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Not yet recruiting NCT07275086

Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

No phase Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Swedish massage.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes (TOUCH-D): A Pilot Single-group Feasibility Study Evaluating Biological and Psychological Effects of Swedish Massage in Adults With Type 1 Diabetes.

Overview

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

  • Behavioral Swedish 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.

Primary outcome measures

  • Concentration of HbA1c (mmol/mol) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Concentration of Copeptin (pmol/L) [Time frame: Baseline and within 7 days after final massage (5 weeks).]
  • Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Concentration of Interleukin-6 (IL-6) (pg/mL) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Glycemic variability (Coefficient of Variation, %), measured by CGM [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Time in Range (percentage of CGM readings between 3.9-10 mmol/L) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Score on the Perceived Stress Scale-10 (PSS-10) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Score on the Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
  • Concentration of fasting plasma glucose (mmol/L) [Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).]
Secondary outcome measures (2)
  • Change in Systolic Blood Pressure [Time frame: Baseline and within 7 days after the final massage session (5 weeks).]
  • Change in Diastolic Blood Pressure [Time frame: Baseline and within 7 days after the final massage session (5 weeks).]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Sweden · 1 center
  • Peter Johansson — Norrköping

Identifiers

NCT: NCT07275086 · 2025-05625

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗