Type 1 Diabetes Clinical Trial
Verified date | April 2017 |
Source | Institut de Recherches Cliniques de Montreal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the safety of this simplified
meal bolus approach. The safety of overestimating a meal insulin bolus in the context of
closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone
closed-loop will be tested.
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 a fast acting insulin analog (Lispro, Aspart or Glulisine). 4. Last (less than 3 months) HbA1c = 10%. 5. Currently using carbohydrate counting as the meal insulin dose strategy. 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. Pregnancy. 4. Severe hypoglycemic episode within 1 month of screening. 5. 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. 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®). Inhale 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). |
Country | Name | City | State |
---|---|---|---|
Canada | Institut de recherches cliniques de Montréal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherches Cliniques de Montreal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time below 4.0 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Mean glucose | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Percentage of time of glucose concentrations below 3.1 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Area under the curve of glucose values below 4.0 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Area under the curve of glucose values below 3.1 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Number of patients with at least one hypoglycemic event with or without symptoms | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Total number of hypoglycemic event below 3.1 mmol/L | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Total carbohydrate intake for hypoglycemia correction | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Total insulin delivery | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. | ||
Secondary | Total glucagon delivery | The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00. |
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