An observational study in Diabetes, sponsored by DexCom, Inc.. Status unknown at 25 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by DexCom, Inc. · Observational
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 1,388 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).
Device: Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
Change in hypoglycemic events
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
Time frame: 6 months
Change in A1C
Percent change in A1C lab between CGM use period compared to BGM use period.
Time frame: 6 months
Change in incidence of hypoglycemic events
Percent change of participants with at least one event between CGM use period compared to BGM use period.
Time frame: 6 months
Change in GMSS PRO scores
Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) \[Emotional and Trust subscales\] between CGM use period compared to BGM use period.
Time frame: 6 months
Change in Diabetes Distress Scale (DDS) PRO scores
Percent change in mean scores for the DDS between CGM use period compared to BGM use period.
Time frame: 6 months
Change in Hypoglycemia Fear PRO scores
Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.
Time frame: 6 months
Change in Hypoglycemia Confidence PRO scores
Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2017 (actual). Primary completion is estimated for Dec 2023, 74 months after the start.
Of 109 industry-sponsored observational studies under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 39. This study's planned 74 months is above that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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