Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-IQ System | Participants will use the Control-IQ System as per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) | Device | Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of diabetic ketoacidosis (DKA). | The incidence rate of diabetic ketoacidosis (DKA) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years. | 12 months |
| Rate of severe hypoglycemia (SH) | The incidence rate of severe hypoglycemia (SH) will be calculated by dividing the total number of events observed in the entire cohort over the 12-month follow-up period. Results will be expressed as the number of events per 100 patient-years. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range 70-180 mg/dL (TIR) | The change in (%) time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 12 months. | 12 months |
| Time above 180 mg/dL |
Not provided
Inclusion Criteria:
Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.
Age ≥ 6 years at enrollment.
Using an insulin approved for use in the pump.
Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
Reside full-time in mainland France.
Have an email address and mobile phone number
Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :
Exclusion Criteria:
Not provided
Not provided
Not provided
All individuals with Type 1 Diabetes age 6+, who start therapy with the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or Dexcom G7 and meet eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur Senigout | Contact | +33 6 85 98 40 44 | record-iq@sanoia.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Riveline, MD, PhD | Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Agen-Nérac | Recruiting | Agen | 47923 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The change in (%) time spent above 180 mg/dL, defined as the proportion of sensor glucose concentration above 180 mg/dL, between baseline and 12 months.
| 12 months |
| Time above 250 mg/dL | The change in (%) time spent above 250 mg/dL, defined as the proportion of sensor glucose concentration above 250 mg/dL, between baseline and 12 months. | 12 months |
| Time less than 70 mg/dL | The change in (%) time spent less than 70 mg/dL, defined as the proportion of sensor glucose concentration less than 70 mg/dL, between baseline and 12 months. | 12 months |
| Time less than 54 mg/dL | The change in (%) time spent less than 54 mg/dL, defined as the proportion of sensor glucose concentration less than 54 mg/dL, between baseline and 12 months. | 12 months |
| Treatment Satisfaction | To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months. | 12 months |
| System Usability | To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months. | 12 months |
| Quality of Life Change | To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months. | 12 months |
| Fear of Hypoglycemic Events Change | To evaluate change in fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) from baseline through 12 months. | 12 months |
| Rate of use of the system | To determine the rate of use of the system as established by % time in closed-loop, from baseline through 12 months. | 12 months |
| CHU d'Angers | Recruiting | Angers | 49100 | France |
|
| CHU Lyon HFME | Recruiting | Bron | 69677 | France |
|
| Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL) | Recruiting | Lyon | 69003 | France |
|
| Hôpital Européen (APHM) | Recruiting | Marseille | 13003 | France |
|
| GHEF Meaux | Recruiting | Meaux | 77100 | France |
|
| CHR Metz-Thionville | Recruiting | Metz | 57000 | France |
|
| CHU de Montpellier | Recruiting | Montpellier | 34090 | France |
|
| Clinique Saint Jean de Védas | Recruiting | Montpellier | 34430 | France |
|
| CHU Nîmes | Recruiting | Nîmes | 30029 | France |
|
| Institut St-Pierre | Recruiting | Palavas-les-Flots | 34250 | France |
|
| Hôpital Lariboisière | Recruiting | Paris | 75010 | France |
|
| Hôpital St-Antoine (APHP) | Recruiting | Paris | 75012 | France |
|
| GH Paris Saint-Joseph | Recruiting | Paris | 75014 | France |
|
| Hôpital Européen Georges Pompidou (APHP) | Recruiting | Paris | 75015 | France |
|
| Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
|
| CH de Périgueux | Recruiting | Périgueux | 24000 | France |
|
| MSP Les Belles Fleurs | Recruiting | Saint-Cyr-sur-Loire | 37540 | France |
|
| Clinique Pasteur Toulouse | Recruiting | Toulouse | 31300 | France |
|
| CHU Toulouse | Recruiting | Toulouse | 31403 | France |
|
| CHU Tours | Recruiting | Tours | 37000 | France |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided