Cognitive Behavioral Intervention for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cognitive behavioral intervention can help adults with type 1 diabetes improve their lifestyle and better manage blood sugar levels. Researchers will divide participants into two groups: one will receive usual care with additional attention (Attention Control Enhanced Usual Care Arm), and the other will try a new approach to improve sleep patterns (TranS-C Intervention Arm). The study seeks adults who have had type 1 diabetes for at least a year and are experiencing sleep issues. Those dealing with this form of diabetes and sleep difficulties might find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance quality of life.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Transdiagnostic Sleep and Circadian Intervention (TranS-C) is generally safe. Studies found that this treatment improved sleep without causing major side effects. Participants reported better sleep and reduced depression, indicating that the treatment is well-tolerated. The primary goal is to enhance sleep patterns, benefiting overall health. No clear evidence links this treatment to serious negative effects. This intervention is designed to be safe for individuals with sleep issues and type 1 diabetes.12345
Why are researchers excited about this trial?
Researchers are excited about the Cognitive Behavioral Intervention for Type 1 Diabetes trial because it explores innovative ways to manage the condition by addressing sleep and circadian rhythms. Unlike standard care, which often focuses on insulin management and diet, the TranS-C Intervention targets sleep quality and consistency, aiming for 7-9 hours of sleep per night with less than 60 minutes' variation in sleep and wake times. This approach is unique because it considers the role of sleep in diabetes management, which could lead to better overall health and potentially improved blood sugar control. By working with health coaches, participants might see benefits beyond traditional diabetes treatments.
What evidence suggests that this trial's treatments could be effective for type 1 diabetes?
Research has shown that the TranS-C program, which participants in this trial may receive, can improve sleep quality and reduce insomnia severity. One study found that individuals using this method experienced significant improvements in sleep and a decrease in insomnia symptoms. Better sleep is linked to improved overall well-being and may aid blood sugar control in people with type 1 diabetes. Although the direct effects on blood sugar remain unproven, focusing on sleep and body clock health appears promising for supporting lifestyle changes and managing diabetes. Meanwhile, participants in the Enhanced Usual Care (EUC) Arm will work with a health coach focused on enhanced usual care.24678
Who Is on the Research Team?
Stephanie Griggs, PhD, RN, FAAN
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for adults aged 31 to 75 who have had type 1 diabetes for at least a year and are experiencing sleep problems. People can't join if they don't speak English, recently worked night shifts or traveled across time zones, or have a serious life-limiting illness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a cognitive behavioral intervention aimed at improving lifestyle and glucose targets
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Attention Control Enhanced Usual Care (EUC) Arm
- TranS-C Intervention Arm
Trial Overview
The study compares two approaches: an enhanced usual care program versus a cognitive behavioral therapy (CBT) intervention called TranS-C, to see which better helps people with type 1 diabetes improve their sleep and blood sugar control.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times.
Participants will work with a health coach focused on enhanced usual care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Citations
A Randomized Pilot Sleep and Circadian Behavior Clinical ...
Aims: To investigate the preliminary efficacy of a cognitive behavioral sleep and circadian intervention on glycemic and psychological outcomes ...
Efficacy of a Transdiagnostic Sleep and Circadian ...
The intervention group statistically significantly improved sleep quality (p < 0.001), reduced insomnia severity (p < 0.001), and increased well ...
NCT07522866 | Thrive With Type 1 Diabetes 2026
Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' ...
The Transdiagnostic Intervention for Sleep and Circadian ...
TranS-C was designed to target a range of SMI diagnoses by addressing a probable mechanism and predictor of SMI: sleep and circadian problems.
The effect of cognitive behavioral therapy for insomnia on ...
CBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia ...
study protocol for a randomized controlled trial - Springer Nature
The aim of the study is to investigate the efficacy of a transdiagnostic sleep intervention for patients with sleep problems comorbid to bipolar ...
NCT03617770 | A Sleep Intervention in Type 1 Diabetes
The purpose of this pilot and feasibility trial is to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of ...
Sleep Quality and Glycemic Control in Type 1 Diabetes
This study aimed to observe sleep quality in T1D patients and glycemic outcomes, particularly at bedtime hours.
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