An interventional study of SmartGuide CGM with Predictive Features in Diabetes (DM), Diabetes Mellitus and Diabetes Mellitus Type 2, sponsored by FIDAM RDC. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by FIDAM RDC · Not applicable, Interventional, and Treatment
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Among 512 studies in Diabetes Mellitus with a site in Germany — 29 open to participants now, 34 under way, 6 of them phase 3. Diabetes Mellitus · Germany.
Among the 512 studies in Diabetes Mellitus with a site in Germany, this one is the 247th largest by planned enrollment of the 454 interventional ones that give a count, is one of 10 that started in 2026, is one of 104 with no phase, reaches primary completion later than 6 of the 33 other live ones, and was the 510th registered.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
Browse Diabetes Mellitus studies →29 of the 512 studies in Diabetes Mellitus with a site in Germany are open now. Recruiting first, the newest first:
Pfizer · Sites in Germany, United States, Brazil and 8 more countries
Ages 18+
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 18+
Novo Nordisk A/S · Sites in Germany
Ages 18–75
Henrik Bo Wiberg Larsson · Sites in Germany, Denmark
Ages 50–80 · Healthy volunteers
University of Bonn · Sites in Germany
Ages 18–60 · Healthy volunteers
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
512 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 132 · Phase 2 64 · Phase 3 136 · Phase 4 32
First in 1994; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 89 is above the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 106 across the 454 interventional studies, 1,000 across the 57 observational. Of the 455 that completed or were terminated, 124 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
371 of 512 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with FIDAM RDC as lead sponsor.
FIDAM RDC has 1 study filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
11 of the studies in Diabetes Mellitus with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT06396871Technische Universität DresdenDeep Phenotyping of Peripheral Blood Cells and Circulating Factors in Metabolic Diseases | 2026-12-31 |
| NCT03052283Medizinische Hochschule Brandenburg Theodor FontaneDevelopment and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score) | 2026-12-31 |
| NCT06982859Eli Lilly and CompanyA Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus | 2027-01 |
| NCT06796582Technical University of MunichReliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors | 2027-02 |
Add all 11 to your calendar (.ics) → With an account.
Among the 512 studies in Diabetes Mellitus with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: SmartGuide CGM with Predictive Features
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.
Also known as: continuous glucose monitoring with predictive algorithm, CGM with predictive algorithm, Accu-Check SmartGuide CGM and Predict App
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.
Time frame: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
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.
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
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.
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
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.
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
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.
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)
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.
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)
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.
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)
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After the study period of 6 weeks
Plan to share: Undecided
Started Feb 2026 (actual). Primary completion is estimated for Oct 2026, 8 months after the start.
Of 1,586 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 8 months is below that.
Counting every sponsor, half of 1,746 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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