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

NCT ID: NCT01629251

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-09-30

Brief 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

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loop with standard meal insulin bolus

Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard meal insulin dosing will be performed at each meal, following individual standard clinical practice.

Group Type: ACTIVE_COMPARATOR

Closed-loop insulin delivery

Intervention Type: DEVICE

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.

Closed-loop with reduced meal insulin bolus

Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. The standard meal insulin dose will be reduced by 20 to 50%.

Group Type: EXPERIMENTAL

Closed-loop insulin delivery

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject is between 12 and 18 years of age (inclusive).
• The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
• The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
• HbA1c ≤ 12 % based on analysis from central laboratory

Exclusion Criteria

• Non-type 1 diabetes mellitus including those secondary to chronic disease
• Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
• Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
• Known or suspected allergy against insulin
• Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
• Total daily insulin dose >= 2 IU/kg
• Post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding
• Any coexisting cardiac and respiratory condition

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Dr Roman Hovorka

Principal Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Hovorka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, , United Kingdom

Countries

United Kingdom

References

Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.

Reference Type: BACKGROUND

PMID: 20138357 (View on PubMed)

Other Identifiers

DAN02

Identifier Type: -

Identifier Source: org_study_id