Normal Versus Dual Wave Insulin Bolus for High-protein Food

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: insulin glulisine; Drug: insulin lispro; Drug: insulin aspart

Study type: Interventional

Funder types: Other

Identifiers

NCT02276859

Protein Food Insulin Bolus

Details and patient eligibility

About

Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.

Full description

The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). The required insulin dose will be calculated based on patient's insulin-exchange ratio. A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic excursions will be identified using the CGMS.

Enrollment: 70 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• duration of type 1 diabetes longer than 12 months
• insulin pump therapy longer than 3 months
• written informed consent by patients and parents
• patients must be willing to wear a glucose sensor for two days
• insulin requirement more than 0,5 units/kg/day

Exclusion criteria

• concomitant dietary restrictions (e.g. celiac disease or food allergy)
• diabetes related complications (e.g. nephropathy)
• any disease judged by the investigator to affect the trial
• withdrawal of consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Normal/ Dual-wave

Experimental group

Description:

On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Treatment:

Drug: insulin aspart

Drug: insulin lispro

Drug: insulin glulisine

Dual-wave/Normal

Experimental group

Description:

On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Treatment:

Drug: insulin aspart

Drug: insulin lispro

Drug: insulin glulisine