Diabetes Mellitus, Type 1
Conditions
Brief summary
This pilot study evaluates potential biological and psychological effects of Swedish massage in adults with type 1 diabetes. Massage may influence stress-related mechanisms, such as hypothalamic-pituitary-adrenal (HPA) axis activity and inflammation, which are linked to impaired insulin sensitivity and glycemic control. Twenty participants with type 1 diabetes will receive weekly 45-60-minute Swedish massage sessions for five weeks. Biological outcomes include HbA1c, fasting glucose, copeptin, hs-CRP, IL-6, and TNF-α. Glycemic variability will be assessed using continuous glucose monitoring (CGM). Psychological outcomes include perceived stress (PSS-10) and anxiety (GAD-7). The study aims to explore feasibility, acceptability, and preliminary within-group effects on stress regulation and glycemic balance
Interventions
BEHAVIORALSwedish massage
Participants receive Swedish massage once weekly for five consecutive weeks. Each 45-60-minute session is delivered by a licensed massage therapist using traditional Swedish techniques (kneading, gliding, and tapping) focusing on the back, shoulders, and neck. The intervention aims to promote relaxation and modulate stress-related biological systems. The study uses a single-group pre-post design to explore biological and psychological effects and feasibility.
Sponsors
Linkoeping University
University Hospital, Linkoeping
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open-label single-group pilot study; neither participants nor investigators are blinded.
Intervention model description
All participants receive Swedish massage once weekly for five weeks. Pre-post within-group design to explore biological and psychological effects and study feasibility.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) with type 1 diabetes ≥ 1 year * Able to attend two assessment visits at Vrinnevi Hospital * Uses CGM or equivalent system * Able to communicate in Swedish and provide consent
Exclusion criteria
* Severe diabetes complications (e.g., advanced neuropathy) * Acute psychiatric disorder requiring treatment * Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of fasting plasma glucose (mmol/L) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group metabolic changes prior to a future randomized trial. Fasting plasma glucose (mmol/L), with lower values indicating improved glycemic control. |
| Time in Range (percentage of CGM readings between 3.9-10 mmol/L) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation. |
| Score on the Perceived Stress Scale-10 (PSS-10) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group psychological changes. The PSS-10 is a 10-item scale ranging 0-40, with higher scores indicating greater perceived stress. |
| Score on the Generalized Anxiety Disorder-7 (GAD-7) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety. |
| Concentration of HbA1c (mmol/mol) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. HbA1c (mmol/mol), measured from fasting blood samples. Lower values indicate improved glycemic control. |
| Concentration of Copeptin (pmol/L) | Baseline and within 7 days after final massage (5 weeks). | Limited efficacy outcome assessing preliminary within-group changes related to physiological stress. Copeptin measured from fasting serum samples. Lower concentrations indicate reduced stress system activation. |
| Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation |
| Concentration of Interleukin-6 (IL-6) (pg/mL) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation. |
| Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM) | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control. |
| Glycemic variability (Coefficient of Variation, %), measured by CGM | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline and within 7 days after the final massage session (5 weeks). | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. Clinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile. |
| Change in Diastolic Blood Pressure | Baseline and within 7 days after the final massage session (5 weeks). | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. Clinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Metabolic and Inflammatory Markers | Change from baseline to within 7 days after the fifth massage session (5 weeks). | Additional biomarkers related to stress physiology, inflammation, or short-term glycemic control may be analyzed if relevant and assay-ready samples are available (e.g., additional cytokines, oxidative stress markers, or alternative glycemic indices). These outcomes are exploratory and not required for completion of the study. |
Countries
Sweden
Contacts
Primary ContactPeter Johansson, Professor/RN
Backup ContactMagnus Wijkman, PhD/MD
Outcome results
None listed