Continuous Glucose Monitoring System, Diabetes Distress, Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 1, Diabetes Mellitus ( Type 1 and Type 2), Diabetes Mellitus Type 2, Ecological Momentary Assessment, Fear of Hypoglycemia, Glucose Control, Glycemic Responses, Glycemic Variability, Prediction, Sleep Quality
Conditions
Keywords
Accu-Chek SmartGuide CGM, Predict App solution, Diabetes Mellitus, Fear of Hypoglycemia, Continuous glucose monitoring system
Brief summary
The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.
Detailed description
Continuous glucose monitoring (CGM) is widely used by people with insulin- treated diabetes to monitor glucose levels and support daily diabetes management. The Accu-Chek SmartGuide CGM system provides continuous glucose measurements and includes predictive features that are intended to provide information about possible future glucose trends. This study will investigate the use of the Accu-Chek SmartGuide with and without these predictive features in adults with type 1 diabetes or type 2 diabetes treated with intensified insulin therapy. The study will be conducted remotely in Germany through the dia\*link online panel. No in-person study visits are planned. Participants will use the Accu-Chek SmartGuide CGM system for a total of 6 weeks. The study consists of two consecutive phases. During the first 2 weeks, participants will use the Accu-Chek SmartGuide CGM without the Predict App and therefore without the predictive features. This phase provides a period in which CGM data and self-reported outcomes can be assessed before the predictive features are introduced. After 2 weeks, participants will receive training on the Predict App and begin a 4-week period using the Accu-Chek SmartGuide together with the Predict App. Participants will complete online questionnaires at the end of the first 2 weeks and at the end of the 6-week study period. The questionnaires assess fear of hypoglycemia, sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment. During the first 2 weeks and the last 2 weeks of the study, participants will also complete short ecological momentary assessment (EMA) questionnaires twice daily using a smartphone app. The morning assessment asks about sleep quality and confidence in preventing hypoglycemia. The evening assessment asks about the use and evaluation of CGM functions, including trend arrows, alarms, and predictive features. Participants will also be asked about possible therapy adjustments, satisfaction with the CGM functions, and diabetes- related distress, including distress related to hypoglycemia, hyperglycemia, and glucose variability. CGM data will be collected throughout both study phases. These data will include measures such as time in glucose ranges, hypoglycemia, hyperglycemia, glucose variability, and mean glucose levels. The study will assess changes in these measures between the two study phases. The primary outcome is the change in fear of hypoglycemia during the 4-week period in which participants use the Accu-Chek SmartGuide together with the Predict App. Secondary outcomes include changes in other psychosocial outcomes, diabetes-related behaviors, use and evaluation of CGM alarms and trend arrows, and CGM-derived glucose measures. In addition, a subgroup of 10 participants will be invited to take part in a semi-structured online interview after completing the study. The interviews will explore participants' experiences with the predictive features, their confidence and trust in these features, perceived benefits in everyday diabetes management, and suggestions for improvement. Participants will be selected to achieve a balanced representation with regard to age, sex, and type of diabetes.
Interventions
DEVICESmartGuide CGM without Predict App
SmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function
DEVICESmartGuide CGM with Predict App
SmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function
Sponsors
FIDAM RDC
Roche Diabetes Care
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes or Type 2 diabetes with intensified insulin therapy (defined as basal-bolus therapy with self-adjustment of bolus doses) * CGM use during the past 3 months (without predictive features) * Age ≥ 18 years * HbA1c \< 10% * Informed consent
Exclusion criteria
* Use of the SmartGuide CGM solution * AID use * Current treatment with psychiatric medications * Diabetes duration \< 3 months * Current or planned pregnancy * Peripheral neuropathy that will impact sleep quality according to the judgement of the participant * Severe complications (e.g. kidney disease, cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of hypoglycemia (HFS-II) | At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline) | Within-person change in fear of hypoglycemia from baseline to follow-up, assessed via the Hypoglycemia-Fear Survey II questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall sleep quality (PSQI) | At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline) | Changes will be analyzed using a questionnaire |
| Hypoglycemia confidence (HCS) | At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline) | Changes will be analyzed using a questionnaire |
| Diabetes distress (DDS) | At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline) | Changes will be analyzed using a questionnaire: Diabetes distress (DDS: total score + subscale scores), Hypoglycemia-related distress, Powerlessness |
| Diabetes Empowerment (DES-SF) | At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline) | Changes will be analyzed using a questionnaire |
| Daily sleep quality | 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening) | Changes will be analyzed on a daily level using Ecological Momentary Assessment (EMA) |
| Avoidance of hypos | 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening) | Changes will be analyzed on a daily level using Ecological Momentary Assessment (EMA) |
| Time with diabetes and glycemic-specific distress | 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening) | Changes will be analyzed on a daily level using Ecological Momentary Assessment (EMA) |
| Changes in behavior | 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening) | Use of and reaction to trend arrows, Use of and reaction to glucose alarms, Settings of glucose alarms, Use of and reaction to predictive features |
| Changes in glycemic outcomes | From enrollment to the end of the study at 6 weeks | % 70-180 mg/dl, % 70-140 mg/dl, % \< 70 mg/dl, % \> 180 mg/dl, % \< 54 mg/dl, % \> 250 mg/dl, Glucose variability (Coefficient of variation), Mean glucose |
| Personal experiences | After the study period of 6 weeks | Qualitative interviews to gain deeper insights into the personal experiences, expectations, handling, perceived advantages and disadvantages, wishes, etc. of users |
Countries
Germany
Contacts
CONTACTDominic Ehrmann, Prof. Dr.
Outcome results
None listed