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Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes

2016-06-27 20:53:21 | BioPortfolio

Summary

The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of pramlintide with insulin at meal times improves glucose control in type 1 diabetes.

The purpose of this study is to compare the effectiveness of 2 strategies to control your day-and-night glucose levels: 1) insulin-plus-placebo closed-loop delivery and 2) insulin-plus-pramlintide closed-loop delivery.

The hypothesis is that a basal-bolus infusion of insulin-plus-pramlintide in the closed-loop system will improve blood glucose control compared to insulin-plus-placebo infusion.

Description

The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of pramlintide with insulin at meal times improves glucose control in type 1 diabetes.

The aim of the study is to assess the efficacy of the simultaneous, closed-loop, basal-bolus infusion of pramlintide and insulin with fixed ratio (i.e., mimicking co-formulation) in controlling glucose levels compared to insulin-plus-placebo closed-loop infusion.

The investigators aim to conduct a double-blinded, randomized, crossover trial to compare the efficacy of insulin-plus-placebo closed-loop delivery and insulin-plus-pramlintide closed-loop delivery in regulating glucose levels over a period of 24 hours in a study of adults in inpatient settings. At a minimum of ten days prior to the closed-loop interventions, pramlintide or a placebo will be initiated (basal and bolus) using a second pump.

The hypothesis is that a basal-bolus infusion of insulin-plus-pramlintide in the closed-loop system will improve blood glucose control compared to insulin-plus-placebo infusion.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 1

Intervention

24-hour inpatient intervention, Exercise sub-study intervention, Meal sub-study intervention

Location

McGill University Health Centre
Montréal
Quebec
Canada

Status

Not yet recruiting

Source

McGill University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-27T20:53:21-0400

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