Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Study ID
NCT03979352
Phase
PHASE3
Status
Completed

Conditions

  • Type1 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • empagliflozin — DRUG
    Treatment with empagliflozin 25mg orally once a day
  • artificial pancreas — DEVICE
    Insulin delivery via a closed loop single-hormone artificial pancreas system.

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Nov 2019
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo [ Time Frame: 20 weeks ]

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