InsomniaDSTT-INCT03064321
Diabetes Sleep Treatment Trial for Insomnia
A study testing Insomnia Intervention in people with Insomnia and Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Diabetes Mellitus, Type 2
- What is being tested?
- Insomnia Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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].
Who cannot join
- 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
Show all 17Show fewer
- 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
- No internet access
- Pregnant or intend to become pregnant in the next four months (postmenopausal or confirmed not pregnant by a urine pregnancy test)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Self-Management, Insomnia, and Glucose Control in Adults With Diabetes
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).
Read the detailed description
Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.
- Conditions
- Insomnia, Diabetes Mellitus, Type 2
- Being tested
- Insomnia Intervention, Information Control
- Keywords
- cognitive behavioral treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia InterventionBehavioural
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.
Information ControlOther
Information on websites that are general health promoting
| Study group | Role | What they receive |
|---|---|---|
| Insomnia Intervention | Experimental | Insomnia intervention delivered via web using Cognitive Behavior Treatment Receives: Behavioral: Insomnia Intervention |
| Information Control | Other | General health information website Receives: Other: Information Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Glucose Control for Last 3 Months Assessed by A!C level
A1C level
Measured: After 12 weeks of either the insomnia intervention or the information control intervention
Secondary outcomes (1)
Sleep Quality
Scores on the Pittsburgh Sleep Quality Index questionnaire
Measured: After 12 weeks of either the insomnia intervention or the information control intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Nov 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Two group design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen R. Chasens, University of Pittsburgh
- Investigators
- Eileen R Chasens, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064321
- Sponsor's protocol ID
- K24NR016685-01A1
- Acronym
- DSTT-I
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management, Insomnia, and Glucose Control in Adults With Diabetes
- ClinicalTrials.gov ID
- NCT03064321
- Acronym / sponsor ID
- DSTT-I / K24NR016685-01A1
- Conditions
- Insomnia, Diabetes Mellitus, Type 2
- Keywords
- cognitive behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group design
| Arm | Type | Receives |
|---|---|---|
| Insomnia Intervention | Experimental | Behavioral: Insomnia InterventionInsomnia intervention delivered via web using Cognitive Behavior Treatment |
| Information Control | Other | Other: Information ControlGeneral health information website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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].
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Insomnia InterventionThe 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. | Behavioural | Insomnia Intervention |
| Information ControlInformation on websites that are general health promoting | Other | Information Control |
Primary outcome
Average Glucose Control for Last 3 Months Assessed by A!C level
Time frame: After 12 weeks of either the insomnia intervention or the information control intervention
A1C level
1 secondary outcome
Sleep Quality
Time frame: After 12 weeks of either the insomnia intervention or the information control intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
Eileen R Chasens principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia Intervention in people with Insomnia and Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site 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 5 inclusion and 17 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Glucose Control for Last 3 Months Assessed by A!C level (time frame: After 12 weeks of either the insomnia intervention or the information control intervention). 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 10 Feb 2021.