Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05936203 |
| Other study ID # |
Prot. 14/22 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2023 |
| Est. completion date |
February 15, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare three different therapeutic and nutritional
approaches during a prolonged aerobic exercise in moderately active type 1 diabetes people
using advanced technologies, to identify the best strategy for the management of this type of
exercise. Participants will be randomly assigned to different interventions in three
different occasions: insulin therapy adjustment; nutritional adjustment; combination of
insulin and nutritional adjustment.
Description:
Regular exercise is recommended in people with type 1 diabetes (T1D) for its several health
benefits (increased cardiovascular fitness, greater muscle strength, improved insulin
sensitivity). However, therapeutic, and nutritional management of physical exercise is
complex due to the multiple intra- and interindividual factors influencing glycemic response
to exercise in T1D people. Glucose levels can increase, stay stable, or decrease depending on
the type, duration, and intensity of exercise. During prolonged aerobic exercise, there is an
increase in the risk of hypoglycemia also in patients using advanced technologies such as the
hybrid artificial pancreas (HAP). The HAP consists of a continuous glucose monitoring (CGM)
sensor and an insulin pump connected by a control algorithm that infuses insulin based on the
glucose value recorded by the CGM sensor. With HAP there is the possibility to set a higher
glucose target to make the insulin doses less aggressive during a scheduled session of
physical exercise thus reducing the risk of hypoglycemia. However, there are different
approaches, including insulin therapy adjustments or consumption of carbohydrates, proposed
to minimize glycemic excursions during prolonged aerobic exercise in patients with T1D.
Currently, the best strategy to manage physical exercise in people with type 1 diabetes on
HAP, is not defined.
So, the aim of this study is to identify the optimal strategy for the management of prolonged
aerobic exercise in moderately active T1D patients using hybrid artificial pancreas
treatment. The exercise consists of an outdoor walk of 10 km over 4 hours and a height
difference of 200-300 m. Each participant will be randomly assigned to three different
therapeutic and nutritional interventions on three different occasions: 1)Target, which
consists in setting a higher glucose target from 1 hour before until the end of the walk; 2)
Snack, which consists of the consumption of 15 g of complex carbohydrates as whole grain
crackers every 30 minutes, during the 4 hours of the walk; 3) Target+Snack consists in the
combination of both Target and Snack interventions. Glycemic control expressed as CGM metrics
and insulin doses delivered by HAP during the 4 hours of walks will be assessed.
