Pregnancy Intervention With a Closed-Loop System (PICLS) Study

NCT03774186 | Completed Results DMC FDA Device

• 1 other identifier: 18-1798
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim \[SA\] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (\<63, 63-140, \>140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.

Conditions

Type 1 Diabetes Mellitus; Pregnancy in Diabetes

Keywords

type 1 diabetes mellitus; pregnancy; hybrid closed-loop therapy; artificial pancreas therapy; sensor-augmented pump therapy

Outcome Measures

Primary Outcomes (4)

• Number of Episodes of Severe Hypoglycemia

  Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance

  through study completion, an average of 9 months

• Time Spent With Glucose <54 mg/dL

  Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose \<54 mg/dL

  Through study completion, an average of 9 months

• Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring

  Indices of glucose control are time spent in the glucose target ranges \<54 mg/dL and \<63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and \>140 mg/dL and \>180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum

  Through study completion, an average of 9 months

• Fear of Hypoglycemia Score

  Fear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery

  Through study completion, an average of 9 months

Secondary Outcomes (18)

• Number of Episodes of Diabetic Ketoacidosis

  Through study completion, an average of 9 months

• Number of Adverse Skin Reactions

  through study completion, an average of 9 months

• Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation

  through study completion, an average of 9 months

• Secondary Indices of Glucose Control: J-index

  through study completion, an average of 9 months

• Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)

  through study completion, an average of 9 months

Study Arms (2)

Sensor-augmented pump therapy (SAPT)

ACTIVE COMPARATOR

Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.

Device: Sensor-augmented pump therapy

Hybrid closed-loop therapy (HCL)

EXPERIMENTAL

Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.

Device: Hybrid closed-loop therapy

Interventions

Hybrid closed-loop therapy DEVICE

Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm

Also known as: artificial pancreas therapy

Hybrid closed-loop therapy (HCL)

Sensor-augmented pump therapy DEVICE

Insulin pump + non-communicating CGM

Also known as: SAPT

Sensor-augmented pump therapy (SAPT)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with T1D,
• pregnant within the first 11 weeks of gestation,
• years of age or older,
• diabetes duration \>1 year,
• using MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) therapy,
• willingness to routinely check at least 3-7 blood glucose measurements per day,
• ability and willingness to receive routine and specialty obstetric care throughout the course of the study,
• ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy and early post-partum period,
• A1C 5.5 - 9%,
• willing to participate in the run-in phase and full study (if eligible), and
• able to speak, read, and write English

You may not qualify if:

• women with T2D, gestational diabetes, or other type of diabetes (e.g., MODY), - -
• pregnancy beyond gestational week 11 or higher,
• age \<18 years,
• T1D duration \<1 year,
• screening A1C \<5.5% or \>9%,
• use of basal insulin alone,
• use of bolus insulin alone,
• extensive skin changes/diseases that inhibit wearing an infusion set, insulin pod, or sensor on normal skin,
• known severe allergic reaction to device adhesives within the last 3 months,
• unwillingness to use an insulin pump with tubing,
• unwillingness to be randomized to study group,
• unwillingness to switch from MDI to CSII and CGM (continuous glucose monitor) use (if applicable),
• unwillingness to switch from MDI or to change from current insulin pump to HCL system (if applicable),
• severe hypoglycemic episode requiring the assistance of a 3rd party within the last 6 months,
• non-compliance with run-in phase,

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Juvenile Diabetes Research Foundation: collaborator
• Ohio State University: collaborator

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Sarit Polsky
• Organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus

sarit.polsky@cuanschutz.edu

303-724-8575

Study Officials

• Sarit Polsky, MD, MPH

  Regents of the University of Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biostatistician is blinded to intervention assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 12, 2018
• Study Start: March 21, 2019
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)