The Banana Exercise Type 1 Diabetes Study

NCT ID: NCT06917274

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No banana

No banana consumed prior exercise

Group Type ACTIVE_COMPARATOR

No banana

Intervention Type OTHER

No banana is consumed pre-exercise

banana

Banana consumed 20 minutes prior exercise

Group Type ACTIVE_COMPARATOR

Banana

Intervention Type DIETARY_SUPPLEMENT

A banana is consumed pre-exercise in order to prevent hypoglycemia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Banana

A banana is consumed pre-exercise in order to prevent hypoglycemia

Intervention Type DIETARY_SUPPLEMENT

No banana

No banana is consumed pre-exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* type 1 diabetes

Exclusion Criteria

* cardiovascular comorbidity
* neuropathy
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rakel Johansen, MD

Role: CONTACT

+45 40530612

Esben Vestergaard, MD

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-9-25

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise Detection Study
NCT02688218 COMPLETED NA
Discovery Diabetes
NCT07116434 RECRUITING NA