Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

NCT01930097 | Completed Phase 2

• 1 other identifier: CLASS-05
• Study Type: interventional
• Target: 12
• 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control. Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The positive incremental area under the curve of postprandial glucose excursions

  The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.

  4 hours after meal intake

Secondary Outcomes (15)

• Mean plasma glucose

  8h00 to 21h00

• Incremental two hours postprandial glucose

  2 hours after meal intake

• Incremental postprandial peak-glucose values

  8h00 to 21h00

• Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L

  8h00 to 21h00

• Percentage of time of plasma glucose levels spent above 10.0 mmol/L

  8h00 to 21h00

Study Arms (3)

CHO-dependant bolus

ACTIVE COMPARATOR

An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.

Other: 14 hours intervention

CHO-independent bolus

ACTIVE COMPARATOR

An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.

Other: 14 hours intervention

Conventional treatment

ACTIVE COMPARATOR

Patients will use conventional pump therapy to regulate glucose levels

Other: 14 hours intervention

Interventions

14 hours intervention OTHER

Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).

CHO-dependant bolus; CHO-independent bolus; Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 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.
• Last (less than 3 months) HbA1c ≤ 12%.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
• Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
• Ongoing pregnancy.
• Severe hypoglycemic episode within two weeks of screening.
• Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
• Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
• Unusual nutritional habits (e.g. vegetarians)
• 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 eat snack, not willing to change pump parameters, etc).
• Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios
• Problems with venous access

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

Related Publications (1)

• Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10.

  PMID: 26072052 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

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: August 23, 2013
• First Posted: August 28, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

CA (1)