Diabetes Mellitus, Type 2 Clinical Trial
— SERENIT2Official title:
Multicentric Before/After Study to Assess the Efficacy and Safety of DBL-4pen Mobile Application on Glycemic Control in Patients With Type 2 Diabetes
This study conducted in 40 adults living with type 2 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), the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps, in addition to the Dexcom G6 CGM. An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application. The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes. Data related to efficacy of DBL-4pen, global safety of DBL-4pen, compliance with recommended insulin injections, satisfaction with the system 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 | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: Device-related inclusion criteria: - Patients under basal-bolus scheme for type 2 diabetes - Patients aged = 18 years old - Patients using rapid-acting analog and long-acting analog that are compatible with Mallya cap (Lispro, Detemir, Aspart, Glargine, Glulisine) with a stable insulin therapy regimen for at least the past 90 days (no modification of the number of injections and no more than 10% variation of the total daily dose) - Patients using insulin with a concentration 100 U/mL Study-specific inclusion criteria: - No significant modification of diabetes treatment during the 3 months before inclusion (i.e., no introduction or removal of any pharmacological treatment, and no education training during this period), except for a possible modification for an equivalent insulin compatible with Mallya at least 15 days before inclusion - Patients having an HbA1c = 10% - Patients who agree to use Dexcom G6 as CGM - Patients living in an area covered by phone network - Patients must be affiliated to any kind of social security - Patients must be able to speak and be literate in French - Non-isolated patients, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home - Having signed the free and informed consent form - Subject equipped with a CGM for at least the past 90 days Non-inclusion criteria Device-related non-inclusion criteria - Patients with Total Daily Dose (TDD) < 10 U - Patients 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). - Patients with severe uncorrected hearing impairment and/or severe uncorrected proble- ms of visual acuity. - Patients unable to understand and perform instructions provided by Diabeloop SA. - Patients who are unwilling or unable to maintain contact with the healthcare professional. - Use of any insulin that is not 100U/mL rapid-acting insulin analog, 100U/mL long-acting insulin analog. Study-specific non-inclusion criteria: - Patients with type 1 diabetes - Patients not feeling hypoglycemia (hypoglycemia unawareness) - Patients who had an episode of severe hypoglycemia or a hypoglycemic coma in the past year while being equipped with any glucose sensor - Patients not accepting to stay in France during the study - Pregnant woman (verified by urine HCG pregnancy test for any woman wishing to participate in the protocol and of childbearing age < 60 year) 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 - Subjects under legal protection (guardianship, curatorship) - Patients whose pancreas has been removed or is not functioning altogether - Patients with islet/pancreas transplants. - Patients with severely altered renal function (creatinine clearance <30 mL/min). - Patients on dialysis - Critically ill patients - 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. |
Country | Name | City | State |
---|---|---|---|
France | CH Sud Francilien | Corbeil-Essonnes | |
France | CHU Grenoble | Grenoble | |
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 DBL-4pen 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 DBL-4pen 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) > 180 mg/dL 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 | Mean CGM glycemia | Impact of the use of DBL-4pen 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 DBL-4pen 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 | Glucose management indicator (GMI) | Impact of the use of DBL-4pen 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 | Evolution of HbA1c for patients accepting the extension phase | Impact of the use of DBL-4pen on the evolution of HbA1c measured at baseline and after the extension period. | 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 patients with severe hypoglycemia (and percentage) and the number of hypoglycemia events per week will be described overall and per study period. |
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 events per week, 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 of adverse events: Adverse Events (AEs) Serious Adverse Events (SAEs) Adverse Device Effects (ADEs) Serious adverse Device Effects (SADEs) Unanticipated Serious adverse Device Effects (USADEs) |
98 days | |
Secondary | Difference between the number of boluses recommended by the application and the number of boluses administered by the patient | The number of boluses recommended, administered per patient and the difference will be described per day for treatment and extension period. A recommended bolus is defined as an alert corresponding to a bolus recommendation (correction bolus and meal bolus recommendations). The potential factors associated with the difference between the number of boluses recommended by the application and administered by the patient will be investigated. |
98 days | |
Secondary | Difference between recommended and administered insulin dose | The total insulin dose per day and per patient will be described as a continuous parameter for treatment and extension period for recommended insulin and administered insulin. The difference between recommended and administered insulin dose will be described as absolute value and as the percentage of the recommended dose. | 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.The change in DDS will be evaluated between treatment and baseline period and between extension and baseline period. |
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. The evolution in score will be compared. |
98 days |
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