulin pump with rapid-acting insulin analogues aspart, lispro, glulisin and Faster Insulin Aspart.

A bike exercise tour with about 49 km along the river danube with 100 meter of altitude will be done twice on two following days.

All carbohydrates added one hour before during and 10 min. after physical activity are recorded to reach the primary target range of glucose with 70-180 mg/dl.

All subjects will also receive a heart rate measuring system for documentation of the physical load. (Polar beat H7)

Measuring of blood glucose, blood ketones and saliva cortisol at the beginning and every hour during the exercise session will be done.

Primary Objective: Additional carbohydrates consumed to maintain glucose in the target range of 70-180 mg/dl
Second Objective Time in the target range 70-180 mg / dl, time below 54 mg/dl and below 70 mg/dl, glucose variability, mean glucose.

 Carb intake: fast-acting carbohydrates dextrose and fluid maltodextrin with fructose are used.

The following amount have to be taken every half an hour:

CGM-Value 70-80 mg/dl: 5 gr CHO

CGM-Value 60-70 mg/dl: 10 gr CHO

CGM-Value 50-60 mg/dl: 15 gr CHO

The primary target range for glucose is 70-180 mg/dl.

Study Procedure:

Day1: 20.09.2019 um 16 Uhr:  Come together, Information and consent of the patient to evaluate the data, check the equipment to full functionality and features of patients with study equipment CGM-systems, Automated Insulin Delivery System survey, the lab from the last two months: hbA1c, kreatinin, natrium, potassium, TSH, blood count, setting optimization in the insulin pump, setting the CGM system.

Day8: 04.10.2019:

Day16: Tour 1: 12.10.2019: 9.30 Uhr:

Meeting together and driving the tour for the first time. During the bike tour at the beginning and every hour during the cycling blood ketons, blood glucose and saliva cortisol were taken for safety reasons. During the exercise the needed fast-acting carbohydrates are dextrose and fluid maltodextrin with fructose. All subjects will also receive a heart rate measuring system for documentation of the physical load.

  Day17: Tour 2 13.10.2019 9.30 Uhr : Start at Neue Donau in Vienna. 60 minutes before the start the target values of the pump settings were bring to 150 mg/dl. After that intervention the patient can eat the necessary carbohydrates to come to the level of 150 mg/dl. It is not allowed to do any physical activity before the bike session. The breakfast with bread and cereal take place at least 2 hours before the bike tour. Meeting together and driving the tour for the second time with the new algorithm. During the exercise the needed fast-acting carbohydrates are dextrose and fluid maltodextrin with fructose. During the exercise the fast-acting carbohydrates are dextrose and fluid maltodextrin with fructose.

Day18: 14.10.2019

Driving map: