NCT05928572

My Diabetes Study - CGM Initiation Approach & Time In Range

Completed NA Results posted Last updated 4 March 2026

What this trial tests

NA trial testing CGM initiation approach in Type 2 Diabetes in 159 participants. Completed in 31 December 2024.

Timeline

25 July 2023

Primary endpoint
16 August 2024

31 December 2024

Quick facts

Lead sponsor	Holly Willis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	159
Start date	25 July 2023
Primary completion	16 August 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• CGM initiation approach

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Holly Willis

Who can join

18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1 Change in CGM-derived Time in Range (TIR) Primary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

% time with glucose 70-180 mg/dL is a core CGM metric; it will be assessed between groups and will be described as the 24-hour period

Group	Value	95% CI
Nutrition Focused Approach (NFA)	25	16 – 34
Self Directed Approach (SDA)	16	7 – 25

Total Healthy Eating Index (HEI) Score Secondary · Post-intervention period (day 40 to day 50)

The total Healthy Eating Index is a measure of diet quality, independent of quantity, used to assess alignment of food intake with the Dietary Guidelines for Americans. HEI will be calculated using standard methods. The scale ranges 0-100; a total score of 100 is possible. Higher scores indicate higher quality diets (better nutritional intake). Differences between groups during the post-intervention period will be described.

Group	Value	95% CI
Nutrition Focused Approach (NFA)	65	61 – 68
Self Directed Approach (SDA)	63	60 – 67

Change in CGM Derived % Time Above >180 mg/dL Secondary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

% time above \>180 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-25	-34 – -17
Self Directed Approach (SDA)	-16	-25 – -6

Change in CGM-derived % Time Above >250 mg/dL Secondary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

% time above \>250 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-14	-19 – -9
Self Directed Approach (SDA)	-6	-12 – -1

Change in CGM-derived % Time Below <70 mg/dL Secondary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

CGM-derived % time \<70 mg/dL is considered a core CGM metric; time below range This will be described as the 24-hour period

Group	Value	95% CI
Nutrition Focused Approach (NFA)	0.1	-0.07 – 0.27
Self Directed Approach (SDA)	-0.23	-0.4 – -0.05

Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL) Secondary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

Time in tight range is considered another CGM metric. This will be described as the 24-hour period

Group	Value	95% CI
Nutrition Focused Approach (NFA)	18	10 – 26
Self Directed Approach (SDA)	12	4 – 20

Odds Ratio for Participants Reaching CGM-derived Consensus Targets by Arm Secondary · From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)

Describes the odds ratio for participants who reach consensus target or \>70% TIR (% time with glucose 70-180 mg/dL)

Group	Value	95% CI
Nutrition Focused Approach (NFA)	7.6	3.3 – 17.4
Self Directed Approach (SDA)	3.1	1.4 – 6.8

Change in Total Energy Intake Secondary · From baseline (day -11) to post-intervention (day 40 to day 50)

Energy intake will be calculated using 24 hour dietary recalls

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-164	-444 – 117
Self Directed Approach (SDA)	-132	-421 – 157

Change in Carbohydrate Intake Secondary · From baseline (day -11) to post-intervention (day 40 to day 50)

Carbohydrate intake will be calculated using 24 hour dietary recalls

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-40	-74 – -7
Self Directed Approach (SDA)	-28	-62 – 7

Change in Calcium Intake Secondary · From baseline (day -11) to post-intervention (day 40 to day 50)

Select micronutrient (calcium) intake will be calculated using 24 hour dietary recalls

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-21	-200 – 159
Self Directed Approach (SDA)	-49	-234 – 136

Change in Total Diabetes Distress Scale-17 Score Secondary · From baseline (day -11) to post-intervention (day 50)

Diabetes distress will be measured using the Diabetes Distress Scale-17 score as indicated by validated survey. The total DDS-17 scale allows for a range of scores from 1 to 6, with a minimum of 1 and a maximum total of 6. A lower score means less distress and is better. Scores less than 2 generally mean little to no distress. A minimal clinically important difference is considered and improvement or worsening of more than 0.25.

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-0.15	-0.39 – 0.10
Self Directed Approach (SDA)	-0.02	-0.37 – 0.33

Change in HbA1c Secondary · From baseline (day -11) to post-intervention (day 50)

HbA1c will be evaluated using point of care assessment

Group	Value	95% CI
Nutrition Focused Approach (NFA)	-0.6	-0.8 – -0.4
Self Directed Approach (SDA)	-0.6	-0.8 – -0.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 2 - Nutrition Focused Approach (NFA)

Serious: 2/50 (4%)

Deaths: 0/50

Phase 2 - Self Directed Approach (SDA)

Serious: 1/52 (2%)

Deaths: 0/52

Phase 1 - Nutrition Focused Approach (NFA)

Serious: 0/64 (0%)

Deaths: 0/64

Phase 1 - Self Directed Approach (SDA)

Serious: 0/60 (0%)

Deaths: 0/60

Serious adverse events (3 terms)

Reaction	System	Phase 2 - Nutrition Focuse…	Phase 2 - Self Directed Ap…	Phase 1 - Nutrition Focuse…	Phase 1 - Self Directed Ap…
Hip Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Brain mass	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Mild epigastric tenderness	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: Hip Pain, Brain mass, Mild epigastric tenderness.

Data from ClinicalTrials.gov NCT05928572 adverse events section.

Sponsor's own description

This study includes two phases. The purpose of Phase 1 of this study is to understand if there is a difference between two ways of introducing a continuous glucose monitor (CGM) to people with type 2 diabetes (T2D). The study will evaluate the effect of using a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose. TIR is the percent of time that someone's glucose is between 70 and 180 mg/dL. It is possible that the approach used to introduce the CGM could impact TIR and other outcomes.

The purpose of Phase 2 of the study is to evaluate the impact of discontinuing CGM for 4 months after the completion of the Phase 1 study intervention on CGM-derived metrics, dietary intake assessment, and patient reported outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. "Now I can see it works!" Perspectives on Using a Nutrition-Focused Approach When Initiating Continuous Glucose Monitoring in People with Type 2 Diabetes: Qualitative Interview Study.
   Willis HJ, Henderson MSG, Zibley LJ, JaKa MM. · · 2025 · cited 5× · PMID 39793006 · DOI 10.2196/67636
2. A Nutrition-Focused Approach During Continuous Glucose Monitoring Initiation in People With Type 2 Diabetes: Using a Theoretical Framework to Unite Continuous Glucose Monitoring and Food Choices.
   Willis HJ, Johnson E, JaKa M. · · 2025 · cited 3× · PMID 38666635 · DOI 10.1177/19322968241247559
3. Effects of Continuous Glucose Monitoring Discontinuation in Adults With Type 2 Diabetes Not Using Insulin.
   Willis HJ, Gustafson SK, Johnson E, JaKa MM, et al · · 2025 · PMID 41466200 · DOI 10.1177/19322968251404496