Diabetes Mellitus, Type 1
Conditions
Keywords
Control-IQ, t:slim X2 insulin pump, Control-IQ technology, DKA, severe hypoglycemia, automated insulin dosing, automated insulin delivery, quality of life, type 1 diabetes
Brief summary
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.
Detailed description
This post-market surveillance study is a single-arm, prospective cohort study. It is designed to: 1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis). 2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation. 3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life. 4. Describe the real-world use of the Control-IQ System.
Interventions
DEVICEt:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
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.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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 : 1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment. 2. the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months. 3. complete questionnaires per the study protocol.
Exclusion criteria
* A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study. * Patients considered vulnerable under French law.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of diabetic ketoacidosis (DKA). | 12 months | 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. |
| Rate of severe hypoglycemia (SH) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range 70-180 mg/dL (TIR) | 12 months | 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. |
| Time above 180 mg/dL | 12 months | 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. |
| Time above 250 mg/dL | 12 months | 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. |
| Time less than 70 mg/dL | 12 months | 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. |
| Time less than 54 mg/dL | 12 months | 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. |
| Treatment Satisfaction | 12 months | To evaluate treatment satisfaction based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores at baseline through 12 months. |
| System Usability | 12 months | To evaluate treatment satisfaction based on the System Usability Scale (SUS) scores at baseline through 12 months. |
| Quality of Life Change | 12 months | To evaluate change in quality of life based on the EQ-5D scores at baseline through 12 months. |
| Fear of Hypoglycemic Events Change | 12 months | To evaluate change in fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS) from baseline through 12 months. |
| Rate of use of the system | 12 months | To determine the rate of use of the system as established by % time in closed-loop, from baseline through 12 months. |
Countries
France
Contacts
CONTACTArthur Senigout
PRINCIPAL_INVESTIGATORJean-Pierre Riveline, MD, PhD
Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France
Outcome results
None listed