NCT00944619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 12, 2010

Status Verified

January 1, 2010

Enrollment Period

3 months

First QC Date

July 21, 2009

Last Update Submit

May 10, 2010

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of plasma glucose values in target (3.9-8.0 mmol/L)

    2200-1200hr

Secondary Outcomes (10)

  • Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)

    2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

  • Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)

    0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

  • Percentage of plasma glucose and CGM values below 3.9 mmol/L

    2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

  • Percentage of plasma glucose and CGM values above 8.0 mmol/L

    2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

  • Average plasma and CGM glucose

    2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

  • +5 more secondary outcomes

Study Arms (2)

Closed loop (algorithm)

EXPERIMENTAL

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

Device: Closed loop

Open loop

PLACEBO COMPARATOR

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Device: Conventional insulin pump delivery

Interventions

Closed loopDEVICE

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

Closed loop (algorithm)
Conventional insulin pump deliveryDEVICE

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Open loop

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (1)

  • Hovorka R, Kumareswaran K, Harris J, Allen JM, Elleri D, Xing D, Kollman C, Nodale M, Murphy HR, Dunger DB, Amiel SA, Heller SR, Wilinska ME, Evans ML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011 Apr 13;342:d1855. doi: 10.1136/bmj.d1855.

    PMID: 21493665DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mark L Evans, MD FRCP

    University of Cambridge, UK

    PRINCIPAL INVESTIGATOR

  • Roman Hovorka, PhD

    University of Cambridge, UK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 12, 2010

Record last verified: 2010-01

Locations

GB(1)