Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

NCT02189694 | Completed Phase 2

• 1 other identifier: CLASS-08
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Hypoglycemia; Insulin; Glucagon; Closed-loop system; Artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of time of glucose levels spent below 4.0 mmol/L.

  Up to 8 hours

Secondary Outcomes (15)

• Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L

  Up to 8 hours

• Percentage of time of glucose levels spent below 3.5 mmol/L

  Up to 8 hours

• Percentage of time of glucose levels spent below 3.3 mmol/L

  Up to 8 hours

• Percentage of time of glucose levels spent above 8 mmol/L

  Up to 8 hours

• Percentage of time of glucose levels spent above 10 mmol/L.

  Up to 8 hours

Study Arms (3)

Insulin pump therapy

ACTIVE COMPARATOR

Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..

Device: Insulin pump therapy

Single-hormone closed-loop strategy

ACTIVE COMPARATOR

Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.

Device: Single-hormone closed-loop strategy

Dual-hormone closed-loop strategy

ACTIVE COMPARATOR

Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

Device: Dual-hormone closed-loop strategy

Interventions

Single-hormone closed-loop strategy DEVICE

Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.

Single-hormone closed-loop strategy

Dual-hormone closed-loop strategy DEVICE

Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.

Dual-hormone closed-loop strategy

Insulin pump therapy DEVICE

Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.

Insulin pump therapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females between the 8 and 17 years of old.
• Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
• HbA1c ≤ 11.0%.

You may not qualify if:

• Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
• Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
• Known or suspected allergy to the trial products.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
• Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Montreal Children's Hospital of the MUHC: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.

  PMID: 26066705 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Medicine

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 14, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

CA (1)