The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Insulin Detemir.

This trial is conducted in Europe.

The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

The registry classes the interventions as drug.

Who Took Part

The registry lists 51 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 Diabetes. Current basal-bolus insulin therapy. BMI \< 32 kg/m2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: proliferative retinopathy / maculopathy; recurrent major hypoglycaemias; impaired hepatic or renal function.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2006-04 with completion listed for 2006-11.

It ran at 2 sites in Germany (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise (time frame: following 4 weeks of treatment).

It also tracked 4 secondary outcomes, for example Plasma glucose pre-exercise & post-exercise, Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning, Plasma glucose profile post-exercise and Incidence of adverse events during the trial.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 51 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Detemir compound page, all human trials.