Focus of the Report: This health technology assessment focuses on the use of t:slim X2 Insulin Pump and Dexcom 6 continuous glucose monitoring (CGM) with Control-IQ closed-loop control (CLC) or Basal-IQ predictive low-glucose suspend (PLGS) technology for the management of diabetes mellitus (DM).

Technology Description: Insulin pumps may be combined with CGM systems and control algorithms to optimize glycemic control in a way that resembles pancreatic function. The Tandem Diabetes Care t:slim X2 Insulin Pump can be integrated with the Dexcom G6 CGM system and 1 of 2 algorithms: Basal-IQ technology or Control-IQ technology.

Basal-IQ technology is a type of PLGS technology that uses Dexcom G6 CGM values to help reduce the frequency and duration of hypoglycemic events by predicting glucose levels 30 minutes ahead and suspending insulin if levels are expected to drop.

Control-IQ is a CLC technology (also known as an artificial pancreas) that helps to increase time in the target glycemic range by predicting glucose levels 30 minutes ahead and adjusting basal insulin delivery or bolus administration accordingly to prevent both hypoglycemia and hyperglycemia.

Controversy: Achieving glycemic control may be challenging for patients with type 1 DM. When insulin is required to control blood glucose levels, the options are either daily injections or use of an electronic pump and infusion set system. An artificial pancreas may have advantages over other diabetes management options; however, the suitability and potential disadvantages of these systems may require individual consideration.

Key Questions:

  • Is the t:slim X2 Insulin Pump effective in managing diabetes?

  • How does t:slim X2 Insulin Pump compare with clinical alternatives for diabetes?

  • Is the t:slim X2 Insulin Pump safe for managing diabetes?

  • Have definitive patient selection criteria been identified for the t:slim X2 Insulin Pump?

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