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Sleep Duration in Women With Previous Gestational Diabetes

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University of Illinois

Status

Completed

Conditions

Gestational Diabetes

Treatments

Behavioral: Healthy living
Behavioral: Sleep extension

Study type

Interventional

Funder types

Other

Identifiers

NCT03638102
2018-0992

Details and patient eligibility

About

Women with a history of gestational diabetes (GDM) are at high risk of developing diabetes in the future. Sleep disturbances are emerging as risk factors for incident diabetes. The purpose of this study is to test the effects of 6-week sleep extension in women with a history of GDM and short sleep on glucose metabolism by randomized controlled study.

Full description

The primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of GDM and habitual short sleep duration on the outcomes of glucose metabolism. The participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. Glucose metabolism parameters will be assessed by an oral glucose tolerant test.

Enrollment

18 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes
  • At least one year post-partum
  • Reported habitual sleep duration <7h/night during work- or weekdays with a desire to sleep longer
  • Reported time spent in bed =<8 hours
  • Own a smartphone compatible with Fitbit.
  • No need to provide care at night for her child(ren), defined as >3 times a week and >30 minutes at a time
  • No history of obstructive sleep apnea, insomnia, or restless leg syndrome

Exclusion criteria

  • A1C ≥6.5%
  • Currently pregnant or planning pregnancy or breast feeding
  • Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15)
  • Rotating shift or night shift work
  • High risk for obstructive sleep apnea screened by STOP BANG questionnaire.
  • Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups

Sleep intervention
Experimental group
Description:
Sleep extension
Treatment:
Behavioral: Sleep extension
Healthy living
Active Comparator group
Description:
Health education
Treatment:
Behavioral: Healthy living

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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