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Management of Prolonged Aerobic exeRcise in Patients With Type 1 Diabetes on Advanced Technologies

Management of Prolonged Aerobic Exercise in Patients With Type 1 Diabetes on Advanced Technologies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05936203
Acronym
MARTA-walk
Enrollment
18
Registered
2023-07-07
Start date
2023-01-11
Completion date
2024-02-15
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes

Keywords

prolonged aerobic exercise, hybrid artificial pancreas, carbohydrates supplementation, insulin therapy

Brief 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.

Detailed 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.

Interventions

OTHERInsulin therapy adjustment

Strategies used to manage glucose control during a prolonged aerobic exercise

OTHERNutritional adjustment

Strategies used to manage glucose control during a prolonged aerobic exercise

OTHERCombination of strategies

Strategies used to manage glucose control during a prolonged aerobic exercise

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Randomized crossover clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Type 1 diabetes * Using of hybrid artificial pancreas

Exclusion criteria

* Health conditions that may affect the safe performance of physical activity * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Time in RangeDuring 4 hours of walks in 3 different occasionsGlucose concentrations at 5-min intervals will be downloaded from dedicated platforms and the percentage of time with a glycemia between 70-180 mg/dl during 4 hours of walks will be derived.
Insulin doses deliveredDuring 4 hours of walks in 3 different occasionsTotal insulin doses delivered by HAP during 4 hours of walks will be downloaded from the dedicated platforms.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026