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Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing

NCT01629251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-06-27

No results posted yet for this study

Summary

The main focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. After having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can be associated with the occurrence of postprandial hypoglycaemia, thus representing a confounding factor of hypoglycaemia free glucose control during the day. A further investigation is needed to evaluate alternative strategies for prandial insulin dosing. We will study eight adolescents with type 1 diabetes during closed-loop insulin delivery combined with either standard or reduced insulin doses with the meals, in a randomised crossover design. Stable glucose isotopes will be administered to collect data for modelling of glucose turnover around the meals, during daily activities and overnight.

The information provided by the use of glucose isotopes would be very helpful to increase our understanding of the physiology of glucose turnover and to facilitate the development of an improved control algorithm. Ultimately this study will help with the development of a closed-loop system to match insulin infusions to change in glucose levels in real life conditions.

Conditions

Interventions

DEVICE

Closed-loop insulin delivery

Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard or reduced meal insulin dosing will be performed in a randomised design.

Sponsors & Collaborators

Principal Investigators

  • Roman Hovorka, PhD · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629251 on ClinicalTrials.gov