The effect of a structured group education programme combined with continuous glucose monitoring in people with type 2 diabetes on non-insulin therapy

ISRCTN	ISRCTN16690433
DOI	https://doi.org/10.1186/ISRCTN16690433
Sponsor	University Medical Centre Ljubljana
Funder	Investigator initiated and funded

Submission date: 02/10/2026
Registration date: 02/10/2026
Last edited: 02/10/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Miodrag Janić
Public, Principal investigator, Scientific

Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
Ljubljana
1000
Slovenia

ORCID ID	0000-0001-7073-8922
Phone	+386 15224756
Email	miodrag.janic@kclj.si

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment, Education
Scientific title	Structured group education combined with real-time continuous glucose monitoring compared to standard education in adults with type 2 diabetes on non-insulin therapy evaluating glycemic effects and diabetes distress
Study acronym	TABLETKA
Study objectives	Ascertain whether the structured education programme Tabletka provides additive glycaemic and psychological benefits compared to standard education in people with type 2 diabetes on non-insulin therapy when both groups use real-time continuous glucose monitoring.
Ethics approval(s)	Approved 23/09/2025, National Medical Ethics Committee of the Republic of Slovenia (Štefanova ulica 5, Ljubljana, 1000, Slovenia; +386 14786001; gp.mz@gov.si), ref: 0120-464/2025-2711-3
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Intervention arm 1: Participants receive the Tabletka programme, comprising 10 contact hours delivered in four interactive meetings (two group workshops and two individual counselling sessions) by registered nurse educators. Participants wear a blinded Syai Tag rtCGM sensor for 14–30 days pre-intervention, followed by two consecutive unblinded sensors (14 days each) during the programme. Intervention arm 2: Participants receive the Tabletka programme, comprising 10 contact hours delivered in four interactive meetings (two group workshops and two individual counselling sessions) by registered nurse educators. Participants wear 2 blinded Syai Tag rtCGM sensors for 14 days each during the programme. Control arm: Participants receive standard care, consisting of a one-hour group education session on healthy lifestyle. Participants wear two consecutive unblinded Syai Tag rtCGM sensors. Both arms maintain unchanged glucose-lowering medication throughout the study, with a total follow-up duration of approximately 90 days after the last sensor period.
Intervention type	Behavioural
Primary outcome measure(s)	Time in tight range measured using TITR, 3.9–7.8 mmol/L at the end of the sensor period (28 days) Time in range measured using TIR, 3.9–10.0 mmol/L at the end of the sensor period (28 days) Diabetes distress measured using PAID-20 questionnaire at baseline and at the final visit (approximately 90 days after the last sensor period)
Key secondary outcome measure(s)	HbA1c measured using blood test at baseline and at the final visit (approximately 90 days after the last sensor period) Body weight measured using kg at baseline and at the final visit. Glycaemic variability (TAR, TBR, GMI, CV, MAGE, MODD) measured using mmol/L; % at the end of the sensor period (28 days)
Completion date	01/10/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	40
Total final enrolment	100
Key inclusion criteria	1. Adults (≥ 18 years) with newly diagnosed type 2 diabetes or a diagnosis within the previous five years 2. HbA1c ≥ 6.0% (42 mmol/mol) 3. Unchanged non-insulin glucose-lowering therapy for at least three months
Key exclusion criteria	1. Current or past insulin therapy 2. Type 1 or other specific diabetes types 3. Conditions limiting participation in education (e.g., cancer, stroke, dialysis dependence) 4. Uncontrolled psychiatric or neurological comorbidity 5. Life expectancy below six months 6. Requiring any change in glucose-lowering therapy during the study
Date of first enrolment	01/10/2025
Date of final enrolment	31/05/2026

Locations

Countries of recruitment

Slovenia

Study participating centre

Department of Endocrinology, Diabetes and Metabolic Diseases, Division of Internal Medicine, University Medical Centre Ljubljana

Zaloška 7
Ljubljana
1000
Slovenia

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

02/10/2026: Trial's existence confirmed by National Medical Ethics Committee of the Republic of Slovenia.