NCT00910767

Brief Summary

The main objective of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes.

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 Feb 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

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

May 28, 2009

Last Update Submit

September 16, 2009

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    1900 to 0800hr

Secondary Outcomes (25)

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

    1900 to 0800hr

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

    0000 to 0800hr

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

    0800 to 1200hr

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

    1900 to 0800hr

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

    0000 to 0800hr

  • +20 more secondary outcomes

Study Arms (2)

Closed loop (algorithm)

EXPERIMENTAL
Device: Closed loop

Open loop

PLACEBO COMPARATOR
Device: Conventional insulin pump delivery

Interventions

Conventional insulin pump deliveryDEVICE

Subcutaneous delivery of Novorapid insulin according to usual pump regime

Open loop
Closed loopDEVICE

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

Closed loop (algorithm)

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 the results
  • Known/suspected allergy against insulin
  • Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  • Ongoing severe recurrent hypoglycaemia as judged by the investigator.

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

May 28, 2009

First Posted

June 1, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

GB(1)