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Not yet recruiting NCT06917274

The Banana Exercise Type 1 Diabetes Study

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Banana, No banana.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 15 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Pre-Exercise Banana Consumption on Glycemic Control in Individuals With Type 1 Diabetes

Overview

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.

Interventions

  • Dietary supplement Banana
    A banana is consumed pre-exercise in order to prevent hypoglycemia
  • Other No banana
    No banana is consumed pre-exercise

Primary outcome measures

  • CGM glucose [Time frame: approximately 60 minute monitoring period during exercise]
Secondary outcome measures (2)
  • Time to hypoglycemia [Time frame: approximately 30 to 30 minutes]
  • Borg scale [Time frame: Borg scale is assessed approximately 15 minutes after exercise]

Eligibility criteria

Inclusion criteria

  • type 1 diabetes

Exclusion criteria

  • cardiovascular comorbidity
  • neuropathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06917274 · 1-10-72-9-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗