Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices
Condition: Diabetes Mellitus Type 1 Pre-Existing; Pregnancy Related; Feeding Behavior; Infant Development
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will is a parallel two-group randomized controlled trial that will use the MiniMed
      670G hybrid closed-loop system's continuous glucose monitor (GCM) insulin pump and computer
      algorithm to deliver insulin when in "auto mode". This study will be conducted in women with
      type 1 diabetes after delivery of their neonate to see if "auto-mode" improves blood sugar
      control, episodes of low blood sugar, burden of diabetes self-care, alters baby's weight and
      feeding patterns, and partner diabetes distress.
    

Detailed description: 
      Women work very hard prior during pregnancy to try to control their blood sugars. However,
      after delivery, women often feel they need a rest from the intense effort they have put into
      diabetes self-care during pregnancy due to the demands of caring for a newborn,
      breastfeeding, and sleep deprivation. Attention to blood sugar control after delivery remains
      important because these new factors a may increase the risk of nighttime low blood sugar and
      unrecognized low blood sugar. Blood sugar has been shown to influence the sugar levels in
      breastmilk. How this affects the child has not been well study.

      The MiniMed 670G hybrid closed-loop system uses a continuous glucose monitor (GCM) insulin
      pump and computer algorithm to deliver insulin when in "auto mode". The system uses input
      about the individual's glucose values obtained from the continuous glucose sensor (CGM) to
      adjust the amount of insulin that is needed between meals and overnight.

      Manual mode of the insulin pump delivers insulin based on preprogrammed insulin delivery
      settings on the insulin pump regardless of the person's glucose levels.

      This is a randomized controlled pilot trial followed by an observational cohort study in
      postpartum women with type 1 diabetes, of the MiniMed 670G hybrid closed-loop insulin
      delivery system with early 6 to 10 days postpartum) versus delayed (12 weeks postpartum) auto
      mode enabled MiniMed 670G hybrid closed-loop insulin delivery system. This study will assess
      the impact of auto mode enabled hybrid closed-loop on glycemic control, occurrence of
      maternal hypoglycemia, and burden of diabetes self-care, infant weight and feeding practices.
      The investigators will also assess the acceptability of the auto mode enabled MiniMed 670G
      during lactation and postpartum and the feasibility of conducting a larger multicentre trial.
    

Intervention name(s): Early auto-mode; Delayed auto mode
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.; Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment