Diabetes Mellitus, Type 1TOHCD-DNCT07275086
Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes
A study testing Swedish massage in people with Diabetes Mellitus, Type 1, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Swedish massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe diabetes complications (e.g., advanced neuropathy)
- Acute psychiatric disorder requiring treatment
- Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Magnus Wijkman, PhD/MD contact
About this study
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.
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
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Swedish massage
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Swedish massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HbA1c (mmol/mol)
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.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of Copeptin (pmol/L)
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.
Measured: Baseline and within 7 days after final massage (5 weeks).
Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L)
Limited efficacy outcome assessing preliminary within-group inflammatory changes.
Lower concentrations indicate reduced systemic inflammation
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of Interleukin-6 (IL-6) (pg/mL)
Limited efficacy outcome assessing preliminary within-group inflammatory changes.
Lower IL-6 levels indicate reduced inflammatory activation.
Measured: 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)
Limited efficacy outcome assessing preliminary within-group changes in glycemic control.
Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Glycemic variability (Coefficient of Variation, %), measured by CGM
Limited efficacy outcome assessing preliminary within-group changes in glycemic stability.
Lower %CV indicates more stable glucose levels.
Measured: 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)
Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Score on the Perceived Stress Scale-10 (PSS-10)
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.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Score on the Generalized Anxiety Disorder-7 (GAD-7)
Limited efficacy outcome assessing preliminary within-group psychological changes.
The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Concentration of fasting plasma glucose (mmol/L)
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.
Measured: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Secondary outcomes (2)
Change in Systolic Blood Pressure
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.
Measured: Baseline and within 7 days after the final massage session (5 weeks).
Change in Diastolic Blood Pressure
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.
Measured: Baseline and within 7 days after the final massage session (5 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Peter Johansson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275086
- Sponsor's protocol ID
- 2025-05625
- Other IDs
- 2025
- Acronym
- TOHCD-D
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to the small sample size and sensitive clinical information. De-identified summary data may be available upon reasonable request to the principal investigator for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07275086
- Acronym / sponsor ID
- TOHCD-D / 2025-05625
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Swedish Massage | Experimental | Behavioral: Swedish massageParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Severe diabetes complications (e.g., advanced neuropathy)
- Acute psychiatric disorder requiring treatment
- Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swedish massageParticipants 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. | Behavioural | Swedish Massage |
Primary outcome
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.
2 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to the small sample size and sensitive clinical information. De-identified summary data may be available upon reasonable request to the principal investigator for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Wijkman, PhD/MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish massage in people with Diabetes Mellitus, Type 1, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Johansson, Professor/RN (460700896548, peter.b.johansson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HbA1c (mmol/mol) (time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.