An observational study in Type 2 Diabetes, sponsored by TNO. Recruiting at 1 site in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by TNO · Observational
Rationale: Lifestyle changes in diet and exercise can reverse type 2 diabetes (T2D), also referred to as T2D remission. Although combined lifestyle interventions for T2D remission are promising, not all persons react similarly to such 'one-size-fits-all' interventions. Research has shown that as a result of differences in T2D pathophysiology between individuals, different subgroups of T2D can be identified, that differ in which diet is most beneficial in the recovery of pancreatic beta-cell function. TNO and partners work on the development of the Diabetyping Lifestyle Intervention (DLI) for T2D subtypes that tailors the combined lifestyle intervention based on organ dysfunction (liver, muscle and/or pancreatic beta cell function) by using the Oral Glucose Tolerance Test (OGTT). Current diabetyping is invasive, needs to take place in a clinical setting, and therefore is not suited for scaling to application in the large T2D population of more than 1 million people. Therefore, less invasive, scalable alternatives are warranted.
Objective: The main objective of the 2DIAREM study is to develop minimally invasive alternatives of diabetyping. Two alternative sampling methods will be evaluated, finger pricks and continuous glucose monitoring (CGM). Data collected through these technologies may be used to predict OGTT indices and diabetypes to guide personalized lifestyle interventions for T2D patients. Furthermore, the investigators aim to develop and evaluate the minimally invasive diabetyping technology with algorithms based on finger prick sampling and multi-day CGM upon a standardized snack or multi-day CGM only under real-world conditions.
Study design: The study will be an observational study, lasting 20 days and consisting of three mornings with measurements.
Study population: A heterogenous group of people with overweight/(pre)diabetes type 2. The investigators aim for equal distribution among overweight/prediabetes, mild diabetes, and severe diabetes in the study population.
Intervention (if applicable): During the 20 days of monitoring participants are asked to undergo one OGTT and consume two times a standardized snack (Snelle Jelle (naturel 65 gram)) after an overnight fast. In between participants are asked to follow their usual lifestyle.
Main study parameters/endpoints: Continuously measured subcutaneous glucose, as well as, glucose and insulin, and c-peptide collected via capillary sampling for the development of algorithms predicting the different diabetypes and the underlying indices based on venous blood glucose and insulin.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of this study consists of the application and removal of the continuous glucose monitor device, and the consumption of a sweet beverage (OGTT) and two standardized snacks and undergoing several capillary blood draws. The risks associated with participation can be considered negligible, and are mainly associated with the glucose sensor and the OGTT. The glucose sensor provides a small risk of adverse events including skin irritation, skin infection, and skin colouring. The OGTT poses a small risk of hypo- or hyperglycaemia and can lead to nausea. However, experienced medical professionals are present at the clinic and will closely monitor well-being and health status of the study participants. Benefits include that data collected through the technologies may be used to predict OGTT indices and diabetypes much less invasively and scalable to guide personalized lifestyle interventions for T2D patients.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 57 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →TNO is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of people with overweight/prediabetes, mild diabetes and severe diabetes, as diagnosed by BMI, disease duration, medication use and CVD history. The three subpopulations are selected to ensure representative variability in OGTT response and diabetes subtypes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with (pre)diabetes type 2;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glucose values (mmol/l)
Measured in venous blood, capillary blood and interstitial fluid (via the CGM) before and during the OGTT
Time frame: In-study at day 3 and day 17 (venous and capillary) during 20 days with CGM
Insulin (mIU/l)
Measured in venous blood and capillary blood before and during the OGTT
Time frame: In-study at day 3 and day 17 (venous and capillary)
c-peptide (nmol/l)
Measured in venous blood and capillary blood before and during the OGTT
Time frame: In-study at day 3 and day 17 (venous and capillary)
Diabetyping
Development of algorithms predicting the different diabetypes and the underlying indices with minimally invasive data collection (e.g. capillary blood sampling with sample tube/dry blood spot and CGM)
Time frame: End of study (after 20 days)
Glucose values (mmol/l)
Measured in capillary blood, venous and interstitial fluid (via the CGM) before and during the standardized snack
Time frame: In-study at day 8 (capillary) and day 17 (venous and capillary) during 20 days with CGM
Insulin (mIU/l)
Measured in capillary blood, venous and interstitial fluid (via the CGM) before and during the standardized snack
Time frame: In-study at day 8 (capillary) and day 17 (venous and capillary)
c-peptide (nmol/l)
Measured in capillary blood, venous and interstitial fluid (via the CGM) before and during the standardized snack
Time frame: In-study at day 8 (capillary) and day 17 (venous and capillary)
Diabetyping
Assess the agreement between diabetyping based on a standardized snack as compared to the OGTT
Time frame: End of study (after 20 days)
Self-reported experiences with capillary blood sampling in an at home setting
Via a self composed questionnaire with open and closed questions
Time frame: End of study (day 19)
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