Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes

NCT04876079 | Completed

• 1 other identifier: 2022-1119
• Study Type: interventional
• Target: 30
• 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. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).

Conditions

Type 1 Diabetes

Keywords

Hypoglycemia; Type 1 diabetes; Carbohydrates

Outcome Measures

Primary Outcomes (1)

• Time spent of glucose levels < 4.0 mmol/L

  60 minutes after carbohydrates consumption

Secondary Outcomes (27)

• Plasma glucose levels at 5 minutes after carbohydrates consumption

  5 minutes after carbohydrates consumption

• Plasma glucose levels at 10 minutes after carbohydrates consumption

  10 minutes after carbohydrates consumption

• Plasma glucose levels at 15 minutes after carbohydrates consumption

  15 minutes after carbohydrates consumption

• Plasma glucose levels at 20 minutes after carbohydrates consumption

  20 minutes after carbohydrates consumption

• Plasma glucose levels at 30 minutes after carbohydrates consumption

  30 minutes after carbohydrates consumption

Study Arms (3)

16g of carbohydrates - Plasma glucose < 4.0 mmol/L

ACTIVE COMPARATOR

16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)

Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin

16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L

ACTIVE COMPARATOR

16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.

Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin

16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L

ACTIVE COMPARATOR

16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.

Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin

Interventions

Dexcom G6 DEVICE

Participants will have to wear a Dexcom G6 during study interventions

16g of carbohydrates - Plasma glucose < 4.0 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L

Dex4 OTHER

When the glycemic threshold is reach, participants will be given 16g of Dex4

16g of carbohydrates - Plasma glucose < 4.0 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L

Insulin DRUG

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

16g of carbohydrates - Plasma glucose < 4.0 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L

Test to induce a decline in plasma glucose 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 bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.

16g of carbohydrates - Plasma glucose < 4.0 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L; 16g of carbohydrates - Plasma glucose ≤ 5.0 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 old
• Clinical diagnosis of type 1 diabetes for at least one year
• Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
• A glycated hemoglobin A1c ≤ 10%

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (eGFR \< 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
• Recent (\< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
• Known significant cardiac rhythm abnormality based on investigator's judgement
• Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
• Ongoing pregnancy or breastfeeding
• Severe hypoglycemia episode within 1 month of screening
• Known uncorrected hypokalemia within the past 3 months (potassium \< 3.5 mmol/L)

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Montreal Clinical Research Institute

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Glucose; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rémi 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: May 3, 2021
• First Posted: May 6, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)