Condition or disease | Intervention/treatment | Phase |
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Type1 Diabetes Mellitus | Drug: empagliflozin Device: artificial pancreas | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of SGLT2 Inhibition on Improving the Glycemic Performance of the Single Hormone Artificial Pancreas Configuration in Type 1 Diabetes in the Outpatient Setting - A Randomized Placebo Controlled Cross-Over Multicentre Clinical Trial |
Actual Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | August 31, 2021 |
Estimated Study Completion Date : | August 31, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Empagliflozin arm
Participant will be treated by empagliflozin for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the placebo arm. Participant and research staff is blinded to arm assignment. |
Drug: empagliflozin
Treatment with empagliflozin 25mg orally once a day
Device: artificial pancreas Insulin delivery via a closed loop single-hormone artificial pancreas system.
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Placebo Comparator: Placebo arm
Participant will take placebo for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the empagliflozin arm. Participant and research staff is blinded to arm assignment. |
Device: artificial pancreas
Insulin delivery via a closed loop single-hormone artificial pancreas system.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrej Orszag | 416-586-4800 ext 7625 | class15@lunenfeld.ca | |
Contact: Nancy Cardinez, NP | 416-586-4800 ext 4436 | class15@lunenfeld.ca |
Canada, Ontario | |
Sinai Health System | Recruiting |
Toronto, Ontario, Canada, M5T 3L9 | |
Contact: Andrej Orszag 416-586-4800 class15@lunenfeld.ca | |
Principal Investigator: Bruce A. Perkins, MD | |
Canada, Quebec | |
McGill University | Not yet recruiting |
Montréal, Quebec, Canada, H3A 2B4 | |
Contact: Jennifer René, RN 418- 558-0742 | |
Principal Investigator: Ahmad Haidar |
Principal Investigator: | Bruce Perkins, MD | Samuel Lunenfeld Research Institute |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 13, 2019 | ||||||||
First Posted Date ICMJE | June 7, 2019 | ||||||||
Last Update Posted Date | November 6, 2019 | ||||||||
Actual Study Start Date ICMJE | August 1, 2019 | ||||||||
Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting | ||||||||
Official Title ICMJE | Effect of SGLT2 Inhibition on Improving the Glycemic Performance of the Single Hormone Artificial Pancreas Configuration in Type 1 Diabetes in the Outpatient Setting - A Randomized Placebo Controlled Cross-Over Multicentre Clinical Trial | ||||||||
Brief Summary | The most advanced configurations of the Artificial Pancreas (AP) have not yet been demonstrated to sufficiently maximize time in target glycemia. One limitation is the challenge of postprandial glycemic control, which currently requires ongoing patient engagement for accurate and detailed bolus dose estimation for meals. Sodium Glucose Linked Transporter 2 Inhibition (SGLT2i) provides an additional mechanism to attenuate post-prandial glycemic excursion, and may represent a strategy that could further alleviate carbohydrate counting burden and improve the performance of AP configurations. This trial aims to compare - using a randomized, masked placebo-controlled, crossover, multicenter design - the efficacy of the SGLT2i empagliflozin 25 mg oral per day each in the setting of single-hormone automated AP and conventional insulin pump therapy on the proportion of time spent in target and in hypoglycemia each during a 4-week day-and-night period. The pilot trial aims to enroll 28 adult patients with type 1 diabetes (T1D) across 2 research sites (one in Toronto and one in Montreal) and includes a 2- week therapy optimization run-in period, 4-weeks for each of the two AP intervention arms, and a 1- week washout in between the pharmacological intervention sequences. Glucose levels will be measured by continuous glucose monitoring (G5, Dexcom Inc.). Insulin will be infused using a subcutaneous infusion pump (t-slim, Tandem Diabetes Care) and communication between pumps and the algorithm will be implemented using Android Smartphone devices and Bluetooth technology communication. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Type1 Diabetes Mellitus | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
28 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 31, 2021 | ||||||||
Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03979352 | ||||||||
Other Study ID Numbers ICMJE | CLASS 17 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||||||
Study Sponsor ICMJE | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||||||
Collaborators ICMJE | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||||||||
Investigators ICMJE |
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PRS Account | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||||||
Verification Date | November 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |