Diabetes (DM)NCT07814508
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
A study testing SmartGuide CGM with Predictive Features in people with Diabetes (DM) and Diabetes Mellitus, run by FIDAM RDC at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 2
- What is being tested?
- SmartGuide CGM with Predictive Features
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fidam Rdc
Bad Mergentheim, Baden-Wurttemberg, 97980
Dominic Ehrmann, Prof. Dr., +49 7931 96192 42, ehrmann@fidam.de
About this study
Official title: Changes in Person-reported Outcomes and Behavior Due to a Predictive Algorithm: A Pre-post Trial With the Accu-Chek SmartGuide CGM and the Predict App Solution
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:
Read more
- 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.
Read the 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.
- Conditions
- Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Diabetes Mellitus ( Type 1 and Type 2), Fear of Hypoglycemia
- Being tested
- SmartGuide CGM with Predictive Features
- Keywords
- Accu-Chek SmartGuide CGM, Predict App solution, Diabetes Mellitus, Fear of Hypoglycemia, Continuous glucose monitoring system
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartGuide CGM with Predictive FeaturesDevice
Also called continuous glucose monitoring with predictive algorithm, CGM with predictive algorithm, Accu-Check SmartGuide CGM and Predict App
All participants use Accu-Check SmartGuide continuous glucose monitoring (CGM) without predictive features during the first 2 weeks, followed by 4 weeks of CGM use with predictive features enabled.
| Study group | Role | What they receive |
|---|---|---|
| SmartGuide CGM with Predictive Features | Experimental | All participants use continuous glucose monitoring (CGM) without predictive features during the first 2 weeks, followed by 4 weeks of CGM use with predictive features enabled. Receives: Device: SmartGuide CGM with Predictive Features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hypoglycemia Fear Survey II (HFS-II) Total Score from Baseline to Follow-up
Within-person change in fear of hypoglycemia from baseline to follow-up, assessed using the Hypoglycemia Fear Survey II (HFS-II), a 33-item questionnaire measuring behaviors related to avoiding hypoglycemia and worries about hypoglycemia and its consequences. Total scores range from 0 to 132, with higher scores indicating greater fear of hypoglycemia.
Measured: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Secondary outcomes (12)
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score from Baseline to Follow-up
Change in overall sleep quality from baseline to follow-up, assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire assessing sleep quality and disturbances over the previous month. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Hypoglycemic Confidence Scale (HCS) Mean Score from Baseline to Follow-up
Change in confidence in preventing and managing hypoglycemia from baseline to follow-up, assessed using the Hypoglycemic Confidence Scale (HCS), a 9-item self-report questionnaire assessing confidence in staying safe from hypoglycemia-related problems. The mean scores range from 1 to 4, with higher scores indicating greater confidence.
Measured: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Diabetes Distress Scale (DDS-17) Mean Score from Baseline to Follow-up
Change in diabetes distress from baseline to follow-up, assessed using the 17-item Diabetes Distress Scale (DDS-17), a self-report questionnaire assessing diabetes-related emotional burden, regimen-related distress, physician-related distress, and interpersonal distress. The mean score ranges from 1 to 6, with higher scores indicating greater diabetes distress.
Measured: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Diabetes Empowerment Scale-Short Form (DES-SF) Mean Score from Baseline to Follow-up
Change in diabetes-related empowerment from baseline to follow-up, assessed using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), a self-report questionnaire assessing psychosocial self-efficacy in diabetes self-management. Mean scores range from 1 to 5, with higher scores indicating greater diabetes-related empowerment.
Measured: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Changes in Daily Sleep Quality Assessed by Ecological Momentary Assessment (EMA)
Daily subjective sleep quality will be assessed using ecological momentary assessment (EMA) on a 0-3 rating scale with one prompt per day in the morning. Higher scores indicate better sleep quality. Changes in sleep quality will be analyzed at the daily level across the assessment periods.
Measured: 14 days after enrollment and 14 days before study end with one prompt per day (morning)
Changes in Daily Fear of Hypoglycemia Assessed by Ecological Momentary Assessment (EMA)
Fear of hypoglycemia will be assessed using ecological momentary assessment (EMA) on a 0-10 rating scale with one prompt per day in the morning. Higher scores indicate reduced fear of hypoglycemia. Changes in scores will be analyzed at the daily level across the assessment periods.
Measured: 14 days after enrollment and 14 days before study end with one prompt per day (morning)
Changes in Daily Diabetes- and Glycemic-specific Distress Assessed by Ecological Momentary Assessment (EMA)
Diabetes and glycemic-specific distress will be assessed using ecological momentary assessment (EMA) on a 0-10 rating scale with one prompt per day in the evening. Higher scores indicate higher distress. Changes in scores will be analyzed at the daily level across the assessment periods.
Measured: 14 days after enrollment and 14 days before study end with one prompt per day (evening)
Change in Daily Use of and Responses to Continuous Glucose Monitoring (CGM) Features
Use of and responses to CGM features will be assessed using ecological momentary assessment (EMA). Assessments will cover the use of and responses to glucose trend arrows, the use of and responses to glucose alarms, glucose alarm settings, and the use of and responses to predictive features. Changes in these behaviors will be analyzed across the assessment periods.
Measured: 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening)
Changes in Time in, Above, and Below Glucose Range
Changes in Glycemic outcomes across the assessment period will be assessed using continuous glucose monitoring (CGM) data and expressed as the percentage of time spent in the following glucose ranges: 70-180 mg/dL (time in range), 70-140 mg/dL, below 70 mg/dL, below 54 mg/dL, above 180 mg/dL, and above 250 mg/dL.
Measured: From enrollment to the end of the study at 6 weeks
Changes in Glucose Variability (Coefficient of Variation)
Changes in Glucose variability (%) across the assessment period will be assessed using continuous glucose monitoring (CGM) data and expressed as the coefficient of variation (CV), calculated as the standard deviation of glucose levels divided by the mean glucose level, multiplied by 100.
Measured: From enrollment to the end of the study at 6 weeks
Changes in Mean Glucose
Changes in mean glucose concentration will be assessed using continuous glucose monitoring (CGM) data and reported in mg/dL.
Measured: From enrollment to the end of the study at 6 weeks
Participants' Experiences with CGM Predictive Features
Qualitative interviews will be conducted at the end of the study to explore participants' personal experiences, expectations, and experiences using the continuous glucose monitoring (CGM) system and its predictive features. Topics will include perceived benefits and disadvantages, experiences with handling the features, expectations, and suggestions or wishes for future improvements.
Measured: After the study period of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Feb 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FIDAM RDC
- Sponsor type
- Research network
- Collaborators
- Roche Diabetes Care
- Responsible party
- Principal investigator, Dominic Ehrmann, FIDAM RDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814508
- Sponsor's protocol ID
- FIDAM-IIS-2501
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ehrmann D, Laviola L, Priesterroth LS, Hermanns N, Babion N, Glatzer T. Fear of Hypoglycemia and Diabetes Distress: Expected Reduction by Glucose Prediction. J Diabetes Sci Technol. 2024 Sep;18(5):1027-1034. doi: 10.1177/19322968241267886. Epub 2024 Aug 19.
PubMed 39158974Glatzer T, Ehrmann D, Gehr B, Penalba Martinez MT, Onvlee J, Bucklar G, Hofer M, Stangs M, Wolf N. Clinical Usage and Potential Benefits of a Continuous Glucose Monitoring Predict App. J Diabetes Sci Technol. 2024 Sep;18(5):1009-1013. doi: 10.1177/19322968241268353. Epub 2024 Aug 19.
PubMed 39158995Hussain S, Polonsky W, Scibilia R, Glatzer T. Beyond the Trend Arrow: Potential Value of Artificial Intelligence-Supported Glucose Predictions for People with Type 1 Diabetes Using Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2025 Nov;27(11):943-949. doi: 10.1089/dia.2025.0293. Epub 2025 May 29.
PubMed 40441551
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Person-reported Outcomes and Behavior Due to a Predictive Algorithm: A Pre-post Trial With the Accu-Chek SmartGuide CGM and the Predict App Solution
- ClinicalTrials.gov ID
- NCT07814508
- Acronym / sponsor ID
- FIDAM-IIS-2501
- Conditions
- Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Diabetes Mellitus ( Type 1 and Type 2), Fear of Hypoglycemia
- Keywords
- Accu-Chek SmartGuide CGM, Predict App solution, Diabetes Mellitus, Fear of Hypoglycemia, Continuous glucose monitoring system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- FIDAM RDCResearch network
- Collaborators
- Roche Diabetes Care
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartGuide CGM with Predictive Features | Experimental | Device: SmartGuide CGM with Predictive FeaturesAll participants use continuous glucose monitoring (CGM) without predictive features during the first 2 weeks, followed by 4 weeks of CGM use with predictive features enabled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Use of the SmartGuide CGM solution
- AID use
- Current treatment with psychiatric medications
- Diabetes duration < 3 months
- Current or planned pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartGuide CGM with Predictive FeaturesAlso: continuous glucose monitoring with predictive algorithm, CGM with predictive algorithm, Accu-Check SmartGuide CGM and Predict AppAll participants use Accu-Check SmartGuide continuous glucose monitoring (CGM) without predictive features during the first 2 weeks, followed by 4 weeks of CGM use with predictive features enabled. | Device | SmartGuide CGM with Predictive Features |
Primary outcome
Change in Hypoglycemia Fear Survey II (HFS-II) Total Score from Baseline to Follow-up
Time frame: 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 using the Hypoglycemia Fear Survey II (HFS-II), a 33-item questionnaire measuring behaviors related to avoiding hypoglycemia and worries about hypoglycemia and its consequences. Total scores range from 0 to 132, with higher scores indicating greater fear of hypoglycemia.
12 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score from Baseline to Follow-up
Time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Hypoglycemic Confidence Scale (HCS) Mean Score from Baseline to Follow-up
Time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Diabetes Distress Scale (DDS-17) Mean Score from Baseline to Follow-up
Time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Change in Diabetes Empowerment Scale-Short Form (DES-SF) Mean Score from Baseline to Follow-up
Time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Changes in Daily Sleep Quality Assessed by Ecological Momentary Assessment (EMA)
Time frame: 14 days after enrollment and 14 days before study end with one prompt per day (morning)
Changes in Daily Fear of Hypoglycemia Assessed by Ecological Momentary Assessment (EMA)
Time frame: 14 days after enrollment and 14 days before study end with one prompt per day (morning)
Changes in Daily Diabetes- and Glycemic-specific Distress Assessed by Ecological Momentary Assessment (EMA)
Time frame: 14 days after enrollment and 14 days before study end with one prompt per day (evening)
Change in Daily Use of and Responses to Continuous Glucose Monitoring (CGM) Features
Time frame: 14 days after enrollment and 14 days before study end with two prompts per day (morning & evening)
Changes in Time in, Above, and Below Glucose Range
Time frame: From enrollment to the end of the study at 6 weeks
Changes in Glucose Variability (Coefficient of Variation)
Time frame: From enrollment to the end of the study at 6 weeks
Changes in Mean Glucose
Time frame: From enrollment to the end of the study at 6 weeks
Participants' Experiences with CGM Predictive Features
Time frame: After the study period of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 39158974Ehrmann D, Laviola L, Priesterroth LS, Hermanns N, Babion N, Glatzer T. Fear of Hypoglycemia and Diabetes Distress: Expected Reduction by Glucose Prediction. J Diabetes Sci Technol. 2024 Sep;18(5):1027-1034. doi: 10.1177/19322968241267886. Epub 2024 Aug 19.
- Background: PubMed 39158995Glatzer T, Ehrmann D, Gehr B, Penalba Martinez MT, Onvlee J, Bucklar G, Hofer M, Stangs M, Wolf N. Clinical Usage and Potential Benefits of a Continuous Glucose Monitoring Predict App. J Diabetes Sci Technol. 2024 Sep;18(5):1009-1013. doi: 10.1177/19322968241268353. Epub 2024 Aug 19.
- Background: PubMed 40441551Hussain S, Polonsky W, Scibilia R, Glatzer T. Beyond the Trend Arrow: Potential Value of Artificial Intelligence-Supported Glucose Predictions for People with Type 1 Diabetes Using Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2025 Nov;27(11):943-949. doi: 10.1089/dia.2025.0293. Epub 2025 May 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartGuide CGM with Predictive Features in people with Diabetes (DM) and Diabetes Mellitus, run by FIDAM RDC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Ehrmann, Prof. Dr. (+49 7931 96192 42, ehrmann@fidam.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hypoglycemia Fear Survey II (HFS-II) Total Score from Baseline to Follow-up (time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07814508, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.