Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes — PHYSI-DREAM  

Type 1 Diabetes Mellitus Clinical Trial

Official title: Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)

Status Completed

Clinical Trial Summary

The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the standard treatment without computer algorithm decisions - SAP therapy in 20 children and adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity.

The aims of the study are:

• to demonstrate that the use of DreaMed MD-AID is safe during physical activity

• to investigate the risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control.

Clinical Trial Description

This is investigator initiated, single-center, open-label, crossover, randomized, interventional, in-hospital pediatric study, performed at the University Children's Hospital, University Medical Center Ljubljana.

Study duration will be about 4 weeks per subject, 6 month overall. The study will compare Continuous Glucose Monitoring (CGM) based time in hypoglycemia in an intervention arm (Glucose control using DreaMed MD-AID) to a control arm (Glucose control using SAP).

Each arm includes two exercise days with 1 week in-between. Subjects will be randomly assigned to participate first in the intervention arm (10 subjects) or first in the control arm (10 subjects). At the end of the first period patients will be asked to participate in another, i.e. the other arm with at least one week between arms.

Subjects will be instructed to consume a similar diet and avoid caffeine, alcohol, and physical activity in the 48 hours before the exercise day visit.

The start of the run-in period can be scheduled as a separate visit, but not more than 2 days after screening.

All subjects will attend the clinic on six occasions:

• Visit 1: Screening and sensor/pump education, detailed physical examination will be performed, all subject will have to meet inclusion/exclusion criteria.

• Visit 2: Baseline assessment of the DreaMed MD-AID profile, subjects will perform resting electrocardiography (ECG) and determination of the maximal oxygen consumption rate (VO2max) on a cycle ergometer Ganshorn LF8.5G™ and Schiller software, with BG measurements before, at the end of the exercise and 2 hours after exercise. Subjects will be instructed to refrain from physical activity for 48 hours prior to visits 3 - 6.

• Visit 3: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM).The subjects will cycle for 40 minutes at 55% Vo2max load (starting work rate set to 30 watts (W) with linear loading to reach 55% VO2max on 5:00 minute exercise time) - the aim of this session is to induce delayed hypoglycemia.

• Visit 4: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM). The subjects will cycle for 40minutes - high intensity interval training (2 - 6 sprints of 20 seconds at 80% VO2max with interval of 6 minutes low-moderate activity (55% VO2max (total of ~40 minutes) between the sprint. The aim of this session is to imitate children's physical activity (bursts of intensive physical activity interspersed with varying intervals of activity of low and moderate intensity.

• Visit 5&6: Same as visits 3 and 4, cross over from DreaMed MD-AID to SAP or vice versa.

During the exercise, a continuous ECG will be recorded and inhaled O2 and exhaled Carbon Dioxide (CO2) will be measured.

BG and lactate will be taken during the exercise visits: at the beginning of the exercise, after every 15 min exercise session, and every half an hour for the next 2 hours thereafter.

All hypoglycemia will be confirmed with SBGM: glucose values <3.3 (60 mg/dl) mmol/l if symptomatic, and all hypoglycemia with self blood glucose monitoring (SBGM) values <2.8 mmol/l (50 mg/dl) (regardless of symptoms) will be treated with rescue carbohydrates as per standard in-hospital procedure (15 g sugar per 10 kg of body weight (BW), re-evaluate and repeat if necessary in 15-30 minutes).

New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.

Schedule for all exercise days will be similar:

• 12:00 hospital admission

• 13:00 lunch

• 13:30 to 16:00 rest

• 16:00 afternoon snack

• 16:30 to 19:30 exercise protocol

• 19:45 dinner

• 21:00 to 7:30 next day: bed time

• 8:00 breakfast.

• 13:00 lunch and end of study

Subjects will have standardized and similar meals on all exercise days (lunch at 13:00, afternoon snack at 16:00, dinner at 19:45, and breakfast at 8:00 the next day), based on the weight, with calculated carbohydrates and calories: 1 gram of carbohydrates per kilogram, the content of the meal according to the recommendation: comprising of 50% carbohydrate, 20% protein, and 30% fat, of which no more than 10% will be saturated fat. During the exercise the SAP group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

• NCT number: NCT02657083
• Study type: Interventional
• Source: University of Ljubljana, Faculty of Medicine
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Completion date: June 2016