What is the clinical evidence from this study?

Study design: Observational. Population: Type 2 diabetes mellitus (n=985). Intervention: History of diagnosed depression, depressed mood, and diabetes-related distress vs. Patients without these depression or distress parameters. Primary outcome: Baseline HbA1c in patients with vs. without a history of diagnosed depression (p=<0.001).

July 9, 2015Diabetes Therapy40 citationsOpen Access

Associations Between Glycemic Control, Depressed Mood, Clinical Depression, and Diabetes Distress Before and After Insulin Initiation: An Exploratory, Post Hoc Analysis

Q: What are the key findings of this study?

A history of diagnosed depression and high diabetes-related distress were associated with significantly higher baseline HbA1c levels (10.77% vs 9.36% for diagnosed depression), though insulin therapy improved glycemic control across all groups over 24 months.

HAHaya Ascher‐Svanum AZAnthony J. Zagar DJDingfeng Jiang

Key Result

A history of diagnosed depression and high diabetes-related distress were associated with significantly higher baseline HbA1c levels (10.77% vs 9.36% for diagnosed depression), though insulin therapy improved glycemic control across all groups over 24 months.

Study Design

Type

Observational (n=985)

Multicenter

Yes

Structured PICO

Does insulin initiation improve glycemic control and depression parameters in patients with T2DM and comorbid depression or diabetes distress?

Population

985 patients with type 2 diabetes initiating insulin therapy across 5 European countries, followed for 24 months to assess associations between depression parameters and glycemic control.

Exposure

Insulin therapy initiation (long/intermediate, mixture, basal/bolus, or short-acting)

Outcome

Glycated hemoglobin (HbA1c) levels at baseline and over 24 monthssurrogate

Insulin initiation in T2DM improves glycemic control regardless of baseline depression or diabetes distress, and is associated with a significant decline in depressed mood.

Main Result

Absolute Event Rate: 10.77% vs 9.36%

p-value: p=<0.001

Limitations

Post hoc nature of the analysis
Proxy nature of the studied depression parameters, which were not validated for use as stand-alone measures of depression
Lack of information regarding the specific type of depression diagnosis or when the diagnosis was made
No information available on patients' use of antidepressants during the study
Threshold for high diabetes distress was based on statistical distribution rather than clinical validation
Analyses used observed data, meaning informative missingness from dropouts cannot be ruled out
Proxy nature of the studied depression parameters (not validated stand-alone measures)
Lack of information regarding specific type or timing of depression diagnosis
No information on antidepressant use
Threshold for high distress based on statistical distribution rather than clinical validation
Analyses used observed data which cannot rule out informative missingness

Abstract

INTRODUCTION: Although depression is often associated with poor glycemic control in patients with type 2 diabetes mellitus (T2DM), this observation has been inconsistent. This exploratory, post hoc analysis investigated associations between depression parameters and glycemic control using data from a 24-month, prospective, observational, non-interventional study evaluating glycemic response following insulin initiation for T2DM. METHODS: We analyzed data from a 24-month, prospective, observational study that evaluated glycemic response in patients with T2DM who initiated insulin therapy (N = 985) in 5 European countries. Secondary measures included patient-reported diagnosis of depression at baseline, severity of depressed/anxious mood (EuroQol (EQ)-5D item) and diabetes-related distress (Psychological Distress domain of the Diabetes Health Profile, DHP-18). The latter two measures were assessed at baseline and 5 time points throughout the study. Glycemic control was measured by glycated hemoglobin (HbA1c) at these same time points. Analyses employed t tests to assess the unadjusted baseline difference in HbA1c between patients with and without the respective depression parameter. The potential effect of demographic and clinical confounding variables was controlled through a linear model structure. Patient HbA1c levels were analyzed by presence/absence of a history of diagnosed depression, depressed mood, and diabetes-related distress. RESULTS: Patients with higher depression parameters or distress at baseline had significantly higher rates of microvascular complications at baseline. Patients with a history of diagnosed depression or high diabetes-related distress had higher HbA1c than patients without. HbA1c of patients with or without depressed mood was not significantly different at baseline. The proportion of patients with depressed mood declined after insulin initiation, whereas the proportion of patients with high diabetes-related distress did not significantly change. HbA1c improved following insulin initiation, regardless of presence/absence of studied depression/distress parameters at baseline. CONCLUSION: History of diagnosed depression, diabetes-related distress, and depressed mood were associated with a higher rate of microvascular complications. Diagnosed depression and diabetes-related distress also showed higher HbA1c at baseline when insulin was initiated. Insulin therapy improved glycemic control, while preexisting depressed mood declined and diabetes-related distress remained unchanged.

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