---
title: Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes
nct_id: NCT07275086
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: University Hospital, Linkoeping
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus, Type 1
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07275086.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07275086"
ct_last_update_post_date: 2025-12-10
last_seen_at: "2026-05-12T07:04:32.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

**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.

**NCT ID:** [NCT07275086](https://clinicaltrials.gov/study/NCT07275086)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University Hospital, Linkoeping
- **Collaborators:** Linkoeping University
- **Conditions:** Diabetes Mellitus, Type 1
- **Start Date:** 2026-09-01
- **Completion Date:** 2027-02-01
- **CT.gov Last Update:** 2025-12-10

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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)
```

## Arms

- **Swedish Massage** (EXPERIMENTAL) — Participants receive Swedish massage once weekly for five consecutive weeks. Each session lasts 45-60 minutes and is delivered by a licensed massage therapist. Techniques include kneading, gliding, and tapping of soft tissues, focusing on the back, shoulders, and neck. The massage is designed to promote relaxation and modulate stress-related biological systems

## Interventions

- **Swedish massage** (BEHAVIORAL) — 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 Outcomes

- **Concentration of HbA1c (mmol/mol)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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)** _(time frame: 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** _(time frame: 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.
- **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).)_ — Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.
- **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).)_ — 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)** _(time frame: 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 fasting plasma glucose (mmol/L)** _(time frame: 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.

## Secondary Outcomes

- **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).)_

## Locations (1)

- Peter Johansson, Norrköping, Linköpings Universitet, Sweden

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peter johansson|norrköping|linköpings universitet|sweden` — added _(2026-05-12)_

---

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