High-intensity training as a novel treatment for impaired awareness of hypoglycaemia in type 1 diabetes [HIT4HYPOS]: Protocol for a randomized parallel-group study.

Aim: This pilot study aimed to investigate whether a 4-week programme of intermittent high-intensity training (HIT) will improve counterregulatory responses and improve hypoglycaemia awareness in adults with type 1 diabetes who have been exposed to recurrent hypoglycaemia.
Methods: Adults with type 1 diabetes who have been exposed to recurrent hypoglycaemia will be recruited from NHS Tayside, Scotland. All participants have a 4-week run-in period to optimize glycaemic control and to receive instruction in hypoglycaemia avoidance using insulin dose adjustment and real-time continuous glucose monitoring (CGM). Following this, they will undergo a baseline 90-minute hyperinsulinaemic hypoglycaemic clamp to assess symptomatic, cognitive and hormonal counterregulatory responses. Subsequently, participants will be randomized in a parallel-group design to either undergo a 4-week intervention with HIT or to no exercise with both groups using CGM throughout and receiving additional advice on hypoglycaemia avoidance. Participants in the HIT arm of the trial will be instructed to exercise 3 times a week on a cycle ergometer and asked to achieve ≥ 90% max heart rate during each period of exercise. On completion of the intervention period, all subjects then undergo a second matched hyperinsulinaemic hypoglycaemic clamp study. Discussion: This pilot study will determine whether high-intensity exercise may offer a novel approach to restore hypoglycaemic awareness in type 1 diabetes (International Standard Randomised Controlled Trials No: ISRCTN15373978).

RCT Entities:   Population Interventions Outcomes