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
Verified date | June 2021 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
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 |
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