Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump — BIG LEAP  

Type1 Diabetes Mellitus Clinical Trial

Official title: Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump: A Comparison of Insulin Degludec to Continuous Subcutaneous Infusion of Insulin Aspart for Basal Insulin Delivery in Type 1 Diabetes

Status Completed

Clinical Trial Summary

The purpose of this investigator-initiated trial is to compare the effect of a daily injection of insulin degludec vs. basal insulin delivery via Continuous Subcutaneous Insulin Infusion (CSII), both in combination with bolus insulin delivery via the patient's usual insulin pump with insulin aspart, on glycemic variability, overall blood glucose control and incidence of hypoglycemia, all assessed by continuous glucose monitor (CGM), as well as patient satisfaction, in patients with type 1 diabetes currently using CSII.

Clinical Trial Description

The primary objective of this trial is to determine whether insulin degludec will provide an equally stable and consistent basal glycemic profile with lower glycemic variability as determined by Continuous Glucose Monitoring compared to insulin aspart delivered by Continuous Subcutaneous Insulin Infusion in patients with type 1 diabetes experienced in use of insulin pump therapy. Specifically, this study will determine if the percent time in the target glycemic range (70 to 180 mg/dl) by Continuous Glucose Monitoring is superior using insulin degludec than continuously infused insulin aspart, and if degludec is associated with lower glucose variability as assessed by the standard deviation (SD) of the mean daily glucose by Continuous Glucose Monitoring. Particular attention will be given to the nocturnal glucose profile (from midnight to 6 am) which most closely reflects basal insulin action as it is typically the time of day least affected by bolus insulin, food intake or exercise. Quality of life questionnaires regarding treatment preference will be used to capture patient preference for method of basal insulin delivery.

RESEARCH DESIGN AND METHODS

Study hypothesis:

It is anticipated, based on the low glycemic variability of insulin degludec shown in glucose clamp studies and seen in clinical practice, that insulin degludec will provide more stable 24 hour basal insulin action than insulin aspart by Continuous Subcutaneous Insulin Infusion (CSII) in patients with type 1 diabetes.

Primary endpoint:

Percent time in euglycemia (BG 70 to 180 mg/dl) by Continuous Glucose Monitoring (CGM) during the final 14 days of each treatment period during steady state (with basal insulin delivery as either one daily injection of insulin degludec or as insulin aspart via CSII).

Study type:

This will be a randomized, cross-over, open label, single-center study consisting of a 20 week period on each of two basal insulin delivery methods, both in combination with insulin aspart with boluses taken by insulin pump. Each 20 week period will consist of a 4 week insulin optimization period for titration of basal and bolus insulin doses, followed by a 16 week maintenance period. The final 2 weeks of the maintenance period during each treatment arm will be used for endpoint data collection. The treatment sequence will occur in random order. The study population will include patients with type 1 diabetes with good baseline glycemic control who are experienced in the use of both CSII and CGM; the cross-over design allows each subject to serve as his or her own control. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

• NCT number: NCT04409587
• Study type: Interventional
• Source: Mountain Diabetes and Endocrine Center
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2018
• Completion date: November 1, 2020