How much additional insulin is needed for fat and protein meals in people with type 1 diabetes using insulin pumps.

Establishment of an insulin dosing schedule for high fat, high protein meals in individuals with type 1 diabetes using insulin pump therapy.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000082909

Acronym

HFHP pump

Enrollment

Registered

2020-01-31

Start date

2017-10-25

Completion date

2019-09-02

Last updated

2020-02-10

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

Conditions

None listed

Brief summary

Research has shown that in addition to carbohydrate, fat and protein in foods cause a delayed rise in blood glucose. In some people with type 1 diabetes meals higher in fat and protein require extra insulin. This is a 4 day, home- based study looking at how much extra insulin to give for meals higher in fat and protein. We hypothesise that administration of an additional 60% of the meal insulin dose will reduce mean glucose excursions at 180 mins post- meal without an increase in hypoglycaemia.

Interventions

This study involves the provision of the same high fat, high protein (40g fat, 50g protein) breakfast meal with insulin for 4 days (consecutive). The total amount of insulin administered on each of the 4 days will vary. Meal insulin will be calculated using the participant’s usual insulin to carbohydrate ratio (ICR), 100% (control), 120%, 140%, 160% ICR and given as a combination bolus split in a 60:40 ratio over 3 hours. Postprandial glucose will be measured using continuous glucose monitoring

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

8 Years to 25 Years

Healthy volunteers

Inclusion criteria

• T1DM for more than 1 year • Using insulin pump therapy • HbA1c less than or equal to 64 mmol/mol (8.0%) • Body mass index less than the 95th percentile

Exclusion criteria

• Coexisting medical problems • Evidence of complications of diabetes incl gastroparesis • Dietary restrictions (allergies/ intolerances) that prevent test meal consumption

Outcome results