Digital follow-up. Can well-regulated patients with type 2 diabetes have digital annual follow-up without compromising quality of care?

ISRCTN	ISRCTN11499301
DOI	https://doi.org/10.1186/ISRCTN11499301
Sponsor	Steno Diabetes Centers
Funder	Steno Diabetes Center Aarhus

Submission date: 09/07/2026
Registration date: 10/07/2026
Last edited: 09/07/2026

Recruitment status: Not yet 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

Mrs Kirsten Christensen
Scientific, Public

Palle Juel-Jensens Boulevard 11, indgang A
Aarhus
8200
Denmark

ORCID ID	0009-0000-0726-0575
Phone	+45 24600481
Email	kichis@rm.dk

Prof Annelli Sandbæk
Principal investigator

Palle Juel-Jensens Boulevard 11, indgang A
Aarhus
8200
Denmark

ORCID ID	0000-0003-1647-2646
Phone	+45 2128 2073
Email	anesnd@rm.dk

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Single
Purpose	Screening
Scientific title	Can well-regulated patients with type 2 diabetes followed by their general practitioner be offered digital follow-up without compromising quality of care?
Study objectives	The study will investigate whether digital annual follow-up can be implemented for patients with well-controlled type 2 diabetes (as defined by predefined indicators) without compromising treatment quality. Furthermore the study is purposed to gain knowledge on how general practice can safely differentiate care for people with type 2 diabetes with the aim of increasing health equity. In addition, the study contributes knowledge on how digital care can support differentiation in general practice. In this study, every second annual diabetes follow-up, is conducted remotely via email communication between the healthcare provider and the participant over a two-year intervention period. The primary outcome is HbA1c. It is hypothesized to have non-inferiority with respect to changes in HbA1c for the participant in the intervention group compared to a matched control group receiving standard annual follow-up. Secondary outcomes are other diabetes-related clinical indicators (e.g., LDL, eGFR), morbidity and primary and secondary healthcare utilization, where the analysis compares the change in these indicators between the intervention group and the matched control group.
Ethics approval(s)	Approved 25/06/2026, The Central Denmark Region Committees on Health Research Ethics (Skottenborg 26, Viborg, 8800, Denmark; +45 78410186; komite@rm.dk), ref: Sagsnr. 1-10-72-56-26
Health condition(s) or problem(s) studied	Type 2 diabetes (ICD-10: E11) and follow-up in general practice.
Intervention	The intervention consists of replacing annual in-person follow-up with a digital annual follow-up every second year. In this setting, digital annual follow-up means that communication between healthcare provider and the participant is conducted remotely via email. Blood glycated haemoglobin (HbA1c) is measured using HbA1c blood samples gained from the participants medical record. HbA1c must be sent to and analyzed at the local Department of Clinical Biochemistry. Analyses will follow the department’s standardized and accredited procedures. Point-of-care HbA1c measurements conducted in the GP clinic are not acceptable.
Intervention type	Behavioural
Primary outcome measure(s)	Blood glycated haemoglobin (HbA1c) measured using analysis of blood samples by the local Department of Clinical Biochemistry following standardized accredited procedures, with data obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 and 2 years
Key secondary outcome measure(s)	Total cholesterol level measured using analysis of blood samples by the local Department of Clinical Biochemistry following standardized accredited procedures, with data obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Low-density lipoprotein (LDL) cholesterol level measured using analysis of blood samples by the local Department of Clinical Biochemistry following standardized accredited procedures, with data obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Urinary albumin-to-creatinine ratio (UACR) measured using analysis of urine samples by the local Department of Clinical Biochemistry following standardized accredited procedures, with data obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Estimated glomerular filtration rate (eGFR) measured using analysis of blood samples by the local Department of Clinical Biochemistry following standardized accredited procedures, with data obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Smoking status measured using participant medical records and GP records at baseline, 1 year, and 2 years Weight measured using self-reported weight recorded on a personal bathroom scale or weight recorded in GP practice records at baseline, 1 year, and 2 years Blood pressure measured using home arm-cuff monitoring (three measurements each morning and three each evening for three consecutive days, averaged across all measurements and recorded in Webpatient.dk) or GP practice records at baseline, 1 year, and 2 years Primary healthcare utilization measured using the total number of GP consultations (face-to-face, telephone, video, or email) obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Secondary healthcare utilization measured using records of contacts with secondary healthcare obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Diabetes-related medication use measured using medication records obtained from medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years Comorbidities measured using medical records and the BI Data Warehouse for Central Region Denmark at baseline, 1 year, and 2 years
Completion date	30/11/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	600
Key inclusion criteria	1. eGFR >59 mL/min/1.73 m² 2. HbA1c: 2.1. <48 mmol/mol, or 2.2. 48–53 mmol/mol if the individual HbA1c treatment target is <53 mmol/mol 3. Urine albumin-to-creatinine ratio (UACR): 3.1. <30 mg/g, or 3.2. 30–300 mg/g with ongoing treatment with organ-protective medication: SGLT-2i or GLP1 agonist and RAS-blockade with ACE-I or ARB (ATC-code: C09, A10BK, A10BD, A10BJ) 4. LDL <2.6 mmol/L 5. Ability to use the Danish national healthcare website (www.sundhed.dk) 6. Ability to read and understand Danish
Key exclusion criteria	1. The following diagnosis, ICD-10 codes: 1.1. F00–F03: Dementia – all forms 1.2. F70-F79: Intellectual disability 1.3. I50: Heart failure 1.4. Z51.5: Palliative care. 1.5. Pregnancy (ICD-10 O00-O99) 2. Any diagnoses or circumstances, that by the GPs judgement, makes digital annual follow-up inadvisable or unsafe
Date of first enrolment	01/09/2026
Date of final enrolment	30/11/2026

Locations

Countries of recruitment

Denmark

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request to Kirsten Christensen, kichis@rm.dk.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 4	25/06/2026	09/07/2026	No	No

Additional files

49877_Protocol_V4_25June2026.pdf: Protocol file

Editorial Notes

09/07/2026: Study’s existence confirmed by the Scientific Ethics Committees for the Central Denmark Region, Committee II.