Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices (CLIMB)

Closed-Loop Insulin Delivery Postpartum in Mothers With Type 1 Diabetes and Their Babies' Feeding Practices

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Feeding Behavior; Infant Development; Diabetes Mellitus Type 1 Pre-Existing
• Intervention / Treatment: Combination product: Early auto-mode; Combination product: Delayed auto mode

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • University of Calgary
  • Ontario
    • Toronto, Ontario, Canada, M5T 3L9
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18 to 45, with at least a two year duration of type 1 diabetes, on intensive insulin therapy (at least 3 daily insulin injections or insulin pump) with a Hba1c during pregnancy < 9.9 % at study entry who are confirmed by ultrasound, to have a viable singleton pregnancy between 12 and 32 weeks gestation and are not planning to conceive another pregnancy in the first 24 weeks postpartum.

Exclusion Criteria:

• Non-type 1 diabetes
• Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results
• Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
• Known or suspected allergy against insulin.
• Women with advanced nephropathy (eGFR<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results.
• Total daily insulin dose of less than 8 or greater than 250 units/day.
• Severe visual or hearing impairment
• Unable to speak and understand English (or French)
• Planning to conceive another pregnancy within the first six months postpartum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early auto-mode enabled; Auto mode continuous glucose monitoring enabled 2-10 days post-partum	Combination product: Early 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.
Active Comparator: Delayed auto mode enabled; Auto mode continuous glucose monitoring enabled 12 weeks post-partum	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Auto vs. Manual Mode of MiniMed 670G on Time in Target Range Assessed via CGM	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode result in more time in target range (3.9 to 10 mmol/L) assessed by CGM?	12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Auto vs. Manual Mode of MiniMed 670G on Time Spent Below Target Range Assessed via CGM	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode result in less time spent below target range assessed by CGM (≥15 minutes with CGM glucose <3.9 mmol/L [level 1], 2.8 mmol/L [level 2] assessed by CGM?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Time Spent Above Target Range Assessed via CGM	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode result in less time above target range > 10 mmol/L assessed by CGM?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Glycemic Variability Assessed via CGM	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode result in less glycemic variability assessed by CGM?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Diabetes Self-Care Assessed via Diabetes Distress Scale 3	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact the burden of diabetes self-care, assessed by the Diabetes Distress Scale 3?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Quality of Life Assessed via Diabetes Distress Scale 3 and the Hypoglycemia Fear Survey Questionnaire II	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact the quality of life, assessed by the Diabetes Distress Scale 3 and the Hypoglycemia Fear Survey Questionnaire II?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Sleep Assessed via Pittsburgh Sleep Quality Index	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact sleep, assessed by the Pittsburgh Sleep Quality Index (PSQI)? In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	12 weeks postpartum
Assess Acceptability of Auto-mode MiniMed 670G via qualitative interviews.	In postpartum women, with type 1 diabetes is use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode, acceptable to patients, their partners and their care providers, assessed via qualitative interviews.	24 weeks postpartum
Assess Feasibility of Auto-mode MiniMed 670G via study recruitment, retention and completion rates.	In postpartum women, with type 1 diabetes is use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode, feasibleto patients, their partners and their care providers, assessed by the recruitment, retention and completion rates for this study?	24 weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Auto vs. Manual Mode of MiniMed 670G on Infant Feeding Practices Assessed via Child Food and Liquid Intake Questionnaire	In postpartum women, with type 1 diabetes does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact infant feeding practices? This will be assessed by the Child Food and Liquid Intake questionnaire. There is a 3 point scale for questions about child food and liquid intake. There is a 7 point scale for questions about the frequency of breast milk and other liquids in foods.	12 weeks postpartum
Impact of Weaning on Total Daily Insulin Requirement on Women who Discontinue Lactation	Among study women that discontinue lactation during the study period what is the impact of weaning on total daily insulin requirements weekly average in the two weeks prior to commencing weaning compared to the two weeks after weaning completed?	24 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Sugar Concentrations in Breast Milk Assessed by Liquid Chromatography	In postpartum women with type 1 diabetes, does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact sugars (fructose, glucose and lactose) concentration of breast milk. This will be assessed by liquid chromatography-mass spectrometry on expressed breast milk samples.	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Breast Milk Consumption Assessed by Difference in Infant Weight	In postpartum women with type 1 diabetes, does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact volume of breast milk consumed, assessed by the difference in grams of baby weight before and after feeding as measured on an infant weight scale?	12 weeks postpartum
Effect of Auto vs. Manual Mode of MiniMed 670G on Infant Weight, Assessed by Weight Measurements	1d.) In postpartum women with type 1 diabetes, does use of the MiniMed 670G hybrid closed-loop system, enabled with auto mode compared with the MiniMed 670G in manual mode impact infant weight? This will be assessed by measurements taken at time of study followup visits.	12 weeks postpartum.
Impact of Weaning on Total Daily Insulin Requirement Assessed by Child Food and Liquid Intake Questionnaire	Among study women that discontinue lactation during the study period what is the impact of weaning on total daily insulin requirements weekly average in the two weeks prior to commencing weaning compared to the two weeks after weaning completed, assessed by the Child Food and Liquid Intake questionnaire?	24 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Medtronic; Ward of the 21st Century; Calgary Health Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 10027445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No