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Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Dual-hormone closed-loop

Insulin

Glucagon

Dexcom G4 Platinum glucose sensor

Accu Chek Combo insulin pump

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Artificial pancreas, Closed-loop system, Postprandial glucose control, Hypoglycemia, Insulin, Glucagon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females ≥ 18 years 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
Last (less than 3 months) HbA1c ≤ 10%.
Currently using carbohydrate counting as the meal insulin dose strategy.

Exclusion Criteria:

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.
Pregnancy.
Severe hypoglycemic episode within 1 month of screening.
Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).

Sites / Locations

Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dual-hormone CL with overestimation of meal size category

Dual-hormone CL with adequate estimation of meal size category

Arm Description

A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.

A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.

Outcomes

Primary Outcome Measures

Percentage of time below 4.0 mmol/L

Secondary Outcome Measures

Mean glucose

Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L

Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L

Percentage of time of glucose concentrations below 3.1 mmol/L

Area under the curve of glucose values below 4.0 mmol/L

Area under the curve of glucose values below 3.1 mmol/L

Number of patients with at least one hypoglycemic event with or without symptoms

Total number of hypoglycemic event below 3.1 mmol/L

Total carbohydrate intake for hypoglycemia correction

Total insulin delivery

Total glucagon delivery

Full Information

NCT ID

NCT02626936

First Posted

December 3, 2015

Last Updated

June 9, 2016

Sponsor

Institut de Recherches Cliniques de Montreal

1. Study Identification

Unique Protocol Identification Number

NCT02626936

Brief Title

Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation

Official Title

A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large) It is however important to establish safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of single and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer simulation will be used to get a reasonable estimate of risks related to over-estimation with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested in adults with type 1 diabètes Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Type 1 diabetes, Artificial pancreas, Closed-loop system, Postprandial glucose control, Hypoglycemia, Insulin, Glucagon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dual-hormone CL with overestimation of meal size category

Arm Type

Active Comparator

Arm Description

Arm Title

Dual-hormone CL with adequate estimation of meal size category

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Dual-hormone closed-loop

Intervention Description

Interventions will be undertaken one to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00 am. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, CLS will be initiated. At 9:00, a standardized breakfast (75g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions.The intervention day will end at 13:00.

Intervention Type

Drug

Intervention Name(s)

Insulin

Intervention Description

Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)

Intervention Type

Drug

Intervention Name(s)

Glucagon

Intervention Description

Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.

Intervention Type

Device

Intervention Name(s)

Dexcom G4 Platinum glucose sensor

Intervention Type

Device

Intervention Name(s)

Accu Chek Combo insulin pump

Primary Outcome Measure Information:

Title

Percentage of time below 4.0 mmol/L

Time Frame