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Treatment of Hypoglycemia in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Induced-hypoglycemia test
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Hypoglycemia, carbohydrates

Eligibility Criteria

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

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
  4. 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. Known significant cardiac rhythm abnormality based on investigator judgment.
  4. Abnormal blood panel and/or anemia (Hb < 100g/L).
  5. Ongoing pregnancy or breastfeeding.
  6. Severe hypoglycemic episode within 1 month of screening.
  7. Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).

Sites / Locations

  • Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

16g of carbohydrates - Glucose levels < 3.0 mmol/L

16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L

32g of carbohydrates - Glucose levels < 3.0 mmol/L

32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L

Arm Description

Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are below 3.0 mmol/L.

Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.

Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are below 3.0 mmol/L

Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.

Outcomes

Primary Outcome Measures

Change in glucose levels 15 minutes after hypoglycemic treatment
Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

Secondary Outcome Measures

Change in glucose levels 20 minutes after hypoglycemic treatment
Change in glucose levels 20 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Change in glucose levels 30 minutes after hypoglycemic treatment
Change in glucose levels 30 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Change in glucose levels 45 minutes after hypoglycemic treatment
Change in glucose levels 45 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Change in glucose levels 60 minutes after hypoglycemic treatment
Change in glucose levels 60 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
Glucose levels 60 minutes after meal consumption
Glucose levels 90 minutes after meal consumption
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment

Full Information

First Posted
March 9, 2018
Last Updated
September 16, 2020
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT03489967
Brief Title
Treatment of Hypoglycemia in Type 1 Diabetes
Official Title
Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Hypoglycemia, carbohydrates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16g of carbohydrates - Glucose levels < 3.0 mmol/L
Arm Type
Active Comparator
Arm Description
Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are below 3.0 mmol/L.
Arm Title
16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L
Arm Type
Active Comparator
Arm Description
Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.
Arm Title
32g of carbohydrates - Glucose levels < 3.0 mmol/L
Arm Type
Active Comparator
Arm Description
Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are below 3.0 mmol/L
Arm Title
32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L
Arm Type
Active Comparator
Arm Description
Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.
Intervention Type
Other
Intervention Name(s)
Induced-hypoglycemia test
Intervention Description
Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given.
Primary Outcome Measure Information:
Title
Change in glucose levels 15 minutes after hypoglycemic treatment
Description
Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Time Frame
15 minutes after hypoglycemic treatment
Secondary Outcome Measure Information:
Title
Change in glucose levels 20 minutes after hypoglycemic treatment
Description
Change in glucose levels 20 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Time Frame
20 minutes after hypoglycemic treatment
Title
Change in glucose levels 30 minutes after hypoglycemic treatment
Description
Change in glucose levels 30 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Time Frame
30 minutes after hypoglycemic treatment
Title
Change in glucose levels 45 minutes after hypoglycemic treatment
Description
Change in glucose levels 45 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Time Frame
45 minutes after hypoglycemic treatment
Title
Change in glucose levels 60 minutes after hypoglycemic treatment
Description
Change in glucose levels 60 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Time Frame
60 minutes after hypoglycemic treatment
Title
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
Time Frame
60 minutes after hypoglycemia correction
Title
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
Time Frame
60 minutes after hypoglycemia correction
Title
Glucose levels 60 minutes after meal consumption
Time Frame
60 minutes after meal consumption
Title
Glucose levels 90 minutes after meal consumption
Time Frame
90 minutes after meal consumption
Title
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
Time Frame
10 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
Time Frame
15 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
Time Frame
20 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
Time Frame
25 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
Time Frame
30 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
Time Frame
35 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
Time Frame
10 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
Time Frame
15 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
Time Frame
20 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
Time Frame
25 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
Time Frame
30 minutes after hypoglycemic treatment
Title
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
Time Frame
35 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
Time Frame
10 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
Time Frame
15 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
Time Frame
20 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
Time Frame
25 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
Time Frame
30 minutes after hypoglycemic treatment
Title
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
Time Frame
35 minutes after hypoglycemic treatment
Title
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
Time Frame
40 minutes after the first hypoglycemic treatment
Title
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment
Time Frame
15 minutes after the first hypoglycemic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ≥ 18 years of old. Clinical diagnosis of type 1 diabetes for at least one year. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal). HbA1c ≤ 10%. 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. Known significant cardiac rhythm abnormality based on investigator judgment. Abnormal blood panel and/or anemia (Hb < 100g/L). Ongoing pregnancy or breastfeeding. Severe hypoglycemic episode within 1 month of screening. Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hypoglycemia in Type 1 Diabetes

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