Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Continuous Glucose Monitoring (CGM), Degludec Insulin, Self-monitoring blood glucose (SMBG)
Brief summary
The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).
Detailed description
This is an 18-week study designed to investigate the effect of a continuous glucose monitor (CGM) based titration algorithm versus a standard titration by self-monitoring blood glucose (SMBG) on glycemic control in Type 2 Diabetes (T2DM) participants using insulin Degludec. After 2 weeks of blinded CGM baseline observation, participants are randomized 2:1 to CGM-based titration or standard titration by SMBG for 16 weeks. In the SMBG group, all titrated doses will be reviewed by a study physician prior to use and participants will wear a blinded CGM during the whole study. After completion of the 16-week titration, participants are followed up for 2 days. Participants will be divided related to use of sulfonylureas or glinides with a maximum cap of nine participants being treated with sulfonylureas and glinides to complete the study.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform
Sponsors
University of Virginia
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, randomized, parallel group, active-comparator clinical trial of CGM based titration of insulin Degludec vs. standard titration by SMBG.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older at signing of informed consent 2. Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening 3. Hemoglobin A1c between 7-9% and measured by local lab at screening 4. On daily basal insulin for at least 90 days before inclusion into the study 5. Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include: 1. Metformin 2. Sulfonylureas 3. Meglitinides (glinides) 4. Dipeptidyl peptidase 4 (DPP-4) inhibitors 5. Sodium glucose co-transporter 2 (SGLT2) inhibitors 6. Thiazolidinediones 7. Alpha-glucosidase inhibitors 8. Oral combination products (for the allowed individual oral anti-diabetic drugs) 9. Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs) 10. If on sulfonylureas or glinides, willingness to reduce dose by 50%
Exclusion criteria
1. Hypersensitivity to Degludec 2. Use of an insulin pump 3. Use of a short-acting insulin 4. Participation or has participated in another trial within 90 days of the screening visit 5. Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method 6. Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. 7. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit 8. Known skin reactions to CGM adhesives 9. Current/prior use of CGM within 30 days of the screening visit 10. Any planned surgery or procedures where basal insulin would be decreased or held in anticipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) | From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks) | Change in CGM-measured time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TIR = TIR (weeks 14-16) - TIR (baseline). Change in TIR is measured with percentage points as TIR is measured with the percentage time spent within the range 3.9-10.0 mmol/L (70-180 mg/dL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From week 0 to week 16 | Percent change in HbA1c measured as percentage |
| Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL) | From baseline (week -2-0) to week 14-16 | Percent change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TITR = TITR (weeks 14-16) - TITR (baseline). |
| Change in Time Above 10.0 mmol/L (180 mg/dL) | From baseline (week -2-0) to week 14-16 | Percent of time spent above 10.0 mmol/L (180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR = TAR (weeks 14-16) - TAR (baseline). |
| Change in Time Above 13.9 mmol/L (250 mg/dL) | From baseline (week -2-0) to week 14-16 | Percent of time spent above (TAR2) 13.9 mmol/L (250 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR2 = TAR2 (weeks 14-16) - TAR2 (baseline). |
| Change in Mean Glucose Level | From baseline (week -2-0) to week 14-16 | The average CGM-measured blood glucose level (mg/dL). |
| Change in Continuous Glucose Monitoring Coefficient of Variation (%) | From baseline (week -2-0) to week 14-16 | The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level. |
| Change in Time Below 3.9 mmol/L (70 mg/dL) | From baseline (week -2-0) to week 14-16 | Percent of time spent below (TBR) 3.9 mmol/L (70 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR = TBR (weeks 14-16) - TBR (baseline). |
| Change in Time Below 3.0 mmol/L (54 mg/dL) | From baseline (week -2-0) to week 14-16 | Percent of time spent below (TBR2) 3.0 mmol/L (54 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR2 = TBR2 (weeks 14-16) - TBR2 (baseline). |
| Basal Insulin Dose Changes | From week 0 to week 16 | The investigator changes the dose from baseline to week 16 |
| Percent Acceptance Rate | From week 0 to week 16 | Investigator acceptance rate of weekly dose guidance from Experimental arm only. Measure is calculated for each participant as 100x(number of accepted doses)/(number of recommended doses). Median and IQR is reported. |
Countries
United States
Contacts
STUDY_CHAIRRalf M Nass, MD
University of Virginia
Participant flow
Recruitment details
39 participants signed consent at two clinical sites between Nov 2023 - Sept 2024. Nine did not pass screening or withdrew prior to randomization; two participants dropped after randomization.
Pre-assignment details
Enrollment was defined when the ICF was signed by participant & study team. Once screening & training were completed, participants began a 2-wk at home use of a blinded CGM. Participants were asked to follow their UC without changes in their insulin parameters. CGM equipment was returned to the study team to facilitate downloading the data from the CGM, which must have been used 10 out of 14 days & a day must contain 70% measurements to be counted.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.8 |
| BMI | 30.6 kg/m2 STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 0 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
None listed