NCT03064321

Brief Summary

This study will test the effect of the an insomnia intervention with cognitive behavioral treatment delivered via web compared with an information control group on glucose control and self management behavioral in a sample of persons with type 2 diabetes (T2DM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

February 15, 2017

Last Update Submit

February 9, 2021

Conditions

InsomniaDiabetes Mellitus, Type 2

Keywords

cognitive behavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Average Glucose Control for Last 3 Months Assessed by A!C level

    A1C level

    After 12 weeks of either the insomnia intervention or the information control intervention

Secondary Outcomes (1)

  • Sleep Quality

    After 12 weeks of either the insomnia intervention or the information control intervention

Other Outcomes (1)

  • Insomnia Severity

    After 12 weeks of either the insomnia intervention or the information control intervention

Study Arms (2)

Insomnia Intervention

EXPERIMENTAL

Insomnia intervention delivered via web using Cognitive Behavior Treatment

Behavioral: Insomnia Intervention

Information Control

OTHER

General health information website

Other: Information Control

Interventions

Insomnia InterventionBEHAVIORAL

The SHUTi intervention is based on a cognitive behavioral treatment for insomnia (CBT-I) and organized into six structured, weekly online sessions. Each week the participants will complete a 30-minute interactive learning module and to complete daily online sleep diaries will be used.

Insomnia Intervention
Information ControlOTHER

Information on websites that are general health promoting

Information Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) T2DM with suboptimal glucose control
  • (2) age 18 years or older;
  • (3) willing to be randomized to SHUTi or IC group;
  • (4) able to speak, read, and write in English, and
  • (5) insomnia symptoms with at least one daytime consequence \[e.g. impaired mood, poor sleep quality, excessive daytime sleepiness, fatigue\].

You may not qualify if:

  • Type 1 or gestational diabetes
  • Change in oral medications or \> 10% change in insulin in last 3 months
  • Acute medical or psychiatric illness or hospitalization ≤ 3 months (such as angina, stroke, major surgery, major depression or serious psychiatric conditions)
  • AHI (apnea-hypopnea index; apnea \[cessation of breathing\] or hypopnea \[reduction in breathing\]) ≥ 10 episodes an hour on overnight sleep study
  • Non-ambulatory
  • Self-reported epilepsy, psychotic or bipolar disorder
  • History of near-miss or auto accident during last 12 months
  • Employed in safety sensitive job (e.g. truck driver or airline pilot)
  • Working nights or rotating shifts
  • Regular use of alerting (e.g., modafinil) medications
  • Consumption of alcohol: Men: \> 4 drinks a day or \> 14 drinks per week
  • Women: \> 3 drinks a day or \> 7 drinks per week
  • If using sleep medications, the drug and/or dose changed in the past month
  • Depression
  • Medications for psychotic or bipolar disorders
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eileen R Chasens

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nursing

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 27, 2017

Study Start

November 1, 2017

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)