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Completed

NCT Number: NCT01629251

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, CB20QQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop insulin delivery

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.

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: 36hours

    The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0mmol/L) between 24:00 on Day 1 and 08:00 on Day 3 (32 hours) as obtained with closed-loop insulin delivery in comparison with conventional insulin pump therapy.

Secondary outcomes

  1. Secondary efficacy endpoints

    Time frame: 36 hours

    • Total and basal insulin delivery between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)
    • CGM glucose levels between 24:00 on Day 1 and 08:00 on Day 3 (36 hours)
    • Overnight glucose levels between 24:00 on Day 1 and 08:00 on Day 2 (8 hours), and between 24:00 on Day 2 and 08:00 on Day 3 (8 hours)

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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