A Mind-Body Intervention for Diabetes Management: A Pilot Study

NCT04944264 | Completed

• 1 other identifier: STUDY02000298
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Managing type 1 diabetes is stressful. Stress physiology influences glucose metabolism. Continuous glucose monitors allow us to track glucose variability in the real-world environment. Managing stress and cultivating resiliency should improve diabetes management and reduce glucose variability. The study was designed as a randomized prospective cohort pre-post study with wait time control. Participants were adult type 1 diabetes patients who used a continuous glucose monitor and recruited from an academic endocrinology practice. The intervention was the Stress Management and Resiliency Training (SMART) program conducted over 8 sessions over web-based video conference software. The primary outcome measures were: Glucose variability, the Diabetes Self-Management questionnaire (DSMQ) and the Connor-Davidson Resiliency (CD-RISC) instrument.

Conditions

Diabetes Mellitus; Stress, Psychological; Stress, Physiological

Outcome Measures

Primary Outcomes (6)

• Glucose (mg/dl)

  Glucose levels measured via a continuous glucose monitor (CGM) in order to determine Mean, Median and Standard Deviation over 10 days total for both sleep time (10 PM to 6 AM) and active time (6 AM to 10 PM); data is automatically collected every 15 minutes

  duration of study, approximately 6 months

• Glucose standard deviation (SD)

  Glucose levels measured via a continuous glucose monitor (CGM) in order to determine Mean, Median and Standard Deviation over 10 days total for both sleep time (10 PM to 6 AM) and active time (6 AM to 10 PM); data is automatically collected every 15 minutes

  duration of study, approximately 6 months

• Glucose Management Indicator (GMI)

  Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using continuous glucose monitoring (CGM) values. Average glucose is derived from at least 12 days of CGM data

  duration of study, approximately 6 months

• Short Form - 6 Dimensions (SF-6D)

  Range 0 - 1. Higher is better an econometric preference-based index derived from 11 items of the SF-36, which are combined into six dimensions of health, with four to six levels each. It is used to estimate quality of life. The SF-6D describes 18,000 different health states.

  duration of study, approximately 6 months

• Diabetes Self-Management Questionnaire (DSMQ)

  Range 0 - 10. Higher is better The DSMQ is a 16-item questionnaire to assess self-care activities associated with glycemic control in patients with diabetes.

  duration of study, approximately 6 months

• Connor-Davidson Resilience Scale (CD-RISC)

  Range 0 - 25. Higher is better The CD-RISC assesses resilience and constitutes a 25 item questionnaire scored on a 5-point likert scale (rated 0-4). The total score ranges from 0-100, with higher scores indicating greater resilience.

  duration of study, approximately 6 months

Secondary Outcomes (2)

• Implementation barriers

  duration of study, approximately 6 months

• Implementation Facilitators

  duration of study, approximately 6 months

Study Arms (2)

Immediate start

ACTIVE COMPARATOR

Behavioral: Stress Management and Resiliency Training (SMART) program

Behavioral: Stress Management and Resiliency Training (SMART) program

Delayed start

ACTIVE COMPARATOR

Wait time control

Behavioral: Stress Management and Resiliency Training (SMART) program

Interventions

Stress Management and Resiliency Training (SMART) program BEHAVIORAL

The Stress Management and Resiliency Training (SMART) program (bensonhenryinstitute.org) is well validated comprehensive stress management program. It is designed to cultivate both the early recognition of stress in the mind and body, develop skills to mitigate stress and evoke the relaxation response and cultivate resiliency. It is an 8 session program, typically run in a live group setting. In this study's case it was delivered via a videoconferencing platform.

Delayed start; Immediate start

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of type 1 diabetes (diagnosis ≥ 5 years) treated exclusively with insulin by multiple (\>2 daily) injections or pump
• no prior use of a continuous glucose monitor; ages \> 21
• ability to read and speak English at the high school level
• ability and willingness to come to the clinic once per week for a mind-body group intervention.

You may not qualify if:

• major psychiatric illness
• severe diabetes complications under active treatment (i.e., retinal laser or injection treatments, dialysis, foot ulcers)
• pregnancy
• an inability to attend weekly mind-body group sessions

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 05055, United States

Location

Related Publications (1)

• Stahl JE, Ammana HR, Kwak L, Comi RJ. SMART-ly Managing Type 1 Diabetes - Modifying Glucose Metabolism With an Online Mind-Body Intervention: A Feasibility and Pilot Study. Front Clin Diabetes Healthc. 2022 Mar 3;3:802461. doi: 10.3389/fcdhc.2022.802461. eCollection 2022.

  PMID: 36992749 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Stress, Psychological

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 29, 2021
• Study Start: October 1, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)