Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Patient's insulin pump; Drug: Insulin; Device: Dexcom G4 Platinum glucose sensor; Other: Single-hormone closed-loop

• Registration Number: NCT02774876
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

Brief Summary

Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. The objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Study Start: 2016-06
• Status Verified: 2017-07
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Males and females ≥ 18 years old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months and currently using fast-acting insulin analog (Lispro, Aspart or Guilisine).
4. Last (less than 3 months) HbA1c ≤ 10%.

Exclusion Criteria

1. 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.
2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Ongoing pregnancy.
4. Severe hypoglycemic episode within 1 month of screening.
5. Agents affecting gastric emptying (Motilium®, Prandase®, all GLP-1 analogs) 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.
6. 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®). Inhaled steroids at stable dose in the last month are acceptable.
7. 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).
8. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbohydrate meal	Patient's insulin pump	-
Carbohydrate meal	Insulin	-
Carbohydrate meal	Dexcom G4 Platinum glucose sensor	-
Carbohydrate meal	Single-hormone closed-loop	-
Carbohydrate + fat meal	Patient's insulin pump	-
Carbohydrate + fat meal	Insulin	-
Carbohydrate + fat meal	Dexcom G4 Platinum glucose sensor	-
Carbohydrate + fat meal	Single-hormone closed-loop	-
Carbohydrate + protein meal	Patient's insulin pump	-
Carbohydrate + protein meal	Single-hormone closed-loop	-
Carbohydrate + protein meal	Insulin	-
Carbohydrate + protein meal	Dexcom G4 Platinum glucose sensor	-
Carbohydrate + fat + protein meal	Patient's insulin pump	-
Carbohydrate + fat + protein meal	Insulin	-
Carbohydrate + fat + protein meal	Dexcom G4 Platinum glucose sensor	-
Carbohydrate + fat + protein meal	Single-hormone closed-loop	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of sensor glucose levels	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.

Secondary Outcome Measures

Name	Time	Method
Time to peak glucose	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Mean sensor glucose levels	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Peak glucose excursion	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Percentage of time of sensor glucose concentrations above 10 mmol/L	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Percentage of time of sensor glucose concentrations above 13.9 mmol/L	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Total insulin delivery	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Standard deviation of glucose levels	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Coefficient of variation of glucose levels	The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montreal, Quebec, Canada