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出境医 / 临床实验 / Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Study Description
Brief Summary:
The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Combination Product: Fiasp+Pramlintide Closed-Loop System Device: Fiasp Closed-Loop System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

This study is a randomized, 2-way, crossover trial assessing:

i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : August 6, 2019
Actual Study Completion Date : August 6, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Simple Meal Announcement
Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.
 Combination Product: Fiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Active Comparator: Full Carbohydrate counting
The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus.
 Device: Fiasp Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin alone
Outcome Measures
Primary Outcome Measures :
  1. Time in target [ Time Frame: 24 hours ]
    Time spent in target range (between 4.0 mmol/L and 10 mmol/L)

  2. Time in hypoglycemia [ Time Frame: 24 hours ]
    Time spent in hypoglycemic range (below 4.0 mmol/L)

  3. Time in hyperglycemia [ Time Frame: 24 hours ]
    Time spent in hyperglycemic range (above 10.0 mmol/L)


Other Outcome Measures:
  1. Hypoglycemia treatment [ Time Frame: 24 hrs ]
    Number of participants experiencing hypoglycemia requiring oral treatment

  2. Hypoglycemia treatment [ Time Frame: During the night of the 24 hour intervention (11pm-7am) ]
    Number of participants experiencing hypoglycemia requiring oral treatment

  3. Hypoglycemia treatment [ Time Frame: During the day of the 24 hour intervention (7am-11pm) ]
    Number of participants experiencing hypoglycemia requiring oral treatment

  4. Gastrointestinal symptoms [ Time Frame: 24 hours ]
    Presence of gastrointestinal symptoms


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥ 12 years of age.
  2. Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
  3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  4. Insulin pump therapy for at least 6 months.
  5. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).
  2. Current use of glucocorticoid medication.
  3. Use of medication that alters gastrointestinal motility.
  4. Planned or ongoing pregnancy.
  5. Breastfeeding individuals.
  6. Severe hypoglycemic episode within one month of admission.
  7. Severe diabetes keto-acidosis episode within one month of admission.
  8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  10. Known hypersensitivity to any of the study drugs or their excipients.
  11. Individuals with hypoglycemia unawareness.
  12. Individuals with confirmed gastroparesis.
  13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Study Discontinuation/Withdrawal

  1. Failure to comply with the protocol.
  2. Pregnancy.
  3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
Contacts and Locations

Locations
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Canada, Quebec
McGill University Health Center
Montréal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University
Juvenile Diabetes Research Foundation
Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date August 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Time in target [ Time Frame: 24 hours ]
    Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
  • Time in hypoglycemia [ Time Frame: 24 hours ]
    Time spent in hypoglycemic range (below 4.0 mmol/L)
  • Time in hyperglycemia [ Time Frame: 24 hours ]
    Time spent in hyperglycemic range (above 10.0 mmol/L)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2019)
  • Hypoglycemia treatment [ Time Frame: 24 hrs ]
    Number of participants experiencing hypoglycemia requiring oral treatment
  • Hypoglycemia treatment [ Time Frame: During the night of the 24 hour intervention (11pm-7am) ]
    Number of participants experiencing hypoglycemia requiring oral treatment
  • Hypoglycemia treatment [ Time Frame: During the day of the 24 hour intervention (7am-11pm) ]
    Number of participants experiencing hypoglycemia requiring oral treatment
  • Gastrointestinal symptoms [ Time Frame: 24 hours ]
    Presence of gastrointestinal symptoms
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement
Official Title  ICMJE A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
Brief Summary The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

This study is a randomized, 2-way, crossover trial assessing:

i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Combination Product: Fiasp+Pramlintide Closed-Loop System
    Closed-loop insulin delivery with Fiasp insulin and pramlintide
  • Device: Fiasp Closed-Loop System
    Closed-loop insulin delivery with Fiasp insulin alone
Study Arms  ICMJE
  • Experimental: Simple Meal Announcement
    Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.
    Intervention: Combination Product: Fiasp+Pramlintide Closed-Loop System
  • Active Comparator: Full Carbohydrate counting
    The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus.
    Intervention: Device: Fiasp Closed-Loop System
Publications * Tsoukas MA, Cohen E, Legault L, von Oettingen JE, Yale JF, Vallis M, Odabassian M, El Fathi A, Rutkowski J, Jafar A, Ghanbari M, Gouchie-Provencher N, René J, Palisaitis E, Haidar A. Alleviating Carbohydrate Counting with a FiASP-plus-Pramlintide Closed-Loop Delivery System (Artificial Pancreas): Feasibility and Pilot Studies. Diabetes Obes Metab. 2021 May 28. doi: 10.1111/dom.14447. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2019) 		8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 6, 2019
Actual Primary Completion Date August 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females ≥ 12 years of age.
  2. Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
  3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  4. Insulin pump therapy for at least 6 months.
  5. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).
  2. Current use of glucocorticoid medication.
  3. Use of medication that alters gastrointestinal motility.
  4. Planned or ongoing pregnancy.
  5. Breastfeeding individuals.
  6. Severe hypoglycemic episode within one month of admission.
  7. Severe diabetes keto-acidosis episode within one month of admission.
  8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  10. Known hypersensitivity to any of the study drugs or their excipients.
  11. Individuals with hypoglycemia unawareness.
  12. Individuals with confirmed gastroparesis.
  13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Study Discontinuation/Withdrawal

  1. Failure to comply with the protocol.
  2. Pregnancy.
  3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993366
Other Study ID Numbers  ICMJE 2019-4947
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party McGill University
Study Sponsor  ICMJE McGill University
Collaborators  ICMJE Juvenile Diabetes Research Foundation
Investigators  ICMJE Not Provided
PRS Account McGill University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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