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New treatment option for Diabetes Type 1
Official title EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation
ClinicalTrials.gov ID: NCT06738849
What this study is testing
- What it's testing
- EkiYou-Study-2 is an interventional multicenter randomised controlled clinical investigation according to EU 2017/745. It is conducted in 154 adults with diabetes and treated by multiple daily insulin injections that will be followed for 6 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- be aged 18 or over,
- have type 1 or type 2 diabetes or diabetes secondary to pancreatic disease,
- have been treated with multi-injection basal/bolus insulin therapy for at least 6 months,
- using a compatible rapid insulin with the device Ekiyou such as : Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp or Lyumjev,
- using a compatible long-acting insulin with the device EkiYou such as : Lantus, Abasaglar, Toujeo, Levemir or Tresiba,
You likely can't join if
- pregnant or breast-feeding women,
- type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors),
- insulin-resistant patient: prescribed daily insulin dose \> 1 U/kg/day or \> 200 U/day,
- patient with very low insulin requirements: daily insulin dose \< 15 U/day,
- patient with gastroparesis,
- diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion,
See the full eligibility criteria
- be aged 18 or over,
- have type 1 or type 2 diabetes or diabetes secondary to pancreatic disease,
- have been treated with multi-injection basal/bolus insulin therapy for at least 6 months,
- using a compatible rapid insulin with the device Ekiyou such as : Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp or Lyumjev,
- using a compatible long-acting insulin with the device EkiYou such as : Lantus, Abasaglar, Toujeo, Levemir or Tresiba,
- have been using a continuous glucose monitoring device such as Dexcom G6, Dexcom One, Dexcom One+ or FreeStyle Libre for at least 3 months,
- have given their physician access to their glucose data via a glucose data management platform,
- for type 2 diabetic patients using an hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors), have no change in dosage regimen for at least 3 months
- have recorded at least 70% of CGM data over a 14-day window close to the inclusion date,
- have at least one smartphone running Android 5.0 or higher or iOS 12.0 or higher connected to the internet and able to receive CGM data available to them on the day of the inclusion,
- able to read or use a smartphone with no visual impairment needing specific typography,
- for patients of childbearing potential, a pregnancy test must have been carried out prior to inclusion, or an effective and adequate method of contraception must be used,
- be affiliated to a French social security scheme.
- pregnant or breast-feeding women,
- type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors),
- insulin-resistant patient: prescribed daily insulin dose \> 1 U/kg/day or \> 200 U/day,
- patient with very low insulin requirements: daily insulin dose \< 15 U/day,
- patient with gastroparesis,
- diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion,
- pancreatic disease secondary to chronic ethanolism,
- known medical condition that, in the investigator's opinion, may interfere with the protocol,
- patient who cannot be monitored for 3 months,
- intellectual ability compromising use of the application, comprehension or completion of questionnaires,
- participation in another clinical trial or administration of a non-authorised drug in the 4 weeks preceding the screening,
- person taking part in another research study with an exclusion period still in progress,
- under guardianship or curatorship,
- imprisoned or otherwise deprived of liberty.
The study team makes the final eligibility decision.
Where it's taking place
- Bobigny, France
- Caen, France
- Chartres, France
- Corbeil-Essonnes, France
- Dijon, France
- Le Havre, France
- Limoges, France
- Marseille, France
- Mérignac, France
- Montpellier, France
- Paris, France
- Périgueux, France
- Saint-Cyr-sur-Loire, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bobigny, France; Caen, France; Chartres, France; Corbeil-Essonnes, France; Dijon, France; Le Havre, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.