Phase 4
Completed N=10
Remission Through Early Monitored Insulin Therapy - Duration Month
Source: ClinicalTrials.gov NCT03670641 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months — 9.00; 6.81; 7.13; 7.26 percentage of glycosylated hemoglobin
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
REMIT-DM is a feasibility pilot study where participants will be recruited soon after their diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four weeks with titrations of insulin guided by glucose levels and trends provided by a continuous glucose monitor (CGM), with the purpose of achieving diabetes remission.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months |
9.00; 6.81; 7.13; 7.26; 6.88 | — |
| SECONDARY Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention |
1; 2; 2; 4 | — |
| SECONDARY Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention |
4 | — |
| SECONDARY See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale |
8.90; 7.62 | — |
| SECONDARY Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention |
46.3; 80.67 | — |
| SECONDARY Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period |
6; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18
- A1C criteria - >7.0
- Newly diagnosed with T2D within 4 years
- Lifestyle controlled
- Subject may be on up to 2 medications for diabetes.
- Smart phone or home computer compatible with DEXCOM CLARITY software
- English speaking
- Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery
Exclusion Criteria
- Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies
- Pregnant
- Chronic Kidney Disease (CKD) Stage IV or greater
- Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator)
- No access to computer for downloading CGM
- BMI <18.0
Data sourced from ClinicalTrials.gov (NCT03670641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.