Type1diabetesMARTA-walkNCT05936203
Management of Prolonged Aerobic exeRcise in Patients With Type 1 Diabetes on Advanced Technologies
A study testing Insulin therapy adjustment, Nutritional adjustment and Combination of strategies in people with Type1diabetes, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Insulin therapy adjustment, Nutritional adjustment and Combination of strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Using of hybrid artificial pancreas
Who cannot join
- Health conditions that may affect the safe performance of physical activity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Prolonged Aerobic Exercise in Patients With Type 1 Diabetes on Advanced Technologies
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- Insulin therapy adjustment, Nutritional adjustment, Combination of strategies
- Keywords
- prolonged aerobic exercise, hybrid artificial pancreas, carbohydrates supplementation, insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin therapy adjustmentOther
Strategies used to manage glucose control during a prolonged aerobic exercise
Nutritional adjustmentOther
Strategies used to manage glucose control during a prolonged aerobic exercise
Combination of strategiesOther
Strategies used to manage glucose control during a prolonged aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Target | Experimental | Setting a higher glucose target starting from 1 hour before until the end of walk. Receives: Other: Insulin therapy adjustment |
| Snack | Experimental | Consumption of 15 g of complex carbohydrates as whole grain crackers every 30 minutes, during the 4 hours of walk. Receives: Other: Nutritional adjustment |
| Target + Snack | Experimental | Combination of both Target and Snack interventions. Receives: Other: Combination of strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Glucose 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.
Measured: During 4 hours of walks in 3 different occasions
Insulin doses delivered
Total insulin doses delivered by HAP during 4 hours of walks will be downloaded from the dedicated platforms.
Measured: During 4 hours of walks in 3 different occasions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start11 Jan 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Annuzzi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936203
- Sponsor's protocol ID
- Prot. 14/22
- Acronym
- MARTA-walk
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Prolonged Aerobic Exercise in Patients With Type 1 Diabetes on Advanced Technologies
- ClinicalTrials.gov ID
- NCT05936203
- Acronym / sponsor ID
- MARTA-walk / Prot. 14/22
- Conditions
- Type1diabetes
- Keywords
- prolonged aerobic exercise, hybrid artificial pancreas, carbohydrates supplementation, insulin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Target | Experimental | Other: Insulin therapy adjustmentSetting a higher glucose target starting from 1 hour before until the end of walk. |
| Snack | Experimental | Other: Nutritional adjustmentConsumption of 15 g of complex carbohydrates as whole grain crackers every 30 minutes, during the 4 hours of walk. |
| Target + Snack | Experimental | Other: Combination of strategiesCombination of both Target and Snack interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Using of hybrid artificial pancreas
Key exclusion criteria (2 listed)
- Health conditions that may affect the safe performance of physical activity
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin therapy adjustmentStrategies used to manage glucose control during a prolonged aerobic exercise | Other | Target |
| Nutritional adjustmentStrategies used to manage glucose control during a prolonged aerobic exercise | Other | Snack |
| Combination of strategiesStrategies used to manage glucose control during a prolonged aerobic exercise | Other | Target + Snack |
Primary outcome
Time in Range
Time frame: During 4 hours of walks in 3 different occasions
Glucose 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 delivered
Time frame: During 4 hours of walks in 3 different occasions
Total insulin doses delivered by HAP during 4 hours of walks will be downloaded from the dedicated platforms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin therapy adjustment, Nutritional adjustment and Combination of strategies in people with Type1diabetes, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: During 4 hours of walks in 3 different occasions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.