Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes

NCT01074801 | Completed Phase 2

• 1 other identifier: DAN01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in this population extremely challenging. Our ongoing research focuses on the development of a closed-loop glucose control in children and adolescents with T1D. The three components of the closed-loop system are a continuous glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus far evaluated the efficacy and safety of overnight closed-loop glucose control. The results showed that overnight closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time period, including the daytime, when normal living activities occur. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D. The present study adopts an open-label, randomised, 2-period cross-over design whereby the safety and efficacy of closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be randomised for two 36 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). During both studies participants will perform normal daily activities, i.e. playing, reading, snacking and physical activity. On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to accurately quantify each subject's individual physical activity energy expenditure during the 36 hour study period and for 36 hours of free living during weekday.

Conditions

Type 1 Diabetes

Keywords

Closed-loop systems; day-and-night glucose control

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0 mmol/L) between 24:00 on Day 1 to 08:00 on Day 3.

  32 hours

Secondary Outcomes (1)

• Secondary outcomes will include: (i) Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours) (ii) CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)

  36 hours

Study Arms (2)

Closed-loop

ACTIVE COMPARATOR

Subcutaneous insulin delivery to be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings

Other: Closed-loop insulin delivery

Control arm

ACTIVE COMPARATOR

Subcutaneous insulin delivery to be administered according the standard insulin pump settings

Other: Standard insulin pump treatment

Interventions

Closed-loop insulin delivery OTHER

Basal subcutaneous insulin delivery to be adjusted at 15min cycles according to the computer-based algorithm advice.

Closed-loop

Standard insulin pump treatment OTHER

Subcutaneous insulin delivery to be performed based on subjects' standard treatment

Control arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 for at least 3 months, with good knowledge of insulin self-adjustment
• HbA1c ≤ 12% based on analysis from central laboratory

You may not qualify if:

• 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
• Postmenarchal girls who are pregnant or intending to become pregnant or are breastfeeding
• Any coexisting cardiac and respiratory condition (including asthma)

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, CB20QQ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roman Hovorka, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 6, 2011

Record last verified: 2010-02

Locations

GB (1)