Is supper necessary to prevent overnight hypoglycaemia when using Lantus insulin?

Is supper required to prevent nocturnal hypoglycaemia in children with Type 1 Diabetes, when using basal-bolus insulin regimens with long and rapid-acting analogue insulins?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000408482

Enrollment

Registered

2007-08-07

Start date

2007-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Children with diabetes are currently recommended to have a carbohydrate supper before bed when using insulin injections. This is done to avoid overnight hypoglycaemia (blood glucose levels below 4mmol/L). This advice is based on using insulins such as Protaphane. Some of the new insulins available, such as Lantus, do not have an action peak. With these new insulins, we think it is unlikely that a supper before bed is needed to prevent overnight hypoglycaemia. To our knowledge there are no research studies that have tested this idea. This project looks at testing overnight blood glucose levels with and without supper, when using multiple daily injections of insulin that includes Lantus. The results of this study will help us to know whether supper is needed when using Lantus insulin.

Interventions

The proposed study will use Continuous Glucose Monitoring System (CGMS) devices to compare the nocturnal glycaemic outcomes of having a carbohydrate supper (control) versus having no supper (intervention) to determine whether a carbohydrate-containing snack before bed is required to prevent hypoglycaemia. Supper will consist of a dairy snack containing 15 grams of carbohydrate. The study duration is 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Healthy volunteers

Inclusion criteria

Diagnosed with Type 1 Diabetes for greater than 1 year. Insulin regimen: established on a basal-bolus insulin regimen using glargine once daily and lispro/aspart (rapid-acting insulin) as evening bolus.HbA1c <8%Not currently on any other dietary restrictions.

Exclusion criteria

HbA1c > 8%Currently on other dietary restrictionsInsulin regimen: using isophane or other intermediate insulinsNon-English speaking.

Outcome results