Prevention of Severe Hypoglycemia in Type 1 Diabetes

What Was Tested

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

Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes.

Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion.

The registry classes the interventions as device and drug.

More on the Plan

The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions: 1.

Who Took Part

21 planned participants were the target.

It was open to people of any sex aged from 18 years up to 74 years.

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

Examples of who could join: Type 1 diabetes. Recurrent severe hypoglycemia within the preceding 6 months.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen; previous use of continuous subcutaneous insulin infusion pump; alcohol or drug abuse.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2003-05 with completion listed for 2004-09.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example incidence of mild symptomatic hypoglycemia, HbA1C, Continuous Subcutaneous Glucose Monitoring System profiles, Altered Hypoglycemia Awareness survey, Hypoglycemia Fear Survey and Diabetes Quality Of Life of questionnaires.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 21 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.