N/A
N=24
Pregnancy Intervention With a Closed-Loop System (PICLS) Study
Type 1 Diabetes Mellitus · Pregnancy in Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03774186 ↗Enrolled (actual)
24
Serious AEs
25.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Episodes of Severe Hypoglycemia — 0; 0 Number of Episodes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hybrid closed-loop therapy (Device); Sensor-augmented pump therapy (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Episodes of Severe Hypoglycemia |
0; 0 | — |
| PRIMARY Time Spent With Glucose <54 mg/dL |
3.98; 4.04; 2.84; 1.68; 2.01; 1.23 | — |
| PRIMARY Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring |
3.98; 4.04; 2.84; 1.68; 2.01; 1.23 | — |
| PRIMARY Fear of Hypoglycemia Score |
69.4; 69.0; 69.0; 60.5; 67.3; 64.7 | — |
| SECONDARY Number of Episodes of Diabetic Ketoacidosis |
0; 1 | — |
| SECONDARY Number of Adverse Skin Reactions |
5; 1 | — |
| SECONDARY Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation |
122; 125; 126; 137; 120; 132 | — |
| SECONDARY Secondary Indices of Glucose Control: J-index |
26.2; 29.5; 29.3; 32.0; 29.5; 34.6 | — |
| SECONDARY Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) |
4.54; 5.32; 5.23; 6.12; 4.78; 5.61 | — |
| SECONDARY Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) |
5.48; 5.67; 5.40; 5.92; 4.83; 4.09 | — |
| SECONDARY Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) |
84.4; 98.8; 91.9; 100.9; 85.4; 94.5 | — |
| SECONDARY Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) |
39.9; 42.0; 41.3; 44.3; 36.4; 40.1 | — |
| SECONDARY Medical Outcomes Study (MOS) Short-Form 36 Score |
73.96; 82.23; 76.30; 85.72; 66.01; 77.09 | — |
| SECONDARY INSPIRE Questionnaire Score |
73.6; 79.3; 76.2; 76.5 | — |
| SECONDARY Insulin Delivery Satisfaction Survey (IDSS) Score |
4.00; 4.06; 3.80; 4.19; 3.85; 3.92 | — |
| SECONDARY Glucose Monitoring Satisfaction Survey (GMSS) Score |
4.07; 3.83; 3.65; 4.06; 3.66; 3.89 | — |
| SECONDARY Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia |
4; 4 | — |
| SECONDARY Maternal Outcomes: Number of Participants With Cesarean Delivery |
10; 7 | — |
| SECONDARY Maternal Outcomes: Average Gestational Weight Gain |
14.1; 11.5 | — |
| SECONDARY Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) |
0; 0 | — |
| SECONDARY Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome |
6; 6 | — |
| SECONDARY Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants |
4; 5 | — |
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 ( 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.
Eligibility Criteria
Inclusion Criteria
- women with T1D,
- pregnant within the first 11 weeks of gestation,
- 18 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
Exclusion Criteria
- women with T2D, gestational diabetes, or other type of diabetes (e.g., MODY), - -
- pregnancy beyond gestational week 11 or higher,
- age 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,
- inadequate access to a phone and computer (for downloading devices and web-based communications),
- intention to move out of state within the next year, and
- any other condition determined by the PI which could make the subject unsuitable for the trial or impairs the validity of the informed consent
Data sourced from ClinicalTrials.gov (NCT03774186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.