Clinical trial NCT04944264: A Mind-Body Intervention for Diabetes Management: A Pilot Study
Official title: SMART Management of Type 1 Diabetes - Modifying Glucose Metabolism With an Online Mind-body Intervention: A Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Stress, Psychological
Stress, Physiological
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose (mg/dl)
timeFrame: duration of study, approximately 6 months
measure: Glucose standard deviation (SD)
timeFrame: duration of study, approximately 6 months
measure: Glucose Management Indicator (GMI)
timeFrame: duration of study, approximately 6 months
measure: Short Form - 6 Dimensions (SF-6D)
timeFrame: duration of study, approximately 6 months
measure: Diabetes Self-Management Questionnaire (DSMQ)
timeFrame: duration of study, approximately 6 months
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: duration of study, approximately 6 months
Secondary outcomes:
measure: Implementation barriers
timeFrame: duration of study, approximately 6 months
measure: Implementation Facilitators
timeFrame: duration of study, approximately 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
References: