Treatment of Hypoglycemia in Type 1 Diabetes

NCT03489967 | Completed

• 1 other identifier: HYPO-T
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Hypoglycemia, carbohydrates

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes after hypoglycemic treatment

Secondary Outcomes (28)

• Change in glucose levels 20 minutes after hypoglycemic treatment

  20 minutes after hypoglycemic treatment

• Change in glucose levels 30 minutes after hypoglycemic treatment

  30 minutes after hypoglycemic treatment

• Change in glucose levels 45 minutes after hypoglycemic treatment

  45 minutes after hypoglycemic treatment

• Change in glucose levels 60 minutes after hypoglycemic treatment

  60 minutes after hypoglycemic treatment

• Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction

  60 minutes after hypoglycemia correction

Study Arms (4)

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

ACTIVE COMPARATOR

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

Other: Induced-hypoglycemia test

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

ACTIVE COMPARATOR

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

Other: Induced-hypoglycemia test

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

ACTIVE COMPARATOR

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

Other: Induced-hypoglycemia test

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

ACTIVE COMPARATOR

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

Other: Induced-hypoglycemia test

Interventions

Induced-hypoglycemia test OTHER

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.

16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L; 16g of carbohydrates - Glucose levels < 3.0 mmol/L; 32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L; 32g of carbohydrates - Glucose levels < 3.0 mmol/L

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.
• Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
• HbA1c ≤ 10%.

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.
• 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).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Canada

Location

Related Publications (1)

• Taleb N, Gingras V, Cheng R, Parent V, Messier V, Bovan D, Shohoudi A, Brazeau AS, Rabasa-Lhoret R. Non-severe hypoglycemia in type 1 diabetes: a randomized crossover trial comparing two quantities of oral carbohydrates at different insulin-induced hypoglycemia ranges. Front Endocrinol (Lausanne). 2023 Jun 2;14:1186680. doi: 10.3389/fendo.2023.1186680. eCollection 2023.

  PMID: 37334295 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 6, 2018
• Study Start: April 18, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

CA (1)