Diabetes Mellitus, Type 1 Clinical Trial
— BETTEROfficial title:
Interventional Before/After Study of the Effect of the DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump on Glucose Control of Patients With Type 1 Diabetes in France. The BETTER Trial
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62. After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system. The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes. Data related to their glycemia, complications, usability and quality of life will be collected. The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | March 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject who is at least 18 years old, 2. The total daily dose required must be less than 90 units (U), 3. Subject accepting to be treated with 100 U/mL rapid-acting insulin analog, 4. Type 1 diabetes treated for at least 6 months (Patients treated by manual injection with insulin pen - MDI - or by competitor open loop systems or former closed loop patients if they stopped the closed loop system > 3 months before inclusion) with a stable insulin therapy regimen for at least 15 days, 5. HbA1c = 10%, 6. Subject must be affiliated to any kind of social security, 7. Living in an area covered by a GSM (Global System for Mobile Communications) network, 8. Non-isolated patient, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home, 9. Must be able to speak and be literate in French, 10. Having signed the free and informed consent form Exclusion Criteria: 1. Subject receiving a total daily dose of insulin below 8 U, 2. Subject suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids), 3. Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity, 4. Subject unable to understand and perform instructions provided by Diabeloop SA, 5. Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period, 6. Subject who is unwilling or unable to maintain contact with the healthcare professional, 7. Subject using a pacemaker. There is the risk of this device adversely affecting pacemakers and causing them to malfunction, 8. Subject is unable to tolerate tape adhesive around the sensor or pump placements, 9. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection), 10. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of inclusion visit, or plans to take any oral, injectable, or IV steroids during the study, 11. Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks, 12. Subject is using DPP-4 inhibitor, GLP-1 agonists, metformin, a-glucosidase inhibitors, thiazolidinediones and/or other SGLT2 inhibitors at time of screening, 13. Diagnosed with chronic kidney disease (glomerular filtration < 30 mL/min or Serum creatinine > 176 µmol/L), 14. Patient who has had a pancreatectomy or who has pancreatic malfunctions or pancreatic islet transplantation or pancreas transplantation, 15. Patient on dialysis, 16. Patient with impaired hepatic functions, 17. Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator, 18. Pregnant woman or woman of childbearing potential in the absence of an effective method of contraception or if she does not agree to continue using contraception for the duration of the study, 19. Patient under legal protection (curatorship) |
Country | Name | City | State |
---|---|---|---|
France | CH Sud Francilien | Corbeil-Essonnes | |
France | CHU Grenoble | Grenoble | |
France | Groupe Hospitalier La Rochelle - Ré - Aunis | La Rochelle | |
France | CHU Lille - Hôpital Huriez | Lille | |
France | Centre du diabète DIAB-eCARE - HCL | Lyon | |
France | Hôpital la Conception - APHM | Marseille | |
France | Hôpital Nord Laennec | Nantes | |
France | CHU Rennes Pontchaillou | Rennes | |
France | CHRU de Strasbourg - Hôpital Civil | Strasbourg | |
France | CHU Toulouse - Hôpital de Rangueil | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Diabeloop | Icadom |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time spent in 70 - 180 mg/dL glycemic range | Impact of the use of DBLG1 system on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage. | 56 days | |
Secondary | Percentage of time spent in specific glycemic ranges | Impact of the use of DBLG1 system on the time spent: < 54 mg/dL, 54-69 mg/dL, < 70 mg/dL, 70-140 mg/dL, 70-180 mg/dL (for extension period), 181-250 mg/dL, > 250 mg/dL during the main treatment period compared to baseline, and during the extension period compared to baseline, in percentage. |
98 days | |
Secondary | Incidence of severe hypoglycemia | Severe hypoglycemia is defined as hypoglycemia requiring third-party intervention OR with loss of consciousness OR involving hospitalization. The number of episodes, the number of patients with at least one episode (and percentage) will be described per study period and overall |
98 days | |
Secondary | Incidence of severe hyperglycemia | Severe hyperglycemia is defined as hyperglycemia with occurrence of ketoacidosis above 3 mmol/L OR involving hospitalization. The number of episodes, the number of patients with at least one episode (and percentage) will be described per study period and overall | 98 days | |
Secondary | Number of adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated serious adverse device effects | The number of events, number of patients with at least one event (and percentage) will be described for the following type de AEs: Adverse Events (AEs) Serious Adverse Events (SAEs) Adverse Device Effects (ADEs) Serious adverse Device Effects (SADEs) Unanticipated Serious adverse Device Effects (USADEs) Description will be provided overall and per study periods. |
98 days | |
Secondary | Evolution of HbA1c measured by blood sampling for patients participating in extension study phase | Impact of the use of DBLG1 system on the evolution of HbA1c measured at baseline and after the extension period. | 98 days | |
Secondary | Glucose management indicator (GMI) | Impact of the use of DBLG1 system on the Glucose management indicator (GMI) during the main treatment period compared to baseline, and during the extension period compared to baseline. The formula used to calculate GMI is: GMI(%) = 3.31 + 0.02392 x [mean glucose in mg/dL]. | 98 days | |
Secondary | Average sensor glucose level | Impact of the use of DBLG1 system on mean CGM records during the main treatment period compared to baseline, and during the extension period compared to baseline. | 98 days | |
Secondary | Variability of the glucose level | Impact of the use of DBLG1 system on the variability of the glucose level measured by the glycemic variation coefficient (CV) and Standard Deviation (SD) intra patient during the main treatment period compared to baseline, and during the extension period compared to baseline. | 98 days | |
Secondary | Average dose of insulin used during the entire study | The average sensor glucose level is calculated per patient as the average of all its CGM records over a study period. | 98 days | |
Secondary | Percentage of time spent in closed loop mode | For both study and extension closed loop period, the percentage of time spent with close loop mode on will be calculated as the number of CGM records under close loop over the number of possible CGM records during the period. This endpoint will be described overall and per period concerned. | 98 days | |
Secondary | Percentage of days with >75% closed loop records | For both study and extension closed loop period, the percentage of days with >75% closed loop records will be described as a quantitative parameter. | 98 days | |
Secondary | Diabetes Treatment Satisfaction (DTSQs) Questionnaire items | The 8 DTSQ questionnaire items will be described as qualitative and quantitative outcomes at baseline, treatment and extension period. The minimum and maximum scores per item are 0 and 6, respectively. The higher the score, the more satisfied the patient is with the treatment. The evolution in score will be compared. |
98 days | |
Secondary | Scoring of Diabetes Treatment Satisfaction (DTSQs) Questionnaire | The DTSQ score is the sum of the 8 questionnaire items. It has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with the treatment. DTSQ score will be described as continuous parameters at baseline, treatment and extension period. The evolution in score will be compared. |
98 days | |
Secondary | Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire total score | The Hypoglycemia Fear Survey (HFS) II questionnaire consists of 33 items. The HFS II score has a minimum of 0 and a maximum of 132. The higher the score, the more the patient fears hypoglycemia. The total score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared. | 98 days | |
Secondary | Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Behaviour scale | The 15 items in Hypoglycemia Fear Survey (HFS-B) Behavior scale measure behaviors aimed at avoiding hypoglycemia and its possible negative consequences. The HFS-B score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared. The score has a minimum of 0 and a maximum of 60. The higher the score, the more the patient fears hypoglycemia. | 98 days | |
Secondary | Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Worrieness scale | The 18 items in Hypoglycemia Fear Survey (HFS-W) Worriedness scale measure various aspects relating to hypoglycemic episodes that provoke anxiety. The HFS-W score will be described as continuous parameters at baseline and at end of study. The evolution in score will be compared. The score has a minimum of 0 and a maximum of 72. The higher the score, the more the patient fears hypoglycemia. |
98 days | |
Secondary | Scoring of Diabetes Distress Scale (DDS) | The 17 items of DDS will be described both as continuous and categorical variables at baseline, treatment and extension period. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem". Average scores will be computed and described for the four critical dimensions of distress: emotional burden, regimen distress, interpersonal distress and physician distress. The minimum and maximum scores will be 1 and 6, respectively. The evolution in DDS average score will be compared. |
98 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT03605329 -
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Recruiting |
NCT06050642 -
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
|
N/A | |
Completed |
NCT05107544 -
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT04443153 -
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
|
N/A | |
Completed |
NCT04569994 -
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
|
Phase 1 | |
Completed |
NCT04521634 -
Glycaemic Variability in Acute Stroke
|
||
Completed |
NCT04089462 -
Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
|
N/A | |
Completed |
NCT03143816 -
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
Phase 4 | |
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
Completed |
NCT04042207 -
Diabeloop for Highly Unstable Type 1 Diabetes
|
N/A | |
Not yet recruiting |
NCT06068205 -
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
|
||
Recruiting |
NCT05909800 -
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
|
Phase 2 | |
Active, not recruiting |
NCT04974528 -
Afrezza® INHALE-1 Study in Pediatrics
|
Phase 3 | |
Completed |
NCT04530292 -
Home Intervention and Social Precariousness in Childhood Diabetes
|
N/A | |
Completed |
NCT05428943 -
OPT101 in Type 1 Diabetes Patients
|
Phase 1 | |
Recruiting |
NCT03988764 -
Monogenic Diabetes Misdiagnosed as Type 1
|
||
Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A |