Clinical Trials Logo

Clinical Trial Summary

To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.


Clinical Trial Description

Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D) patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. Dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient.

As a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in T1D patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497260
Study type Interventional
Source University Hospital Inselspital, Berne
Contact Lia Bally, MD PhD
Phone + 41 31 632 40 70
Email lia.bally@insel.ch
Status Not yet recruiting
Phase N/A
Start date January 2019
Completion date December 2019

See also
  Status Clinical Trial Phase
Completed NCT03293082 - Preschool CGM Use and Glucose Variability in Type 1 Diabetes N/A
Recruiting NCT02527265 - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Active, not recruiting NCT03240432 - Wireless Innovation for Seniors With Diabetes Mellitus N/A
Recruiting NCT03168867 - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) N/A
Recruiting NCT03260868 - Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy) Phase 4
Not yet recruiting NCT03262116 - Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas N/A
Completed NCT02882737 - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring N/A
Completed NCT02529449 - Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus Phase 2
Completed NCT02558491 - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM N/A
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02562313 - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog® Phase 1
Recruiting NCT02213003 - Allogeneic Islet Cells Transplanted Onto the Omentum Phase 1/Phase 2
Active, not recruiting NCT02175732 - Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes N/A
Active, not recruiting NCT02239354 - A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus Phase 1/Phase 2
Completed NCT02232698 - An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) N/A
Completed NCT01945060 - Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator N/A
Completed NCT01683266 - Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus Phase 3