NCT04721145: IMPaCT

CGM Use in Poorly Controlled Youth With Type 1 Diabetes

Completed NA Results posted Last updated 4 August 2023

What this trial tests

NA trial testing Dexcom G6 Continuous Glucose Monitor in Type 1 Diabetes in 26 participants. Completed in 28 June 2022.

Timeline

25 January 2021

Primary endpoint
28 June 2022

28 June 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	26
Start date	25 January 2021
Primary completion	28 June 2022
Estimated completion	28 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Dexcom G6 Continuous Glucose Monitor

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →
• Hypoglycemia — all drugs for Hypoglycemia →
• High Blood Sugar — all drugs for High Blood Sugar →

Sponsor

Johns Hopkins University

Who can join

Adults 5 to 21, any sex, with Type 1 Diabetes or Hypoglycemia. 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.

Change in Personal CGM Use Primary · Baseline and 3 months

Evaluate whether there is any change in uptake of personal CGM after 10-day trial.

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	22
Dexcom G6 Continuous Glucose Monitor	4

Change in the Percent Time in Range Glucose Control Secondary · 1-5 days and 6-10 days

Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM

1-5 days

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	41.9	± 21.2

6-10 days

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	32.8	± 15.2

Change in Hemoglobin A1c Secondary · Baseline, 3-6 months

Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit

Baseline

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	10.9	± 2.6

3-6 month follow up

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	10.8	± 2.6

Using Personal CGM Secondary · 3-6 months

Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM

Group	Value	95% CI
Dexcom G6 Continuous Glucose Monitor	9

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexcom G6 Continuous Glucose Monitor

Serious: 5/26 (19%)

Deaths: 0/26

Serious adverse events (3 terms)

Reaction	System	Dexcom G6 Continuous Gluco…
DKA admission	Endocrine disorders	—
ER Visit, renal stone	Renal and urinary disorders	—
Abdominal Pain	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Dexcom G6 Continuous Gluco…
Otalgia of both ears	Ear and labyrinth disorders	—

Most-reported serious reactions: DKA admission, ER Visit, renal stone, Abdominal Pain.

Data from ClinicalTrials.gov NCT04721145 adverse events section.

Sponsor's own description

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.

Publications & conference data

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

1. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study.
   Lin T, Manfredo JA, Illesca N, Abiola K, et al · · 2023 · cited 11× · PMID 36223197 · DOI 10.1089/dia.2022.0347
2. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes.
   Phu A, Lin T, Manfredo JA, Brown EA, et al · · 2023 · PMID 40303266 · DOI 10.1155/2023/1979635