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

Diabetes Mellitus Clinical Trial

Official title:

SMART Management of Type 1 Diabetes - Modifying Glucose Metabolism With an Online Mind-body Intervention: A Feasibility and Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944264
• Other study ID #: STUDY02000298
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 15, 2021

Study information

• Verified date: June 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hypothesis: It was hypothesized that the course on videoconferencing platform would deliver similar effects on quality of life as has been seen in the past from on-site courses, and that the intervention would reduce glucose variability and improve resiliency Design: This pilot was designed as a prospective cohort pre-post intervention study with subjects randomized to an immediate start or wait time control The study was approved by the Committee for the Protection of Human Subjects at Dartmouth Hitchcock Medical Center and Dartmouth College. All participants provided written informed consent.

Intervention: 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. This was done both as a means of testing delivering this service in a rural setting where patient might be geographically distant or isolated and to accommodate the need for social distancing during the COVID-19 pandemic.

Recruitment: Recruitment occurred through the Dartmouth-Hitchcock Medical Center (DHMC) endocrinology clinic and the endocrinologists working there. Candidates were included if they had type 1 diabetes and used a continuous glucose monitor. Candidates were excluded if they were < 21 years old and could not give informed consent. To allow for controlled analysis, on presentation at each site, participants were randomly assigned to one of two cohorts: 1) immediate start (A) and 2) delayed start (B). The immediate arm began at the next available class. The delayed start group began 4 weeks later. During their wait, this group was offered usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• Stress Management and Resiliency Training (SMART) program
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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Implementation barriers	Qualitative feedback from participants regarding implementation barriers of the SMART-3RP program for patients with type 1 diabetes	duration of study, approximately 6 months
Secondary	Implementation Facilitators	Qualitative feedback from participants regarding Implementation Facilitators of the SMART-3RP program for patients with type 1 diabetes	duration of study, approximately 6 months