Type 1 DiabetesNCT06917274
The Banana Exercise Type 1 Diabetes Study
A study testing Banana and No banana in people with Type 1 Diabetes, run by University of Aarhus.
Trial summary
Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Banana and No banana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- type 1 diabetes
Who cannot join
- cardiovascular comorbidity
- neuropathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Pre-Exercise Banana Consumption on Glycemic Control in Individuals With Type 1 Diabetes
Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Endpoints include differences in glucose levels, hypoglycemia events (SG <3.9 mmol/L), and Time in Range during training
Read the detailed description
Participants:
Former and current KADET athletes invited via a Facebook group. Previous participants in study projects who have expressed interest in being contacted for future studies.
Protocol:
Participants provide written consent for data collection and use.
Each participant completes two training sessions under controlled conditions, including:
Same training time Standardized pre-training meal timing and insulin corrections Similar intensity and environmental factors If pre-training hypoglycemia occurs, training is rescheduled or corrected with glucose tablets, which are documented.
Study Conditions:
Session 1: Participant eats a banana 20 minutes before training. Session 2: No pre-training food intake.
Tandem Control IQ users (insulin pump) take a microbolus (0.05 IE) before banana intake.
Recorded Data by participant:
Training start and end times Sensor glucose (SG) at start and end of training Training type and intensity (Borg scale, heart rate monitoring) Last insulin dose (meal and correction) Last meal details (content and timing) Banana documentation (photo, weight with peel, ripeness level)
CGM data are also assessed.
Endpoints:
Differences in GCG glucose level Time to hypoglycemia and number of hypoglycemia events (SG <3.9 mmol/L) on banana vs. non-banana days.
Percentage of Time in Range during training. Additional data is reported as available.
- Conditions
- Type 1 Diabetes
- Being tested
- Banana, No banana
- Keywords
- nutrition, CGM, blood glucose, exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BananaDietary supplement
A banana is consumed pre-exercise in order to prevent hypoglycemia
No bananaOther
No banana is consumed pre-exercise
| Study group | Role | What they receive |
|---|---|---|
| No banana | Active comparator | No banana consumed prior exercise Receives: Other: No banana |
| banana | Active comparator | Banana consumed 20 minutes prior exercise Receives: Dietary Supplement: Banana |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM glucose
CGM glucose Time in Range between 3.9 and 10 mmol/l
Measured: approximately 60 minute monitoring period during exercise
Secondary outcomes (2)
Time to hypoglycemia
minutes to hypoglycemia after exercise has begun
Measured: approximately 30 to 30 minutes
Borg scale
Level of excaution evaluated on Borg scale from 6-20
Measured: Borg scale is assessed approximately 15 minutes after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917274
- Sponsor's protocol ID
- 1-10-72-9-25
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-Exercise Banana Consumption on Glycemic Control in Individuals With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06917274
- Acronym / sponsor ID
- 1-10-72-9-25
- Conditions
- Type 1 Diabetes
- Keywords
- nutrition, CGM, blood glucose, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Endpoints include differences in glucose levels, hypoglycemia events (SG <3.9 mmol/L), and Time in Range during training
Detailed description
Participants:
Former and current KADET athletes invited via a Facebook group. Previous participants in study projects who have expressed interest in being contacted for future studies.
Protocol:
Participants provide written consent for data collection and use.
Each participant completes two training sessions under controlled conditions, including:
Same training time Standardized pre-training meal timing and insulin corrections Similar intensity and environmental factors If pre-training hypoglycemia occurs, training is rescheduled or corrected with glucose tablets, which are documented.
Study Conditions:
Session 1: Participant eats a banana 20 minutes before training. Session 2: No pre-training food intake.
Tandem Control IQ users (insulin pump) take a microbolus (0.05 IE) before banana intake.
Recorded Data by participant:
Training start and end times Sensor glucose (SG) at start and end of training Training type and intensity (Borg scale, heart rate monitoring) Last insulin dose (meal and correction) Last meal details (content and timing) Banana documentation (photo, weight with peel, ripeness level)
CGM data are also assessed.
Endpoints:
Differences in GCG glucose level Time to hypoglycemia and number of hypoglycemia events (SG <3.9 mmol/L) on banana vs. non-banana days.
Percentage of Time in Range during training. Additional data is reported as available.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No banana | Active comparator | Other: No bananaNo banana consumed prior exercise |
| banana | Active comparator | Dietary Supplement: BananaBanana consumed 20 minutes prior exercise |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- type 1 diabetes
Key exclusion criteria (2 listed)
- cardiovascular comorbidity
- neuropathy
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 |
|---|---|---|
| BananaA banana is consumed pre-exercise in order to prevent hypoglycemia | Dietary supplement | banana |
| No bananaNo banana is consumed pre-exercise | Other | No banana |
Primary outcome
CGM glucose
Time frame: approximately 60 minute monitoring period during exercise
CGM glucose Time in Range between 3.9 and 10 mmol/l
2 secondary outcomes
Time to hypoglycemia
Time frame: approximately 30 to 30 minutes
Borg scale
Time frame: Borg scale is assessed approximately 15 minutes after exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Banana and No banana in people with Type 1 Diabetes, run by University of Aarhus.
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 1 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakel Johansen, MD (+45 40530612, rfjohansen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM glucose (time frame: approximately 60 minute monitoring period during exercise). 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 8 Apr 2025.