48 Participants NeededMy employer runs this trial

Cognitive Behavioral Intervention for Type 1 Diabetes

Recruiting at 1 trial location
SG
Overseen ByStephanie Griggs, PhD, RN, FAAN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SG

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

One or more sleep health dimensions are out of range
I am between 31 and 75 years old.
I have had Type 1 Diabetes for at least one year.

Exclusion Criteria

Non-English speaking
Recent night shift work or transmeridian travel
Presence of a life-limiting illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive behavioral intervention aimed at improving lifestyle and glucose targets

14 weeks
Regular sessions with a health coach

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention ArmExperimental Treatment1 Intervention
Group II: Enhanced Usual Care (EUC) ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

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' ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36927461/

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.