Diabetes Mellitus Type 1, Fear of Hypoglycemia, Glucose Metabolism Disorder, Glycemic Control for Diabetes Mellitus, Hypoglycaemia, Quality of Life, Treatment Satisfaction
Conditions
Keywords
Automated insulin delivery, Exercice, Diabetes Mellitus, Type 1, Hypoglycemia, Glycemic control
Brief summary
This is a non-interventional, prospective, multi-site study conducted in France among adults with type 1 diabetes mellitus using automated insulin delivery (AID) systems and engaging in at least two exercise sessions per week, each lasting at least 30 minutes. The main objective of this study is to describe the glycemic control of athletic participants with type 1 diabetes mellitus who use an insulin pump with AID and engage in physical exercise under real-life conditions. Two physician data collection time points are planned: the first occurs at baseline and includes demographic and clinical data, glycemic control during the month preceding inclusion, diabetes management, and information on usual physical exercise (duration, type, sport practiced, competition participation, and adherence to a specific diet). The second occurs at 1-month follow-up and involves downloading insulin pump and glucose sensor data, covering the period from 15 days before the first reported exercise session to 15 days after the last session. During the 1-month study period, participants will complete a paper logbook after each exercise session to document information such as the type of exercise, self-reported intensity using the modified Borg scale and the WHO physical activity intensity scale, duration, system adjustments, dietary intake, occurrence of hypoglycemia and associated symptoms, snacks consumed, and treatments administered for hypoglycemia.
Detailed description
Three hybrid closed-loop systems dedicated to the automated management of type 1 diabetes are currently available in France: the Minimed 780G paired with the Guardian 4 continuous glucose monitoring system, Control-IQ, and mylife CamAPS-FX. Stratification will be performed based on the type of pump used by participants at the time of inclusion, at the national level, in order to obtain groups balanced in size.
Interventions
OTHERNo Intervention: Observational Cohort
No intervention
Sponsors
ISIS Diabete Service
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants with diabetes mellitus type 1 * User for at least 3 months of one the three automated insulin delivery systems available in France at the time of the study (Minimed 780G pump + Guardian 4 sensor + PID-IFB algorithm; or T:Slim X2 pump + Dexcom G6 sensor + Control-IQ algorithm; or mylife Ypsopump + Dexcom G6 sensor + CamAPS FX app) * Engaged in regular physical activity as part of daily life (at least 2 structured sessions per week, each lasting more than 30 minutes) * Able to download data from the pump * Willing and able to complete the physical activity log and self-questionnaires in French * Having received the information sheet and given their oral consent (non-opposition) to participate in the study and for their data processing
Exclusion criteria
* Participants currently enrolled in a clinical trial * Pregnancy or breastfeeding women or women planning a pregnancy during the study * Adults under legal protection (guardianship, curatorship, or judicial safeguard) * Participants with decompensated retinopathy * Participants with decompensated cardiac disease * History of severe hypoglycemia during physical activity in the past 6 months * Participants with unresolved diabetic foot trophic disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Below Range | One month | Percentage of time spent with glucose \<70 mg/dL and \<54 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Above Range | One month | Percentage of time spent with glucose \>180 mg/dL and \>250 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods |
| Time-in-Range | One month | Percentage of time spent in target glucose range 70-180 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods |
| ADDQoL questionnaire | At inclusion | Self-administered questionnaire: Audit of Diabetes-Dependent Quality of Life (ADDQoL), including three scores: The first concerns the perceived quality of life, with 7 items ranging from "extremely poor" to "excellent." Total scores range from -3 to +3, with higher scores reflecting better quality of life. The second concerns the quality of life if the participant did not have diabetes, with 5 items ranging from "much better" to "worse." Total scores range from -3 to +1, with higher scores indicating that life would be significantly worse without diabetes. The third concerns the impact of diabetes on specific life domains, with 19 items ranging from "much better" to "worse," combined with the personal importance of each domain, rated from 0 (not at all important) to 3 (very important). The resulting weighted ADDQoL scores range from -9 to +3, with higher scores reflecting the maximum positive impact of diabetes. |
| DTSQs questionnaire | At inclusion | Self-administered questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQs), consisting of 8 items ranging from 0 to 6. Total scores range from 0 to 36, with higher scores indicating better treatment satisfaction. |
| HFS-II questionnaire | At inclusion | Self-administered questionnaire Hypoglycemia Fear Survey II (HFS-II) composed of two subscales: a Behaviour score and a Worry score, each consisting of 4 items rated from 0 (never) to 4 (almost always). Total scores range from 0 to 16 with higher scores reflecting greater behavioural or emotional impact. |
| Ajustement Practices | One month | Reported by participants and available from insulin pump data before, during and after exercise sessions |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORBruno GUERCI, Professor, MD, PhD
CHRU Nancy and University of Lorraine, Nancy, france
Outcome results
None listed