Type 1 Diabetes MellitusPICLSNCT03774186
Pregnancy Intervention With a Closed-Loop System (PICLS) Study
A study testing Hybrid closed-loop therapy and Sensor-augmented pump therapy in people with Type 1 Diabetes Mellitus and Pregnancy in Diabetes, run by University of Colorado, Denver at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes Mellitus, Pregnancy in Diabetes
- What is being tested?
- Hybrid closed-loop therapy and Sensor-augmented pump therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2019to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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
Who cannot join
- 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,
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado
Aurora, Colorado, 80045
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
This is a two-center, prospective, 'open-label', single-blind, investigator-initiated randomized controlled pilot study evaluating hybrid closed-loop (HCL) insulin delivery among pregnant women with T1D compared with sensor-augmented pump therapy (SAPT) throughout most of gestation and the first 6 weeks of the post-partum period at the Barbara Davis Center for Diabetes and Ohio State University.
Up to 37 women will be enrolled at ≤11 weeks gestation, sign informed consent, and begin a run-in phase. At baseline, the investigators will obtain data about demographics, health history, pregnancy history, and medication use. The investigators will conduct a physical exam, download diabetes devices already in use by subjects, obtain blood and urine tests, and administer validated questionnaires (Hypoglycemia Fear Survey, MOS Short-Form 36 [SF-26], INSPIRE Questionnaire, Insulin Delivery Satisfaction Survey [IDSS], and Glucose Monitoring Satisfaction Survey [GMSS]). During run-in, women will wear a CGM, fill out log sheets (glucose levels, insulin doses, carbohydrate intake, exercise), upload the CGM, and be in contact with research staff. Eligible subjects will then be trained on study devices for SAPT therapy. At the start of the 2nd trimester, women will be randomized to SAPT or HCL therapy.
During pregnancy, women will be seen at each institution monthly for vital signs, HbA1c measurements, device downloads, pump adjustments, medication use, reporting of adverse events and device-related deficiencies, and once a trimester the investigators will additionally obtain serum and urine measurements, specimens for the repository of biological specimens, and ask subjects to fill out questionnaires (Hypoglycemia Fear Survey, SF-35, IDSS, GMSS). Weekly remote contact will be obtained for pump adjustments and reporting of adverse events and device-related deficiencies. Women on HCL therapy will use SAPT during labor and delivery until 3-7 days post-partum, when a study clinician will put them back into auto mode (HCL therapy), if it is safe to do so. The final study visit will take place 4-6 weeks post-partum where the physical exam will be done, HbA1c obtained, device downloads obtained, and final questionnaires submitted (as above plus a post-partum survey). Medical records of the labor and delivery admission will be obtained.
- Conditions
- Type 1 Diabetes Mellitus, Pregnancy in Diabetes
- Being tested
- Hybrid closed-loop therapy, Sensor-augmented pump therapy
- Keywords
- type 1 diabetes mellitus, pregnancy, hybrid closed-loop therapy, artificial pancreas therapy, sensor-augmented pump therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid closed-loop therapyDevice
Also called artificial pancreas therapy
Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
Sensor-augmented pump therapyDevice
Also called SAPT
Insulin pump + non-communicating CGM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Hybrid closed-loop therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 9 months
Secondary outcomes (18)
Number of Episodes of Diabetic Ketoacidosis
Secondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period.
Measured: Through study completion, an average of 9 months
Number of Adverse Skin Reactions
Secondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: J-index
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control.
Formula: J-Index= 0.001 x (mean blood glucose level + SD)^2
The J-Index has not been validated in this population of Type 1 Diabetes pregnancies.
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar.
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar.
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average.
Measured: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints.
Measured: through study completion, an average of 9 months
Medical Outcomes Study (MOS) Short-Form 36 Score
Quality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Measured: through study completion, an average of 9 months
INSPIRE Questionnaire Score
Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Measured: through study completion, an average of 9 months
Insulin Delivery Satisfaction Survey (IDSS) Score
Device acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions.
Measured: through study completion, an average of 9 months
Glucose Monitoring Satisfaction Survey (GMSS) Score
Device acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions.
Measured: through study completion, an average of 9 months
Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia
Maternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Maternal Outcomes: Number of Participants With Cesarean Delivery
Maternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Maternal Outcomes: Average Gestational Weight Gain
Maternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth)
Fetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome
Fetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants
Fetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start21 Mar 2019
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Sarit Polsky, MD, MPH, Principal investigator, Regents of the University of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774186
- Sponsor's protocol ID
- 18-1798
- Acronym
- PICLS
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2018
- Last updated
- 28 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Intervention With a Closed-Loop System (PICLS) Study
- ClinicalTrials.gov ID
- NCT03774186
- Acronym / sponsor ID
- PICLS / 18-1798
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Ohio State University
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-center, prospective, 'open-label', single-blind, investigator-initiated randomized controlled pilot study evaluating hybrid closed-loop (HCL) insulin delivery among pregnant women with T1D compared with sensor-augmented pump therapy (SAPT) throughout most of gestation and the first 6 weeks of the post-partum period at the Barbara Davis Center for Diabetes and Ohio State University.
Up to 37 women will be enrolled at ≤11 weeks gestation, sign informed consent, and begin a run-in phase. At baseline, the investigators will obtain data about demographics, health history, pregnancy history, and medication use. The investigators will conduct a physical exam, download diabetes devices already in use by subjects, obtain blood and urine tests, and administer validated questionnaires (Hypoglycemia Fear Survey, MOS Short-Form 36 [SF-26], INSPIRE Questionnaire, Insulin Delivery Satisfaction Survey [IDSS], and Glucose Monitoring Satisfaction Survey [GMSS]). During run-in, women will wear a CGM, fill out log sheets (glucose levels, insulin doses, carbohydrate intake, exercise), upload the CGM, and be in contact with research staff. Eligible subjects will then be trained on study devices for SAPT therapy. At the start of the 2nd trimester, women will be randomized to SAPT or HCL therapy.
During pregnancy, women will be seen at each institution monthly for vital signs, HbA1c measurements, device downloads, pump adjustments, medication use, reporting of adverse events and device-related deficiencies, and once a trimester the investigators will additionally obtain serum and urine measurements, specimens for the repository of biological specimens, and ask subjects to fill out questionnaires (Hypoglycemia Fear Survey, SF-35, IDSS, GMSS). Weekly remote contact will be obtained for pump adjustments and reporting of adverse events and device-related deficiencies. Women on HCL therapy will use SAPT during labor and delivery until 3-7 days post-partum, when a study clinician will put them back into auto mode (HCL therapy), if it is safe to do so. The final study visit will take place 4-6 weeks post-partum where the physical exam will be done, HbA1c obtained, device downloads obtained, and final questionnaires submitted (as above plus a post-partum survey). Medical records of the labor and delivery admission will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sensor-augmented pump therapy (SAPT) | Active comparator | Device: Sensor-augmented pump therapyPregnant 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. |
| Hybrid closed-loop therapy (HCL) | Experimental | Device: Hybrid closed-loop therapyPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (18 listed)
- 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%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid closed-loop therapyAlso: artificial pancreas therapyHybrid closed-loop therapy with a proportional integral derivative (PID) algorithm | Device | Hybrid closed-loop therapy (HCL) |
| Sensor-augmented pump therapyAlso: SAPTInsulin pump + non-communicating CGM | Device | Sensor-augmented pump therapy (SAPT) |
Primary outcome
Number of Episodes of Severe Hypoglycemia
Time frame: through study completion, an average of 9 months
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
Time Spent With Glucose <54 mg/dL
Time frame: Through study completion, an average of 9 months
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
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Time frame: Through study completion, an average of 9 months
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
Fear of Hypoglycemia Score
Time frame: Through study completion, an average of 9 months
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
18 secondary outcomes
Number of Episodes of Diabetic Ketoacidosis
Time frame: Through study completion, an average of 9 months
Number of Adverse Skin Reactions
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: J-index
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: through study completion, an average of 9 months
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
Time frame: through study completion, an average of 9 months
Medical Outcomes Study (MOS) Short-Form 36 Score
Time frame: through study completion, an average of 9 months
INSPIRE Questionnaire Score
Time frame: through study completion, an average of 9 months
Insulin Delivery Satisfaction Survey (IDSS) Score
Time frame: through study completion, an average of 9 months
Glucose Monitoring Satisfaction Survey (GMSS) Score
Time frame: through study completion, an average of 9 months
Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia
Time frame: through study completion, an average of 9 months
Maternal Outcomes: Number of Participants With Cesarean Delivery
Time frame: through study completion, an average of 9 months
Maternal Outcomes: Average Gestational Weight Gain
Time frame: through study completion, an average of 9 months
Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth)
Time frame: through study completion, an average of 9 months
Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome
Time frame: through study completion, an average of 9 months
Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants
Time frame: through study completion, an average of 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarit Polsky, MD, MPH principal investigator
Regents of the University of Colorado
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid closed-loop therapy and Sensor-augmented pump therapy in people with Type 1 Diabetes Mellitus and Pregnancy in Diabetes, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Episodes of Severe Hypoglycemia (time frame: through study completion, an average of 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.