DIAMOND (continuous glucose monitoring)
Trial question
What is the effect of continuous glucose monitoring in adult patients with T1DM using insulin?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 158
158 patients (70 female, 88 male).
Inclusion criteria: adults with T1DM who were using multiple daily insulin injections and had HbA1c levels of 7.5-9.9%.
Key exclusion criteria: pregnancy; recent or planned use of non-insulin injectable hypoglycemic agents; medical conditions that make it inappropriate or unsafe to target an HbA1c of < 7%; renal disease with GFR < 45; known allergy to medical grade adhesives.
Interventions
N=105 continuous glucose monitoring (continuous glucose monitoring BID and verifying the continuous glucose monitoring glucose concentration with the blood glucose meter before injecting insulin).
N=53 usual care (home blood glucose monitoring at least 4 times daily).
Primary outcome
Reduction in hemoglobin A1c at 24 weeks
1%
0.4%
1.0 %
0.8 %
0.5 %
0.3 %
0.0 %
Continuous glucose
monitoring
Usual
care
Significant
increase ▲
NNT = 166
Significantly greater reduction in HbA1c at 24 weeks (1% vs. 0.4%; AD 0.6%, 95% CI -0.8 to -0.3).
Secondary outcomes
Significant increase in HbA1c < 7.0% at week 24 (18% vs. 4%; AD 15%, 95% CI 0 to 30).
Significant increase in HbA1c < 7.5% at week 24 (38% vs. 11%; AD 31%, 95% CI 12 to 51).
Significant increase in mean minutes per day in range 70-180 mg/dL at 12 and 24 weeks pooled (736 minutes vs. 650 minutes; AD 77 minutes, 95% CI 6 to 147).
Safety outcomes
No significant difference in severe hypoglycemic events.
Conclusion
In adults with T1DM who were using multiple daily insulin injections and had HbA1c levels of 7.5-9.9%, continuous glucose monitoring was superior to usual care with respect to reduction in HbA1c at 24 weeks.
Reference
Roy W Beck, Tonya Riddlesworth, Katrina Ruedy et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378.
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