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

Primary Purpose

Diabetes Mellitus, Stress, Psychological, Stress, Physiological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resiliency Training (SMART) program
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate start

Delayed start

Arm Description

Behavioral: Stress Management and Resiliency Training (SMART) program

Wait time control

Outcomes

Primary Outcome Measures

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
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
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
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.
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.
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.

Secondary Outcome Measures

Implementation barriers
Qualitative feedback from participants regarding implementation barriers of the SMART-3RP program for patients with type 1 diabetes
Implementation Facilitators
Qualitative feedback from participants regarding Implementation Facilitators of the SMART-3RP program for patients with type 1 diabetes

Full Information

First Posted
June 9, 2021
Last Updated
June 19, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04944264
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Stress, Psychological, Stress, Physiological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate start
Arm Type
Active Comparator
Arm Description
Behavioral: Stress Management and Resiliency Training (SMART) program
Arm Title
Delayed start
Arm Type
Active Comparator
Arm Description
Wait time control
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resiliency Training (SMART) program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glucose (mg/dl)
Description
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
Time Frame
duration of study, approximately 6 months
Title
Glucose standard deviation (SD)
Description
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
Time Frame
duration of study, approximately 6 months
Title
Glucose Management Indicator (GMI)
Description
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
Time Frame
duration of study, approximately 6 months
Title
Short Form - 6 Dimensions (SF-6D)
Description
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.
Time Frame
duration of study, approximately 6 months
Title
Diabetes Self-Management Questionnaire (DSMQ)
Description
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.
Time Frame
duration of study, approximately 6 months
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
duration of study, approximately 6 months
Secondary Outcome Measure Information:
Title
Implementation barriers
Description
Qualitative feedback from participants regarding implementation barriers of the SMART-3RP program for patients with type 1 diabetes
Time Frame
duration of study, approximately 6 months
Title
Implementation Facilitators
Description
Qualitative feedback from participants regarding Implementation Facilitators of the SMART-3RP program for patients with type 1 diabetes
Time Frame
duration of study, approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
05055
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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