NCT03761615: LOIS-P

Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

Completed Results posted Last updated 12 April 2024

What this trial tests

trial testing Dexcom G6 CGM in Type 1 Diabetes Mellitus in 25 participants. Completed in 9 June 2021.

Timeline

13 November 2018

Primary endpoint
9 June 2021

9 June 2021

Quick facts

Lead sponsor	Sansum Diabetes Research Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	25
Start date	13 November 2018
Primary completion	9 June 2021
Estimated completion	9 June 2021
Sites	3 locations across United States

Drugs / interventions tested

• Dexcom G6 CGM

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
• Pregnancy in Diabetics — all drugs for Pregnancy in Diabetics →

Sponsor

Sansum Diabetes Research Institute

Who can join

Adults 18 to 40, female only, with Type 1 Diabetes Mellitus or Pregnancy in Diabetics. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM Primary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time in range defined as 63-140 mg/dL as determined by CGM analysis

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	59	± 14

Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time spent below target cgm glucose range defined as glucose \<63 mg/dL

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	3	± 3

Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time spent above target cgm glucose range defined as \>140 mg/dL

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	38	± 15

Episodes of Clinically Significant Hyperglycemia Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Episodes of clinically significant hyperglycemia with CGM glucose \>180 mg/dL

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.08	± 0.28

Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester Secondary · 2 weeks

Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.88	± 0.04

Basal Insulin Requirements Over Last 2 Weeks of Third Trimester Secondary · 2 weeks

Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.4	± 0.03

Carbohydrate Consumption Over Last 2 Weeks of Third Trimester Secondary · 2 weeks

Carbohydrate consumption (g/(kg\*day)) over last 2 weeks of third trimester

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	1.76	± 0.11

Ketoacidosis Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Episodes of ketoacidosis requiring emergency room or hospital admission

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.0	± 0.0

Maternal Complications Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.36	± 0.49

Gestational Weight Gain Secondary · Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Gestational weight gain each week

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	0.42	± 0.14

Gestational Age at Delivery Secondary · Immediately at birth

Gestational age at delivery (Weeks)

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	37.7	± 1.6

Birth Weight of Baby Secondary · Immediately at birth

Birth weight of baby (kg)

Group	Value	95% CI
Type 1 Diabetes and Pregnancy	3700	2135 – 4345

Adverse events — posted to ClinicalTrials.gov

Time frame: During pregnancy, up to 39 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Type 1 Diabetes and Pregnancy

Serious: 2/25 (8%)

Deaths: 0/25

Serious adverse events (1 terms)

Reaction	System	Type 1 Diabetes and Pregna…
Severe Hypoglycemia	Endocrine disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Type 1 Diabetes and Pregna…
Preeclampsia	Pregnancy, puerperium and perinatal conditions	—
gestational hypertension	Pregnancy, puerperium and perinatal conditions	—
Polyhydramnios	Pregnancy, puerperium and perinatal conditions	—

Most-reported serious reactions: Severe Hypoglycemia.

Data from ClinicalTrials.gov NCT03761615 adverse events section.

Sponsor's own description

The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose \<63 mg/dL.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Longitudinal Observation of Insulin Use and Glucose Sensor Metrics in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitors and Insulin Pumps: The LOIS-P Study.
   O'Malley G, Ozaslan B, Levy CJ, Castorino K, et al · · 2021 · cited 27× · PMID 34270347 · DOI 10.1089/dia.2021.0112