Closing the Loop in Adults With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.

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Detailed Description

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People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.

We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed loop (algorithm)

Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings

Group Type EXPERIMENTAL

Closed loop

Intervention Type DEVICE

Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings

Open loop

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Group Type PLACEBO_COMPARATOR

Conventional insulin pump delivery

Intervention Type DEVICE

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Interventions

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Closed loop

Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings

Intervention Type DEVICE

Conventional insulin pump delivery

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
* On insulin pump therapy for at least 3 months

Exclusion Criteria

* Non-type 1 diabetes mellitus
* Any physical/psychological disease likely to interfere with the study
* Taking medication likely to interfere with interpretation of results
* Known/suspected allergy against insulin
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
* Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
* Current pregnancy/breastfeeding
* Total daily insulin dose \> 1.4 IU/kg
* HbA1C \> 10% within the last 3 months
* Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No