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Trial record 18 of 49 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

Insulin-based Strategies to Prevent Hypoglycemia During Exercise

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ClinicalTrials.gov Identifier: NCT02631265
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:
It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Exercise 1 Other: Exercise 2 Other: Exercise 3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Study Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Reduction of insulin basal rate at the time of exercise Other: Exercise 1
Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Active Comparator: Reduction of insulin basal rate 20 minutes prior to exercise Other: Exercise 2
Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Active Comparator: Reduction of insulin basal rate 40 minutes prior to exercise Other: Exercise 3
Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).




Primary Outcome Measures :
  1. Percentage of time of capillary blood glucose levels spent below 4 mmol/L [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15


Secondary Outcome Measures :
  1. Decrease in glucose levels [ Time Frame: This outcome will be measured over 45 minutes. ]
    Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until the end of exercise. This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  2. Decremental area under the curve of sensor glucose levels [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  3. Area under the curve of sensor glucose levels < 4 mmol/L [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  4. Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  5. Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  6. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  7. Total number of hypoglycemia episode requiring treatment [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  8. Percentage of time spent between 4 and 10 mmol/L [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  9. Mean time (minutes) to the first hypoglycemic event [ Time Frame: This outcome will be measured over 45 minutes. ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  10. Percentage of time spent < 4.0 mmol/L [ Time Frame: This outcome will be measured over 14.75 hours. ]
    This time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.

  11. Percentage of time of sensor glucose levels spent below 4 mmol/L [ Time Frame: This outcome will be measure over 45 minutes ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  12. Absolute difference between capillary blood glucose levels and sensor glucose levels [ Time Frame: This outcome will be measure over 45 minutes ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  13. Relative difference between capillary blood glucose levels and sensor glucose levels [ Time Frame: This outcome will be measure over 45 minutes ]
    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥ 18 years of 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.
  4. Last (less than 2 months) HbA1c ≤ 12%.

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. Abnormal blood panel and/or anemia.
  4. Ongoing pregnancy.
  5. Severe hypoglycemic episode within two weeks of screening.
  6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  7. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631265


Locations
Canada, Quebec
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
Principal Investigator: Rémi Rabasa-Lhoret Institut de recherches cliniques de Montréal

Responsible Party: Rémi Rabasa-Lhoret, Professor of medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT02631265     History of Changes
Other Study ID Numbers: RIDE-1
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Type 1 diabetes
Exercise
Hypoglycemia
Insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Hypoglycemia
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs