Diabetes Intervention Involving Person-centred Nutritional Education
ConditionDiabetes Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet.
The main question the trial aims to answer is:
Does a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information?
The participants will:
* Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group). * Wear their sensor for continuous glucose monitoring (CGM) throughout the trial. * Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial. * Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 1 Diabetes.
Diabetes duration for more than 12 months at screening.
Adults 18 years or older.
HbA1c more than 57mmol/mol.
Disqualifiers
Women of childbearing potential: ongoing pregnancy or planned pregnancy during the study period.
Cognitive impairment or other disease that study physician find non-compatible with participation.
Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).
Planned change of CGM sensor during the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary intervention
BehavioralA person-centred education focussed on creating partnerships in care and shared decision-making.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Person-centred nutritional educationExperimental treatment 1 intervention
Group B: Short dietary informationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.
Percentage of time spent with glucose levels between 3.9-10 mmol/l measured with continuous glucose monitor (CGM) over 10-14 days.
Time frame
Week 1, 12 and 24.Secondary outcomes
1
Adherence to a Nordic diet.
Evaluation and analysis of diet data from Food frequency questionnaire (FFQ) and food diary.
Time frame
Week 1 and 24.2
Glycosylated Hemoglobin (HbA1c).
HbA1c represents overall glycaemic control over the last three months.
Time frame
Week 1 and 24.3
Time above range - percentage of time spent with blood glucose levels above 10.0 mmol/L and 13.9 mmol/L respectively.
Percentage of time with high blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Time frame
Week 1, 12 and 24.4
Time below range - percentage of time spent with blood glucose levels below 3.9 mmol/L and 3.0 mmol/L respectively.
Percentage of time with low blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Time frame
Week 1, 12 and 24.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Umeå University
Lead sponsor
Lasarettet i Enköping
Collaborator
Source ClinicalTrials.gov