Diabetes Diabetes
Conditions
Interventions
The investigational device is the MELISSA application which consists of two 
AI-driven features: the ABBA algorithm (providing personalised insulin dose 
advice) and goFOODTM (a system for estimation of a meals* energy- and 
macronutrient content).
Sponsors
Universiteit Maastricht
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Time from diagnosis of T1D or T2D >=1 year 2. Age between 16 years to 80 years including both age limits 3. On intensive insulin treatment >= 1 year 4. HbA1c of 48 mmol/mol to 86 mmol/mol (6.5% to 10%) up to six months before screening 5. Mode of blood glucose monitoring: BGM or is-/rtCGM 6. Sufficient knowledge about food and CHOs at the investigator*s discretion 7. Willing and able to follow the MELISSA protocol specifications 8. BMI >=18.5 kg/m2 and
Exclusion criteria
Exclusion criteria: 1. Professional drivers, sailors, or pilots 2. People working night shifts 3. Pregnancy or breastfeeding or planning on pregnancy for the duration of the trial 4. Treatment with glucose-lowering medications other than metformin and/or sodium glucose cotransporter 2 (SGLT2) inhibitors and/or glucagon-like peptide-1 (GLP-1) analogues and/or dipeptidyl peptidase IV (DPPIV) inhibitors 5. Use of insulin pumps or automatic insulin delivery systems 6. Use of antipsychotic drugs and/or immune-modifying drugs and/or systemic glucocorticoids except from oral prednisolone equivalents <=10 mg/day and on a stable dose that is not expected to change during the trial at the investigator*s discretion 7. Carbohydrate-restricted (<45g/day) or other extreme diets at the investigator*s discretion 8. Clinically significant eating disorders at the investigator*s discretion 9. Severe medical or psychological conditions interfering with the perception of acute diabetes complications at the investigator*s discretion 10. Unstable cardiovascular disease (major adverse cardiovascular event in the last 6 months), active malignancy (chemotherapy or palliation therapy in the last 6 months), kidney failure (eGFR < 30 mL/min/1.73 m2), and/or dialysis 11. Abuse of alcohol or other substances at the investigator*s discretion. 12. Hypersensitivity to the CGM sensor band-aid 13. Current or recent participation (within the last three months) in clinical trials/research projects with the participant receiving trial medication at the investigator*s discretion 14. Severe cognitive impairment preventing participants from using the trial devices at the investigator*s discretion 15. Anasarca, i.e., severe, and general oedema (CGM contraindication) 16. Prescription of hydroxyurea (CGM contraindication) 17. Gastroparesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change in the percentage of time glucose levels fall within target values (TIR: 3.9-10.0 mmol/L [70-180 mg/dL]), measured with a blinded CGM (continuous glucose monitor), from baseline to end of study at 16 weeks between the two study arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include additional glycaemic outcomes (e.g., hypoglycaemia, times below and above range, and glycaemic variability), MELISSA-, ABBA-, goFOODTM-, nutritional-, health and metabolic related outcomes and patient-reported outcomes (e.g., diabetes distress and fear of hypoglycaemia). | — |
Countries
Denmark, Greece, Netherlands
Contacts
Public ContactCFBA Dingena
Universiteit Maastricht
Outcome results
None listed